Clinical trial NCT02976441: Autologous Stem Cell Collection and Reinfusion in Newly Diagnosed High Grade Gliomas
Official title: Feasibility of Autologous Stem Cell Collection and Reinfusion in Newly Diagnosed High Grade Gliomas
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Astrocytoma
Brainstem Glioma
Ependymoma
Mixed Glioma
Oligodendroglioma
Optic Nerve Glioma
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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
timeFrame: Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months)
Secondary outcomes:
measure: Number of lymphocyte stem cells that can be harvested from this patient population
timeFrame: Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months)
measure: Proportion of patients who have an increase in lymphocyte of ≥300 cells/mm^3 after autologous stem cell reinfusion.
timeFrame: 4 weeks after stem cell reinfusion
measure: Duration of lymphocyte rise following stem cell reinfusion
timeFrame: Up to 6 months after stem cell reinfusion (approximately 9 months)
measure: Changes in lymphocyte subtypes following collection and reinfusion
timeFrame: Up to 6 months after stem cell reinfusion (approximately 9 months)
measure: Changes in series of cytokine levels following collection and reinfusion
timeFrame: Up to 6 months after stem cell reinfusion (approximately 9 months)
measure: Safety and toxicities with stem cell collection and reinfusion as measured by grade and frequency of adverse events
timeFrame: Up to 6 months after stem cell reinfusion (approximately 9 months)
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Jian Li Campian, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: