Multi-peptide Vaccine With Basilixumab for Breast Cancer

June 21, 2019 updated by: Abramson Cancer Center of the University of Pennsylvania

A Study of hTERT/Survivin Multi-Peptide Vaccination With Basiliximab And Prevnar For Patients With Metastatic Breast Cancer

Eligible patients will receive subcutaneous vaccinations of the hTERT/survivin/CMV multipeptide vaccine and GM-CSF over a 24 month period. All patients will receive basiliximab 20 mg 1 day prior to the start of vaccinations. Prevnar vaccine will be administered at the time of Vaccines 1,3, and 5. Patients who remain clinically stable after the fourth vaccine, may continue to receive vaccinations every 4 weeks for up to 2 years.

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

hTERT is widely found in breast cancer cells and has a role in tumor growth and development, making it attractive for immunotherapy. Also, recent data suggest that breast cancer is potentially responsive to immunological therapies. In one trial, patients with advanced cancer received a series of hTERT vaccinations and 4 of 7 patients with advanced breast or prostate carcinoma developed hTERT-specific T lymphocytes. Partial tumor regression was observed in 1 patient. In a second trial, 19 HLA A2+ patients with metastatic breast cancer were vaccinated with hTERT 1540 peptide in adjuvant with GM-CSF. 68% of patients exhibited immunological responses with development of CD8+ hTERT-specific T-cells. Overall survival of vaccine responders was signifiantly better than the overall survival on non-responders. In order to expand the number of possible immune responses and to potentially bypass immune tolerance, multiple peptides have been added to the vaccine. In addition, the monoclonal antibody basiliximab is included to decrease the regulatory T cells which prevent the immune system to work against the tumor, and GM-CSF and Prevnar are used to boost the immune system. Subjects will receive a maximum of 28 vaccinations over a 24 months period.

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.
10

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.
  • Early Phase 1

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center, University of Pennsylvania

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stage IV (AJCC) breast cancer patients who have failed at least one conventional therapy for metastatic disease.
  • HLA-A2 blood positive
  • Evidence of measurable or evaluable disease by clinical, radiographic, or laboratory assessment.
  • Age greater than 18 years old
  • Baseline Eastern Cooperative Oncology Group (ECOG) Clinical Performance Status 0 or 1
  • Life expectancy greater than 6 months
  • Adequate hematologic function established within 14 days before treatment: WBC equal to or greater than 3.0, Plt equal to or greater than 75,000, Hgb equal to or greater than 10 g/dl
  • Adequate renal function established within 14 days before treatment defined as serum creatinine less than 1.5 times upper limit of normal
  • Adequate hepatic function established within 14 days before treatment defined as: Total bilirubin, less than 1.5 times upper limit of normal, and ALT and AST less than 2.5 times upper limit of normal
  • Contrast CT and/or MRI of the brain negative for central nervous system metastases within 30 days of treatment
  • Women of child bearing potential must have a negative pregnancy test (blood or urine) within 14 days before treatment and agree to use appropriate contraception from study screen through the duration of the trial. Men must agree to use appropriate contraception from study screen through the duration of the trial.
  • Signed and dated written informed consent

Exclusion Criteria:

  • History of brain metastases within the last four years
  • Positivity for HIV-1/HIV-2, Hepatitis B virus, and Hepatitis C virus active infection
  • The use of the following within 14 days before treatment: Chemotherapy, Radiation therapy, Immunosuppressive drugs, Systemic glucocorticoids, Hematopoietic growth factors, Experimental therapy
  • Use of anti-coagulants such as coumadin, heparin, or Lovenox within 14 days before treatment, with the exception of low dose anti-coagulants to maintain intravenous catheter patency.
  • Initiation of hormonal agent (such as tamoxifen, anastrazole, or letrozole) in the 30 days before treatment. 6. Patients who have been on a hormonal agent for at least 30 days prior to treatment with progressive or stable disease are permitted to enroll, but required to stay on this hormonal agent for the duration of the study.
  • Initiation of immunotherapy (such as trastuzumab-Herceptin) in the 30 days before treatment. Patients who have been on trastuzumab for at least 30 days prior to treatment with progressive or stable disease are permitted to enroll, but required to stay on trastuzumab for the duration of the study.
  • History of bone marrow or stem cell transplantation (allogeneic or autologous)
  • Pregnant women or nursing mothers
  • History of alcohol abuse or illicit drug use within 12 months of study initiation
  • Clinically significant comorbid disease or other underlying condition, including major autoimmune disorders that would contraindicate study therapy or confuse interpretation of study results
  • Significant psychiatric disorder and any other reason in the Investigators opinion that would jeopardize protocol compliance or compromise the patients ability to give informed consent.

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: N/A
  • Interventional Model: Single Group 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: hTERT/Survivin Multi-Peptide Vaccination
single-arm Phase I study for patients with metastatic breast cancer who have failed at least one regimen for metastatic disease
Biological: hTERT

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
Time Frame
Number of Adverse Events
Time Frame: 1st dose of basiliximab to 30 days after the last vaccination
1st dose of basiliximab to 30 days after the last vaccination

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.
Abramson Cancer Center of the University of Pennsylvania

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: Kevin Fox, MD, Abramson Cancer Center of the University of Pennsylvania

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

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.
June 1, 2012

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.
November 20, 2015

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.
November 20, 2015

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).
August 6, 2012

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.
August 7, 2012

First Posted (Estimate)

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.
August 8, 2012

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.
June 25, 2019

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.
June 21, 2019

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.
June 1, 2019

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.
  • UPCC 03111

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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