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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

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Trial Information

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


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.

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

- SGOT or SGPT no greater than 2 times normal

Renal:

- 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Roy A. Patchell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Lucille P. Markey Cancer Center at University of Kentucky

Authority:

United States: Federal Government

Study ID:

CDR0000068343

NCT ID:

NCT00006916

Start Date:

June 2001

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Dixie Regional Medical CenterSaint George, Utah  84770
LDS HospitalSalt Lake City, Utah  84143
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Foundation for Cancer Research and EducationPhoenix, Arizona  85013
South Jersey Regional Cancer CenterMillville, New Jersey  08332
St. John Health SystemTulsa, Oklahoma  74104
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Fox Chase Virtua Health Cancer Program at Virtua Memorial HospitalMount Holly, New Jersey  08060
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - OmahaOmaha, Nebraska  68114-4199
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
Cottonwood Hospital Medical CenterMurray, Utah  84107
Cancer Treatment CenterWooster, Ohio  44691