Brain and Central Nervous System Tumors
Conditions
Keywords
adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
Brief summary
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.
Detailed description
OBJECTIVES: * Determine the median survival time of patients with newly diagnosed supratentorial glioblastoma multiforme treated with radiotherapy followed by sustained release intratumoral bleomycin. * Determine the feasibility of this regimen in these patients. OUTLINE: This is a multicenter study. Within 4 weeks after surgical resection, patients receive radiotherapy daily 5 days a week for 6 weeks. Within 2-6 weeks after completion of radiotherapy or at disease progression during radiotherapy, patients undergo surgical implantation of a modified Ommaya reservoir within the central area of the tumor. Patients then receive sustained release bleomycin intratumorally via the reservoir once a week for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 5 months.
Interventions
BIOLOGICALbleomycin
DEVICEOmmaya reservoir
RADIATIONradiation therapy
60.0 Gy/30 fractions x 2.0 Gy. For the first 46 Gy/23 fractions the treatment volume should include the volume of contrast-enhancing lesion and surrounding edema on pre-operative CT/MRI scan plus a 2 centimeter margin. If no edema is present, the margin should be 2.5 cm. After 46.0 Gy, the tumor volume should include the contrast-enhancing lesion (without edema) on the pre-surgery MRI/CT scan plus a 2.5 centimeter margin.
Sponsors
National Cancer Institute (NCI)
Radiation Therapy Oncology Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months. | This study stopped accrual early with 19 subjects accrued out of 72 planned therefore no analyses were performed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir 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. | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Complication of device insertion | 1 |
| Overall Study | Device not inserted | 4 |
Baseline characteristics
| Characteristic | Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir |
|---|---|
| Age, Continuous | 59 years |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 17 / 19 |
| serious Total, serious adverse events | 5 / 19 |
Outcome results
Primary
Overall Survival
This study stopped accrual early with 19 subjects accrued out of 72 planned therefore no analyses were performed.
Time frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.