Clinical trial · Interventional
Efaproxiral Plus Carmustine in Treating Patients With Progressive or Recurrent Malignant Glioma
A Phase I/II Study to Evaluate the Safety and Tolerance of Escalating Doses of RSR13 Administered With a Fixed Dose of BCNU Every Six Weeks in Patients With Recurrent Malignant Glioma
- 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. Combining more than one drug may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of efaproxiral when given with carmustine and to see how well they work in treating patients with progressive or recurrent 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carmustine | Drug | Carmustine | ALIAS |
| efaproxiral | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Safety and tolerability
- measure
- Maximum tolerated dose
- measure
- Pharmacokinetic profile
- measure
- Efficacy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed malignant glioma that is progressive or recurrent after radiotherapy with or without chemotherapy * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Glioblastoma multiforme * Prior low-grade glioma allowed provided progression has occurred after radiotherapy with or without chemotherapy and then high-grade glioma is found on biopsy * Measurable disease by serial MRI or CT scan PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Hemoglobin at least 10 g/dL * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2.0 mg/dL * Alkaline phosphatase no greater than 3 times upper limit of normal (ULN) * SGOT and SGPT no greater than 3 times ULN Renal: * Creatinine no greater than 2.0 mg/dL Pulmonary: * Resting oxygen saturation on room air at least 90% by pulse oximetry * FVC, DLCO, and FEV\_1 at least 50% of normal Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other serious concurrent medical illness that would preclude study compliance * No other prior malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior investigational biologics Chemotherapy: * See Disease Characteristics * No prior nitrosoureas for glioma * No more than 1 prior chemotherapy regimen * At least 4 weeks since prior chemotherapy * No prior efaproxiral Endocrine therapy: * Concurrent corticosteroids (e.g., dexamethasone) allowed Radiotherapy: * See Disease Characteristics * At least 90 days since prior radiotherapy Surgery: * Not specified Other: * At least 3 weeks since other prior investigational drugs or devices
References
Publications (0)
Data not yet available