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

Information source: Radiation Therapy Oncology Group
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain and Central Nervous System Tumors

Intervention: bleomycin (Biological); Ommaya reservoir (Device); radiation therapy (Radiation)

Phase: Phase 2

Status: Terminated

Sponsored by: Radiation Therapy Oncology Group

Official(s) and/or principal investigator(s):
Roy A. Patchell, MD, Principal Investigator, Affiliation: Lucille P. Markey Cancer Center at University of Kentucky

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.

Clinical Details

Official title: 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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall Survival

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Foundation for Cancer Research and Education, Phoenix, Arizona 85013, United States

Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky 40536-0293, United States

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha, Omaha, Nebraska 68114-4199, United States

South Jersey Regional Cancer Center, Millville, New Jersey 08332, United States

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital, Mount Holly, New Jersey 08060, United States

Cancer Treatment Center, Wooster, Ohio 44691, United States

St. John Health System, Tulsa, Oklahoma 74104, United States

Cottonwood Hospital Medical Center, Murray, Utah 84107, United States

Utah Valley Regional Medical Center - Provo, Provo, Utah 84604, United States

Dixie Regional Medical Center, Saint George, Utah 84770, United States

LDS Hospital, Salt Lake City, Utah 84143, United States

CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin 54449, United States

Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: June 2001
Last updated: April 30, 2014

Page last updated: August 20, 2015

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