Autologous Stem Cell Collection and Reinfusion in Newly Diagnosed High Grade Gliomas

Sponsor

Washington University School of Medicine (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02976441

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Astrocytoma Brainstem Glioma Ependymoma Mixed Glioma Oligodendroglioma Optic Nerve Glioma	Radiation: Radiation therapy Drug: Temozolomide Procedure: Stem cell collection Procedure: Stem cell infusion	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Feasibility of Autologous Stem Cell Collection and Reinfusion in Newly Diagnosed High Grade Gliomas

Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Feb 1, 2018

Anticipated Study Completion Date :

Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Focal RT, Temozolomide, Stem Cell Collection/Reinfusion Autologous stem cell collection will be performed 1-4 days prior to initiating radiation therapy and temozolomide Focal radiation therapy: standard of care dose daily for approximately 6 weeks Temozolomide: standard of care dose by mouth daily for 6 weeks with radiation 2-7 days after the end of the radiation therapy and temozolomide the stem cells will be reinfused into the patient Temozolomide: standard of care dose by mouth on days 1-5 every 28 days for 6 months following a 4-6 week rest period after the initial radiation and temozolomide	Radiation: Radiation therapy Drug: Temozolomide Other Names: Temodar® Procedure: Stem cell collection Procedure: Stem cell infusion

Arm

Intervention/Treatment

Experimental: Focal RT, Temozolomide, Stem Cell Collection/Reinfusion

Autologous stem cell collection will be performed 1-4 days prior to initiating radiation therapy and temozolomide Focal radiation therapy: standard of care dose daily for approximately 6 weeks Temozolomide: standard of care dose by mouth daily for 6 weeks with radiation 2-7 days after the end of the radiation therapy and temozolomide the stem cells will be reinfused into the patient Temozolomide: standard of care dose by mouth on days 1-5 every 28 days for 6 months following a 4-6 week rest period after the initial radiation and temozolomide

Radiation: Radiation therapy

Drug: Temozolomide

Other Names:

Temodar®

Procedure: Stem cell collection

Procedure: Stem cell infusion

Outcome Measures

Primary Outcome Measures

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 [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.

Secondary Outcome Measures

Number of lymphocyte stem cells that can be harvested from this patient population [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. [4 weeks after stem cell reinfusion]
Duration of lymphocyte rise following stem cell reinfusion [Up to 6 months after stem cell reinfusion (approximately 9 months)]
Changes in lymphocyte subtypes following collection and reinfusion [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.
Changes in series of cytokine levels following collection and reinfusion [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.
Safety and toxicities with stem cell collection and reinfusion as measured by grade and frequency of adverse events [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.