Vaccine Immunotherapy for Recurrent Medulloblastoma and Primitive Neuroectodermal Tumor (Re-MATCH)

July 23, 2026 updated by: University of Florida

Recurrent Medulloblastoma and Primitive Neuroectodermal Tumor Adoptive T Cell Therapy During Recover From Myeloablative Chemotherapy and Hematopoietic Stem Cell Transplantation

Immunotherapy is a specific approach to treating cancer that has shown promise in adult patients for the treatment of melanoma, malignant brain tumors, and other cancers. The study investigators will use the experience they have gained from these studies to try to improve the outcome for children affected by a recurrent brain tumor.

Approximately 35 patients with first recurrence of medulloblastoma (reMB)/supratentorial primitive neuroectodermal tumors (PNETs) will be treated with tumor-specific immune cells and dendritic cell vaccines to see what impact they have on the tumor.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Malignant brain tumors now represent the most frequent cause of cancer death in children. Despite aggressive and highly toxic multi-modality therapy including surgery, craniospinal radiation, and high-dose chemotherapy coupled with peripheral blood stem cell transplantation, almost half the children diagnosed with the most common malignant brain tumors, medulloblastoma (MB) and primitive neuroectodermal tumors (PNET), will still die from recurrent disease. Furthermore, survivors are often left with severe and lifelong treatment-associated cognitive and motor deficits. The development of more effective and tumor-specific therapies that will not add further toxicity to existing treatments is paramount in improving clinical outcomes for children affected by MB/PNETs. Immunotherapy targeting tumor-specific antigens expressed within brain tumors is a modality potentially capable of meeting this clear and urgent need.

Despite considerable advancements and promising clinical results observed in immunotherapy trials directed against adult malignant brain tumors, efforts in the immunologic treatment of pediatric brain tumors have been limited to relatively few notable studies. This is due, at least in part, to the often limited viable tumor tissue available for tumor cell-based vaccine preparations, and the lack of identification of consistently expressed tumor-specific antigens within these cancers.

The use of total tumor RNA (TTRNA)-loaded dendritic cells (DCs) was pioneered at Duke University, as a novel platform for inducing potent immunologic responses against the variety of uncharacterized and patient-specific antigens present within malignant tumor cells. Duke demonstrated that sufficient RNA for clinical vaccine preparations can be amplified with high fidelity using existing molecular technologies from as few as 500 isolated pediatric and adult brain tumor cells, thus allowing vaccine preparation from surgical biopsies and even microdissected archival tumor specimens.

Immunotherapy administered during recovery from chemotherapy may have tremendous advantages, as adoptive cellular therapy following lymphodepletive conditioning regimens has emerged as the most effective treatment strategy for advanced and refractory melanoma. Our hypothesis is that DC + ex vivo expanded Autologous Lymphocyte Transfer (xALT) therapy targeting recurrent MB/PNETs during recovery from myeloablative chemotherapy will be safe and will prolong survival in children and young adults with recurrent MB/PNETs.

In this study, the investigators will treat patients with first recurrence reMB/PNETs after completion of definitive radiation therapy with autologous tumor-specific T cell immunotherapy (TTRNA-xALT) plus TTRNA-loaded dendritic cell vaccine.

Following surgical resection, biopsy, or cytology examination with confirmatory pathologic diagnosis, patients will be enrolled into Group A (high-dose chemotherapy or HDC) or Group B (non-myeloablative or NMA salvage chemotherapy) based on eligibility for HDC. Patients with localized relapse and have not failed HDC+ peripheral blood stem cell transplant (PBSCT) previously will be enrolled into Group A. Patients with disseminated disease, have previously failed HDC+PBSCT, or are otherwise considered poor candidates for HDC based on overall health status, but otherwise meet eligibility criteria, will be enrolled into Group B. All patients will receive DC + xALT therapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Children's National Medical Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Screening:

  • Age ≤ 30 years of age.
  • Suspected first recurrence/progression of MB/PNET since completion of definitive focal +/- craniospinal irradiation. Disease progression prior to receiving definitive focal +/- craniospinal irradiation will not disqualify patients from enrollment if they have subsequently failed definitive radiotherapy and are at first recurrence/progression at time of enrollment. Patients who are unable to receive radiation therapy due to genetic disorders that put them at significant risk for radiation-induced secondary malignancies (i.e. Gorlin's syndrome or NF1 mutation) are eligible for enrollment at first disease recurrence/progression.

