Clinical trial · Interventional
Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Malignant Glioma
CAMP 013:- Tandem Thiotepa Regimen For Selected Malignant Gliomas:1) Primary Or Recurrent Glioblastoma Multiforme (GBM); and 2) Recurrent Anaplastic Astrocytomas (AA), Oligodendrogliomas (O), Oligoastrocytomas (OA), Ependymomas And Primitive Neuroectodermal Tumors (PNET) That Have Either Progressed After Primary Therapy Or Are Refractory To Standard Chemotherapy
- 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 work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy with peripheral stem cell or bone marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This phase II trial is studying how well thiotepa followed by peripheral stem cell or bone marrow transplant works in treating patients with malignant glioma.
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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous bone marrow transplantation | Procedure | — | UNRESOLVED |
| bone marrow ablation with stem cell support | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
| thiotepa | Drug | Thiotepa | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Response rate
- measure
- Disease-free interval
- measure
- Overall survival
- measure
- Toxicity
Secondary outcomes (2)
- measure
- Pharmacokinetics
- measure
- Presence of high-dose thiotepa in the cerebrospinal fluid
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed malignant glioma * Primary or recurrent glioblastoma multiforme (including gliosarcoma) following surgery and radiotherapy or prior conventional chemotherapy (e.g., carmustine or procarbazine, vincristine, and lomustine) * Recurrent or refractory anaplastic astrocytoma following any prior therapy (must be chemoresistant) * Recurrent or refractory ependymoma or primitive neuroectodermal tumor (PNET) following any prior therapy * Recurrent or refractory oligodendroglioma or oligoastrocytoma following any prior therapy (must be chemoresistant) * Evaluable disease on gadolinium-enhanced MRI * Ineligible for other high priority national or institutional study (e.g., protocol CAMP-004) PATIENT CHARACTERISTICS: Age: * Any age Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Creatinine less than 1.5 times normal Cardiovascular: * LVEF at least 45% by MUGA Pulmonary: * DLCO at least 60% of predicted OR * Approval by pulmonologist Other: * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * No other concurrent chemotherapy Endocrine therapy: * No concurrent anticancer hormonal therapy * No concurrent steroids as antiemetics Radiotherapy: * See Disease Characteristics * See Surgery Surgery: * See Disease Characteristics * For patients with glioblastoma multiforme, concurrent surgery and/or stereotactic radiosurgery to reduce tumor bulk allowed Other: * No concurrent acetaminophen during chemotherapy
References
Publications (0)
Data not yet available