Clinical trial · Interventional
Autologous Stem Cell Collection and Reinfusion in Newly Diagnosed High Grade Gliomas
Feasibility of Autologous Stem Cell Collection and Reinfusion in Newly Diagnosed High Grade Gliomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Physician decided not to go through with study
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytoma | Astrocytoma | CURATED_BROADER | 0.80 |
| Brainstem Glioma | Brain Stem Glioma | ALIAS | 0.90 |
| Ependymoma | Ependymoma | ONTOLOGY_EXACT | 0.90 |
| Mixed Glioma | Mixed Glioma | ONTOLOGY_EXACT | 0.90 |
| Oligodendroglioma | Oligodendroglioma | CURATED_BROADER | 0.80 |
| Optic Nerve Glioma | Optic Nerve Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation therapy | Radiation | — | UNRESOLVED |
| Stem cell collection | Procedure | — | UNRESOLVED |
| Stem cell infusion | Procedure | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Focal RT, Temozolomide, Stem Cell Collection/Reinfusion
- description
- * 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
- interventionNames
- Radiation: Radiation therapy
- Drug: Temozolomide
- Procedure: Stem cell collection
- Procedure: Stem cell infusion
Primary outcomes (1)
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available