Clinical trial · Interventional
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Brain Cancer
Dose Escalation of Temozolomide in Combination With Thiotepa and Carboplatin With Autologous Stem Cell Rescue in Patients With Malignant Brain Tumors With Minimal Residual Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining temozolomide, thiotepa, and carboplatin followed by peripheral stem cell transplantation or bone marrow transplantation in treating patients who have brain cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous bone marrow transplantation | Procedure | — | UNRESOLVED |
| carboplatin | Drug | Carboplatin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
| thiotepa | Drug | Thiotepa | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 49 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of one of the following malignant brain tumors: * Anaplastic astrocytoma * Glioblastoma multiforme * Anaplastic oligodendroglioma * Medulloblastoma * High-grade ependymoma * Germ cell tumors * Pineoblastoma * Other primitive neuroectodermal tumors * Recurrent disease or resistant to conventional therapy (e.g., surgery, radiotherapy, or standard chemotherapy) * No prior myeloablative doses of thiotepa OR * Newly diagnosed malignant glioma with minimal residual disease after prior radiotherapy * Minimal residual disease is defined as tumor with maximum diameter of less than 1.5 cm by MRI and no corticosteroid dependency PATIENT CHARACTERISTICS: Age: * Over 1 to under 50 Performance status: * Karnofsky 70-100% OR * Lansky 70-100% Life expectancy: * More than 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * SGOT/SGPT less than 2.5 times ULN * Alkaline phosphatase less than 2.5 times ULN Renal: * Creatinine less than 1.5 times ULN * Creatinine clearance at least 70 mL/min * BUN less than 1.5 times ULN Cardiovascular: * Ejection fraction greater than 50% OR * Shortening fraction greater than 27% * No evidence of myocardial ischemia on EKG if over 40 years of age Other: * HIV negative * No AIDS-related illness * No frequent vomiting or medical condition that would preclude oral medication (e.g., partial bowel obstruction) * No other malignancy within the past 2 years except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 2 weeks since prior biologic therapy or immunotherapy Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: * See Disease Characteristics Radiotherapy: * See Disease Characteristics * At least 6 weeks since prior radiotherapy and recovered * At least 6 weeks since prior brachytherapy or radiosurgery Surgery: * See Disease Characteristics * Recovered from prior major surgery
References
Publications (0)
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