- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02976441
Autologous Stem Cell Collection and Reinfusion in Newly Diagnosed High Grade Gliomas
February 16, 2017 updated by: Washington University School of Medicine
Feasibility of Autologous Stem Cell Collection and Reinfusion in Newly Diagnosed High Grade Gliomas
The investigators hypothesize that this study will show that sufficient lymphocyte stem cell can be harvested prior chemoradiation and be reinfused back after treatment, and at least 5 of the 10 patients (50%) will achieve an absolute increase of lymphocyte counts of 300 cells/mm^3 four weeks after stem cell reinfusion in high grade glioma patients.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Early Phase 1
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically confirmed newly diagnosed high grade glioma by pathology (WHO grade III or IV).
- At least 18 years of age.
- Karnofsky performance status ≥ 60%
Normal bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 1,500/mcl
- Platelets ≥ 100,000/mcl
- Hematocrit ≥ 30%
- Absolute lymphocyte count ≥ 1000/mcl Blood transfusions are permitted to allow potential participant to meet these criteria.
- Post-operative treatment plan must include standard radiation and temozolomide.
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
- Prior treatment with radiation therapy, chemotherapy, immunotherapy, biologic agents (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK, or gene therapy), or hormonal therapy. Glucocorticoid therapy is allowed.
- Anti-VEGF therapy within 6 weeks of registration.
- A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
- Currently receiving any investigational agents that might affect lymphocytes. Patients receiving Novocure are allowed on study.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to filgrastim or plerixafor or other agents used in the study.
- Fresh CNS bleed as evident by MRI or CT.
- Contraindicated for anticoagulation.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
- Known HIV-positivity.
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 |
Intervention / Treatment |
---|---|
Experimental: Focal RT, Temozolomide, Stem Cell Collection/Reinfusion
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of lymphocyte stem cell harvesting and reinfusion in patients as measured by the number of patients from whom 1-5x10e6 lymphocyte stem cells are collected and successfully reinfused without an adverse event
Time Frame: Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months)
|
The study will provide preliminary evidence of efficacy if ≥5 of 10 patients (50%) achieve an increase over baseline in absolute lymphocyte counts (ALC) ≥300 cells/mm3 at 4 weeks after reinfusion from their baseline lymphocyte counts.
|
Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of lymphocyte stem cells that can be harvested from this patient population
Time Frame: Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months)
|
Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months)
|
|
Proportion of patients who have an increase in lymphocyte of ≥300 cells/mm^3 after autologous stem cell reinfusion.
Time Frame: 4 weeks after stem cell reinfusion
|
4 weeks after stem cell reinfusion
|
|
Duration of lymphocyte rise following stem cell reinfusion
Time Frame: Up to 6 months after stem cell reinfusion (approximately 9 months)
|
Up to 6 months after stem cell reinfusion (approximately 9 months)
|
|
Changes in lymphocyte subtypes following collection and reinfusion
Time Frame: Up to 6 months after stem cell reinfusion (approximately 9 months)
|
Lymphocyte subtypes will be monitored by flow cytometry at the time of stem cell collection, prior to autologous stem cell reinfusion, and then monthly for 6 months.
|
Up to 6 months after stem cell reinfusion (approximately 9 months)
|
Changes in series of cytokine levels following collection and reinfusion
Time Frame: Up to 6 months after stem cell reinfusion (approximately 9 months)
|
Cytokine levels will be checked by ELISPOT at the time of stem cell collection, weekly during radiation therapy/temozolomide (up to 6 weeks), prior to autologous stem cell reinfusion, and then monthly for 6 months.
|
Up to 6 months after stem cell reinfusion (approximately 9 months)
|
Safety and toxicities with stem cell collection and reinfusion as measured by grade and frequency of adverse events
Time Frame: Up to 6 months after stem cell reinfusion (approximately 9 months)
|
the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all adverse event/toxicity reporting.
|
Up to 6 months after stem cell reinfusion (approximately 9 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jian Li Campian, M.D., Ph.D., Washington University School of Medicine
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.
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
January 1, 2017
Primary Completion (Anticipated)
February 1, 2018
Study Completion (Anticipated)
February 1, 2018
Study Registration Dates
First Submitted
November 23, 2016
First Submitted That Met QC Criteria
November 23, 2016
First Posted (Estimate)
November 29, 2016
Study Record Updates
Last Update Posted (Actual)
February 20, 2017
Last Update Submitted That Met QC Criteria
February 16, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Eye Diseases
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Nervous System Neoplasms
- Optic Nerve Diseases
- Cranial Nerve Diseases
- Peripheral Nervous System Neoplasms
- Cranial Nerve Neoplasms
- Optic Nerve Neoplasms
- Glioma
- Ependymoma
- Astrocytoma
- Oligodendroglioma
- Optic Nerve Glioma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Temozolomide
Other Study ID Numbers
- 15-x135
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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