Re-MATCH Protocol:

  • Patients must have histologically confirmed recurrent MB/PNET that is a first relapse/progression after completion of definitive radiotherapy +/- craniospinal irradiation. Patients with a first relapse/progression who are unable to receive radiation therapy due to genetic disorders that put them at significant risk for radiation-induced secondary malignancies (ie. Gorlin's syndrome or NF1 mutation) are eligible for enrollment.
  • Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration.
  • Karnofsky Performance Status of ≥ 50% or Lansky Performance Score of ≥ 50.
  • Absolute Neutrophil Count (ANC) ≥ 1000/µl (unsupported).
  • Platelets ≥ 100,000/µl (unsupported).
  • Hemoglobin > 8 g/dL (may be supported).
  • Serum creatinine ≤ upper limit of institutional normal
  • Bilirubin ≤ 1.5 times upper limit of normal for age.
  • Serum Glutamic Oxaloacetic Transaminase (ALT) ≤ 3 times institutional upper limit of normal for age.
  • Serum Glutamic Oxaloacetic Transaminase (AST) ≤ 3 times institutional upper limit of normal for age.
  • Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study.
  • Patient or patient guardian consent to peripheral blood stem cell (PBSC) and/or bone marrow harvest following registration if PBSC or bone marrow (CD34 count of at least 2x10^6/kg) has not been previously stored and available for use.
  • Signed informed consent according to institutional guidelines must be obtained prior to registration.

Exclusion Criteria:

  • Pregnant or need to breast feed during the study period.
  • Active infection requiring treatment or an unexplained febrile (> 101.5F) illness.
  • Known immunosuppressive disease, human immunodeficiency virus infection, or carriers of Hepatitis B or Hepatitis C virus.
  • Patients with active renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), or pulmonary disease.
  • Patients receiving concomitant immunosuppressive agents for medical condition.
  • Patients who need definitive radiotherapy for treatment of recurrent MB/PNET. Focal boost radiotherapy may be delivered prior to immunotherapy if required for local control.
  • Patients receiving any other concurrent anticancer or investigational drug therapy.
  • Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction).
  • Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A
High dose chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs.
Biological: TTRNA-xALT
TTRNA-xALT 3 x 10^7/kg by intravenous injection once.
Biological: TTRNA-DCs
TTRNA-DCs 1 x 10^7 by intradermal injection every 2 weeks for 3 total doses.
Experimental: Group B
NMA Salvage chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs.
Biological: TTRNA-xALT
TTRNA-xALT 3 x 10^7/kg by intravenous injection once.
Biological: TTRNA-DCs
TTRNA-DCs 1 x 10^7 by intradermal injection every 2 weeks for 3 total doses.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
12 Month Progression-free Survival (PFS-12)
Time Frame: up to 12 months

PFS-12 is the number of participants (%) with PFS at 12 months. PFS is defined as time interval from date of first DC vaccine to date of progression (death is also treated as progression) or censoring, whichever happens first.

The PFS-12 of Historical Benchmark is 33%. The granular PFS of Historical Bechmark is 4,16, 5, 12, 14, 7, 5, 5, 12, 9, 24 and 13 months (Gururangan et al,. Neuro Oncol. 2008, Table 3)
up to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Radiographic Response Rate
Time Frame: Baseline MRI (prior to Adoptive Cellular Therapy (ACT)) compared to post-ACT MRI (approximately 8 weeks post-baseline MRI)
Objective Response Rate (ORR), defined as the proportion of subjects who show partial or complete response (CR+PR) to therapy, SD (stable disease), and PD (progressive disease) or not assessable, using RECIST criteria based on their best overall response over 8 weeks when comparing pre-ACT vs. post-ACT MRI.
Baseline MRI (prior to Adoptive Cellular Therapy (ACT)) compared to post-ACT MRI (approximately 8 weeks post-baseline MRI)
Change in Cytokine Profile for IFNg
Time Frame: baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
We will measure serum cytokines in peripheral blood pre and post ACT therapy for patients in Arm A and Arm B. We will compare baseline (pre-ACT) to post treatment (both TTRNA-xALT and TTRNA-DCs vaccines administered) changes for each arm. Longitudinal difference baseline to Day 14 and 28 with each patient serving as own control using mixed linear effect model.
baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
Overall Survival (OS) Rate
Time Frame: baseline up to 12 months

12-month OS calculated based on benchmark.

