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

NCT ID: NCT02976441

Last Updated: 2017-02-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-02-28

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.

Conditions

Astrocytoma; Brainstem Glioma; Ependymoma; Mixed Glioma; Oligodendroglioma; Optic Nerve Glioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Radiation therapy

Intervention Type: RADIATION

Temozolomide

Intervention Type: DRUG

Stem cell collection

Intervention Type: PROCEDURE

Stem cell infusion

Intervention Type: PROCEDURE

Interventions

Radiation therapy

Intervention Type: RADIATION

Temozolomide

Intervention Type: DRUG

Stem cell collection

Intervention Type: PROCEDURE

Stem cell infusion

Intervention Type: PROCEDURE

Other Intervention Names

Temodar®

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jian Li Campian, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

15-x135

Identifier Type: -

Identifier Source: org_study_id