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Home > "R" Clinical Trials Conditions > Radiation Therapy Followed by Bleomycin in Treating Adult Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme

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



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

For Condition: adult glioblastoma multiforme
Status: Recruiting
Sponsor(s): Radiation Therapy Oncology Group , National Cancer Institute (NCI)
Synopsis: 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 supratentorialglioblastoma multiforme.
Details: 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
RoyPatchell,  Study Chair,  Markey Cancer Center at University of Kentucky Chandler Medical Center

CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield,  Wisconsin,  54449
United States
Recruiting Tarit  Banerjee 715-387-5134

Utah Valley Regional Medical Center - Provo *Recruiting*
Provo,  Utah,  84604
United States
Recruiting Tarlton  Blair 801-373-7850 ext. 2480

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital *Recruiting*
Mount Holly,  New Jersey,  08060
United States
Recruiting Lemuel  Ariaratnam 609-261-7074

Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee,  Wisconsin,  53226
United States
Recruiting Elizabeth  Gore 414-805-4465

LDS Hospital *Recruiting*
Salt Lake City,  Utah,  84143
United States
Recruiting William  Sause 801-408-1146

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha *Recruiting*
Omaha,  Nebraska,  68114-4199
United States
Recruiting James  Wheeler 402-354-4104

South Jersey Regional Cancer Center *Recruiting*
Millville,  New Jersey,  08332
United States
Recruiting Joseph  Fanelle 856-293-2910

St. John Health System *Recruiting*
Tulsa,  Oklahoma,  74104
United States
Recruiting Diane  Heaton 918-744-2071

Dixie Regional Medical Center *Recruiting*
St. George,  Utah,  84770
United States
Recruiting Ray  Richards 801-688-4175

Foundation for Cancer Research and Education *Recruiting*
Phoenix,  Arizona,  85013
United States
Recruiting David  Brachman 602-274-4484

Cottonwood Hospital Medical Center *Recruiting*
Murray,  Utah,  84107
United States
Recruiting Contact  Person 801-314-5300

Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington,  Kentucky,  40536-0293
United States
Recruiting Mohammed  Mohiuddin 859-323-6489

Cancer Treatment Center *Recruiting*
Wooster,  Ohio,  44691
United States
Recruiting Contact  Person 330-375-4221


Additional Information:
Study ID Numbers:
  CDR0000068343;  RTOG-BR-0013,RTOG-DEV-1072
Study Start Date: 
Record last reviewed: September 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006916

Other Adult Glioblastoma Multiforme Studies:
1. EMD 121974 in Treating Patients With Progressive or Recurrent Glioma

2. Brachytherapy in Treating Patients With Recurrent Malignant Glioma

3. Gene Therapy in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme

4. Temozolomide and O6-benzylguanine in Treating Patients With Newly Diagnosed, Recurrent, or Progressive Anaplastic Glioma

5. Efaproxiral Plus Carmustine in Treating Patients With Progressive or Recurrent Malignant Glioma

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