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

NCT02976441 | Withdrawn Early Phase 1

• 1 other identifier: 15-x135
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (6)

• 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)

• Changes in series of cytokine levels following collection and reinfusion

  Up to 6 months after stem cell reinfusion (approximately 9 months)

Study Arms (1)

Focal RT, Temozolomide, Stem Cell Collection/Reinfusion

EXPERIMENTAL

* 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; Procedure: Stem cell collection; Procedure: Stem cell infusion

Interventions

Radiation therapy RADIATION

Focal RT, Temozolomide, Stem Cell Collection/Reinfusion

Temozolomide DRUG

Also known as: Temodar®

Focal RT, Temozolomide, Stem Cell Collection/Reinfusion

Stem cell collection PROCEDURE

Focal RT, Temozolomide, Stem Cell Collection/Reinfusion

Stem cell infusion PROCEDURE

Focal RT, Temozolomide, Stem Cell Collection/Reinfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Related Links

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

MeSH Terms

Conditions

Astrocytoma; Ependymoma; Glioma; Oligodendroglioma; Optic Nerve Glioma

Interventions

Radiotherapy; Temozolomide

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Optic Nerve Neoplasms; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Optic Nerve Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jian Li Campian, M.D., Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: November 29, 2016
• Study Start: January 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: February 20, 2017

Record last verified: 2017-02