Radiation Therapy Followed by Bleomycin in Treating Adult Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme

NCT00006916 | Terminated Phase 2 Results DMC

• 2 other identifiers: RTOG-BR-0013CDR0000068343
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 13

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.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  This study stopped accrual early with 19 subjects accrued out of 72 planned therefore no analyses were performed.

  From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.

Study Arms (1)

Radiation therapy followed by bleomycin via Ommaya reservoir

EXPERIMENTAL

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.

Biological: bleomycin; Device: Ommaya reservoir; Radiation: radiation therapy

Interventions

bleomycin BIOLOGICAL

Radiation therapy followed by bleomycin via Ommaya reservoir

Ommaya reservoir DEVICE

Radiation therapy followed by bleomycin via Ommaya reservoir

radiation therapy RADIATION

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.

Radiation therapy followed by bleomycin via Ommaya reservoir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (13)

Foundation for Cancer Research and Education

Phoenix, Arizona, 85013, United States

Location

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536-0293, United States

Location

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha

Omaha, Nebraska, 68114-4199, United States

Location

South Jersey Regional Cancer Center

Millville, New Jersey, 08332, United States

Location

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital

Mount Holly, New Jersey, 08060, United States

Location

Cancer Treatment Center

Wooster, Ohio, 44691, United States

Location

St. John Health System

Tulsa, Oklahoma, 74104, United States

Location

Cottonwood Hospital Medical Center

Murray, Utah, 84107, United States

Location

Utah Valley Regional Medical Center - Provo

Provo, Utah, 84604, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Dixie Regional Medical Center

St. George, Utah, 84770, United States

Location

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Glioblastoma; Gliosarcoma

Interventions

Bleomycin; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Therapeutics

Limitations and Caveats

This study stopped accrual early due unmet targeted accrual goals with 19 subjects accrued out of 72 planned. No efficacy analyses were performed since the small number of patients would not have provided meaningful results.

Results Point of Contact

• Title: Wendy Seiferheld
• Organization: Radiation Therapy Oncology Group (RTOG)

wseiferheld@acr.org

Study Officials

• Roy A. Patchell, MD

  Lucille P. Markey Cancer Center at University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2000
• First Posted: January 27, 2003
• Study Start: June 1, 2001
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: October 26, 2020
• Results First Posted: February 3, 2014

Record last verified: 2015-11

Locations

US (13)