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Home > "P" Clinical Trials Conditions > Pyrazoloacridine Plus Carboplatin in Treating Patients With Recurrent Glioma  Pyrazoloacridine Plus Carboplatin in Treating Patients With Recurrent Glioma
Pyrazoloacridine Plus Carboplatin in Treating Patients With Recurrent Glioma
For Condition: adult brain tumor,adult infiltrating astrocytoma,Mixed Gliomas,Adult Oligodendroglioma
Status: No longer recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of pyrazoloacridine plus carboplatin in treating patients who have recurrent glioma.
Details: OBJECTIVES: - Determine the maximum tolerated dose of pyrazoloacridine plus carboplatin in patients with recurrent glioma. - Determine the toxic effects of this treatment regimen in these patients. - Determine the safety of this treatment regimen at the recommended phase II dose in patients not receiving anticonvulsants. - Determine the efficacy of this treatment regimen in these patients. - Assess the pharmacokinetics and metabolism of pyrazoloacridine in these patients. - Assess the response rate, time to progression, and time to death in patients treated with this regimen. OUTLINE: This is a three-part, dose-escalation, multicenter study. Patients in study 3 are stratified according to concurrent anticonvulsants (yes vs no). - (Study 1 closed as of 03/29/02) Patients receive carboplatin IV over 30 minutes and pyrazoloacridine IV over 3 hours on day 1. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of carboplatin and pyrazoloacridine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. - Study 2: (Study 2 closed as of 03/29/02) Patients receive the same treatment as given in study 1. Dose escalation is performed as in study 1 to determine the MTD in patients not receiving concurrent anticonvulsants. - Study 3: Patients receive the same treatment as given in studies 1 and 2 without dose escalation. Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years. PROJECTED ACCRUAL: Study 1: (Study 1 closed as of 03/29/02) - A total of 3-21 patients will be accrued for this study within 6-20 months. Study 2: (Study 2 closed as of 03/29/02) - A total of 3-12 patients will be accrued for this study within 3-18 months. Study 3: - A total of 12-37 patients will be accrued for this study within 15 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed primary brain glioma - Diffuse astrocytoma - Gliosarcoma - Oligodendroglioma - Oligoastrocytoma - Progressive disease after radiotherapy - Measurable or evaluable disease by MRI or CT PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic: - Bilirubin no greater than upper limit of normal (ULN) - SGOT no greater than 2.5 times ULN Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No myocardial infarction within the past 6 months - No congestive heart failure requiring therapy Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No uncontrolled infection - No other active malignancy - No other concurrent severe disease PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) - No more than 1 prior adjuvant chemotherapy regimen - No prior polifeprosan 20 with carmustine implant (Gliadel wafer) - Study 3 only: - 1 prior chemotherapy regimen for recurrent disease allowed - Prior nonplatinum-containing adjuvant chemotherapy allowed - Prior platinum-containing adjuvant chemotherapy allowed if disease progressed at least 6 months after last treatment Endocrine therapy: - Non-increasing dose of corticosteroids for at least 1 week allowed Radiotherapy: - See Disease Characteristics - At least 12 weeks since prior radiotherapy - No prior stereotactic radiosurgery or interstitial brachytherapy unless at least one lesion outside of irradiated area Surgery: - No surgical resection since prior radiotherapy or chemotherapy unless evidence of disease progression or lesion outside of treatment site Other: - Study 1 only: (Study 1 closed as of 03/29/02) - Must be on anticonvulsants that can induce cytochrome P-450 (phenytoin, carbamazepine, barbiturates, or primidone) - Study 2 only: (Study 2 closed as of 03/29/02) - No concurrent anticonvulsants
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EvanthiaGalanis, Study Chair, Mayo Clinic Cancer Center
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Medcenter One Health System
Bismark, North Dakota, 58501-5505
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
CentraCare Health Plaza
St. Cloud, Minnesota, 56303
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Altru Cancer Center
Grand Forks, North Dakota, 58201
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43623-3456
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Additional Information:
Study ID Numbers: CDR0000067963; NCCTG-987254
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005976
Other Mixed Gliomas Studies:
1. Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma
2. Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma
3. O6-benzylguanine and Carmustine Implants in Treating Patients With Recurrent Malignant Glioma
4. Imatinib Mesylate in Treating Patients With Gliomas
5. Lonafarnib and Temozolomide in Treating Patients With Recurrent Primary Supratentorial Gliomas
Related Studies:
Other Mixed Gliomas Clinical Trials
Other Illinois Clinical Trials
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Pyrazoloacridine Plus Carboplatin in Treating Patients With Recurrent Glioma
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