OS-12 is the proportion of participants with OS at 12 months.
baseline up to 12 months
Change in Type 1 Interferon
Time Frame: baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
We will measure change in cellular immunity in peripheral blood pre and post therapy for patients in Arm A and Arm B. We will compare baseline to post treatment changes for each arm. Longitudinal difference baseline to Day 28 (including Day 14) with each patient. OS Univariable Cox Regression with Change in Cellular Immunity was applied. The Hazard Ratio with 95% CI reported.
baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
Change in Type 2 Interferon
Time Frame: baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
We will measure change in cellular immunity in peripheral blood pre and post therapy for patients in Arm A and Arm B. We will compare baseline to post treatment changes for each arm. Longitudinal difference baseline to Day 28 (including Day 14) with each patient. OS Univariable Cox Regression with Change in Cellular Immunity was applied. The Hazard Ratio with 95% CI reported.
baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
Change in Percentage of CD8 Naive T Cells in PBMC
Time Frame: baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
We will measure change in lymphocyte phenotype in peripheral blood pre and post therapy for patients in Arm A and Arm B. We will compare baseline to post treatment changes for each arm. Longitudinal difference baseline (pre-treatment) to 28 days with each patient serving as own control using mixed linear effect model.
baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
Change in Cytokine Profile for IL10
Time Frame: baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
We will measure serum cytokines in peripheral blood pre and post therapy for patients in Arm A and Arm B. We will compare baseline to post treatment changes for each arm. Longitudinal difference baseline to Day 14 and 28 with each patient serving as own control using mixed linear effect model.
baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
Change in Cytokine Profile for IL12p70
Time Frame: baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
We will measure serum cytokines in peripheral blood pre and post therapy for patients in Arm A and Arm B. We will compare baseline to post treatment changes for each arm. Longitudinal difference baseline to Day 14 and 28 with each patient serving as own control using mixed linear effect model.
baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
Change in Cytokine Profile for IL2
Time Frame: baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
We will measure serum cytokines in peripheral blood pre and post therapy for patients in Arm A and Arm B. We will compare baseline to post treatment changes for each arm. Longitudinal difference baseline to Day 14 and 28 with each patient serving as own control using mixed linear effect model.
baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
Change in Cytokine Profile for IL4
Time Frame: baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
We will measure serum cytokines in peripheral blood pre and post therapy for patients in Arm A and Arm B. We will compare baseline to post treatment changes for each arm. Longitudinal difference baseline to Day 14 and 28 with each patient serving as own control using mixed linear effect model.
baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
Change in Cytokine Profile for IL6
Time Frame: baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
We will measure serum cytokines in peripheral blood pre and post therapy for patients in Arm A and Arm B. We will compare baseline to post treatment changes for each arm. Longitudinal difference baseline to Day 14 and 28 with each patient serving as own control using mixed linear effect model.
baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
Change in Cytokine Profile for TNFa
Time Frame: baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
We will measure serum cytokines in peripheral blood pre and post therapy for patients in Arm A and Arm B. We will compare baseline to post treatment changes for each arm. Longitudinal difference baseline to Day 14 and 28 with each patient serving as own control using mixed linear effect model.
baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
Change in TLR Activation Status
Time Frame: baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
We will measure change in TLR activation status in peripheral blood pre and post therapy for patients in Arm A and Arm B. We will compare baseline to post treatment changes for each arm. Longitudinal difference baseline to Day 14 and 28 with each patient serving as own control using mixed linear effect model. We quantified pathway activity using GSVA applied to normalized RNA-seq expression data. The enrichment score for each sample was defined as the maximum deviation from zero of this running sum, yielding a dimensionless GSVA score that represents the relative coordinated up- or down-regulation of TLR pathway genes within that sample compared to the background transcriptome. Higher GSVA score represents upregulation and lower GSVA score represents downregulation. There is no clinical relevance threshold.
baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
Change in Percentage of CD8 Memory T Cells in PBMC
Time Frame: baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
We will measure change in lymphocyte phenotype in peripheral blood pre and post therapy for patients in Arm A and Arm B. We will compare baseline to post treatment changes for each arm. Longitudinal difference baseline to 28 days with each patient serving as own control using mixed linear effect model.
baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
Change in Percentage of CD4 Naive T Cells in PBMC
Time Frame: baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
We will measure change in lymphocyte phenotype in peripheral blood pre and post therapy for patients in Arm A and Arm B. We will compare baseline to post treatment changes for each arm. Longitudinal difference baseline to 28 days with each patient serving as own control using mixed linear effect model.
baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
Change in Percentage of CD4 Memory T Cells in PBMC
Time Frame: baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
We will measure change in lymphocyte phenotype in peripheral blood pre and post therapy for patients in Arm A and Arm B. We will compare baseline to post treatment changes for each arm. Longitudinal difference baseline to 28 days with each patient serving as own control using mixed linear effect model.
baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
Change in Percentage of Treg T Cells in PBMC
Time Frame: baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
We will measure change in lymphocyte phenotype in peripheral blood pre and post therapy for patients in Arm A and Arm B. We will compare baseline to post treatment changes for each arm. Longitudinal difference baseline to 28 days with each patient serving as own control using mixed linear effect model.
baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
Change in Percentage of NK Cells in PBMC
Time Frame: baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)
We will measure change in lymphocyte phenotype in peripheral blood pre and post therapy for patients in Arm A and Arm B. We will compare baseline to post treatment changes for each arm. Longitudinal difference baseline to 28 days with each patient serving as own control using mixed linear effect model.
baseline prior to immunotherapy to 28 days post-vaccine #1 (both TTRNA-xALT and TTRNA-DCs vaccines administered)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Department of Defense

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Duane Mitchell, MD, PhD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 7, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 28, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB201500502
  • W81XWH-10-1-0089 (Other Grant/Funding Number: Department of Defense)
  • CDMRP-PRO93877 (Other Identifier: Department of Defense)
  • OCR13166 (Other Identifier: University of Florida)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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