Clinical trial · Interventional
Radiation Therapy Followed by Bleomycin in Treating Adult Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
A Phase II Trial Of Conventional Radiation Therapy Followed By Intratumoral Bleomycin Delivered Using A Refillable, Sustained Release Device (IND# 46,592) For The Treatment Of Supratentorial Glioblastoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by bleomycin in treating adult patients who have newly diagnosed supratentorial glioblastoma multiforme.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bleomycin | Biological | Bleomycin | ALIAS |
| Ommaya reservoir | Device | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation therapy followed by bleomycin via Ommaya reservoir
- description
- 60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
- interventionNames
- Biological: bleomycin
- Device: Ommaya reservoir
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.
- description
- This study stopped accrual early with 19 subjects accrued out of 72 planned therefore no analyses were performed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed supratentorial glioblastoma multiforme (with areas of necrosis) by surgical biopsy or excision within 4 weeks of study * Tumor and/or any associated edema limited to one hemisphere and unifocal * No gross invasion of a ventricular surface * Tumor accessible * No other astrocytoma * No multifocal or recurrent malignant glioma * No disease below the tentorium or beyond the cranial vault PATIENT CHARACTERISTICS: Age: * Adult Performance status: * Zubrod 0-1 Life expectancy: * At least 8 weeks Hematopoietic: * Hemoglobin at least 10 g/dL (transfusion allowed) * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2.0 mg/dL * Serum glutamic-oxaloacetic transaminase (SGOT) or Serum glutamic-pyruvic transaminase (SGPT) no greater than 2 times normal Renal: * Blood Urea Nitrogen (BUN) no greater than 25 mg/dL * Creatinine no greater than 1.5 mg/dL Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No hypersensitive or idiosyncratic reaction to bleomycin * No other prior malignancies within the past 2 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix or urinary bladder * No other major medical illness or psychiatric impairment that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for glioblastoma multiforme * No prior radiosensitizer for glioblastoma multiforme Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to the head or neck resulting in overlapping radiotherapy fields Surgery: * See Disease Characteristics * Recovered from prior surgery
References
Publications (0)
Data not yet available