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Home > "Z" Clinical Trials Conditions > ZD 1839 in Treating Patients With Newly Diagnosed Glioblastoma Multiforme  ZD 1839 in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
ZD 1839 in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
For Condition: adult glioblastoma multiforme
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , North Central Cancer Treatment Group
Synopsis: RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of glioblastoma multiforme . PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have newly diagnosed glioblastoma multiforme.
Details: OBJECTIVES: I. Determine treatment effectiveness of ZD 1839, in terms of response rate, time to progression, survival at 52 weeks, progression-free survival at 6 months, and overall survival, in patients with newly diagnosed glioblastoma multiforme. II. Determine the toxic effects of this drug in these patients. III. Assess fatigue, depression, excessive daytime somnolence, and quality of life in patients treated with this drug. IV. Assess individual variation in responses, pharmacokinetic parameters, and/or biological correlates due to genetic differences in enzymes involved in transport, metabolism, and/or mechanism of action of this drug in these patients. V. Determine if the type of epidermal growth factor receptor affects tumor response and outcome in patients treated with this drug. PROTOCOL OUTLINE: This is a multicenter study. Patients receive oral ZD 1839 daily. Courses repeat every 8 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, before each treatment course, every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years. Patients are followed every 8 weeks until tumor progression. Patients removed from study treatment for reasons other than disease progression are followed every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study within 14 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed newly diagnosed WHO grade IV astrocytoma (glioblastoma multiforme) or gliosarcoma - No WHO grade III anaplastic astrocytoma, oligodendroglioma, or mixed oligoastrocytoma Within 2-5 weeks of completion of standard external beam radiotherapy - No evidence of tumor progression during radiotherapy --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: No prior chemotherapy (including polifeprosan 20 with carmustine implant) for this tumor Endocrine therapy: Not specified Radiotherapy: - See Disease Characteristics - No prior stereotactic radiosurgery or interstitial brachytherapy Surgery: No more than 15 weeks since prior surgery --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 - Hemoglobin at least 10.0 g/dL Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST no greater than 3 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: - No other active malignancy - No uncontrolled infection - No other severe concurrent disease that would preclude study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JoonUhm, Study Chair, North Central Cancer Treatment Group
Mayo Clinic
Jacksonville, Florida, 32224
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772
United States
Altru Health Systems
Grand Forks, North Dakota, 58201
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
Medcenter One Health System
Bismark, North Dakota, 58501
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
CentraCare Health Plaza
St. Cloud, Minnesota, 56303
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Additional Information:
Study ID Numbers: CDR0000068511; NCCTG-N0074
Study Start Date: March 2001
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014170
Other Adult Glioblastoma Multiforme Studies:
1. Temozolomide in Treating Patients With Recurrent Malignant Glioma
2. Temozolomide and O6-benzylguanine in Treating Patients With Newly Diagnosed, Recurrent, or Progressive Anaplastic Glioma
3. Radiation Therapy Followed by Carmustine in Treating Patients Who Have Supratentorial Glioblastoma Multiforme
4. O(6)-benzylguanine in Treating Patients With Malignant Glioma
5. Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma
Related Studies:
Other adult glioblastoma multiforme Clinical Trials
Other Saskatchewan Clinical Trials
Other Regina Clinical Trials
ZD 1839 in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
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