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Home > "O" Clinical Trials Conditions > Oxaliplatin Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme  Oxaliplatin Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Oxaliplatin Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
For Condition: adult glioblastoma multiforme
Status: Recruiting
Sponsor(s): 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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of oxaliplatin followed by radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.
Details: OBJECTIVES: - Determine the maximum tolerated dose of oxaliplatin administered prior to radiotherapy in patients with newly diagnosed glioblastoma multiforme who are receiving or not receiving anticonvulsants known to be metabolized by P450. - Determine the dose-limiting toxicity and safety profile of neoadjuvant oxaliplatin in this patient population. - Assess the pharmacokinetics of this drug on this schedule and determine the effects of P450-inducing anticonvulsants on the pharmacokinetics in these patients. - Determine the radiographic response rate of patients treated with this regimen. - Determine time to radiographic progression, survival, and drug toxicity in patients treated with this regimen. OUTLINE: This is a dose-escalation study of oxaliplatin. Patients are stratified according to whether concurrent anticonvulsant drugs induce P450 (yes vs modest/no or no drugs). Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Beginning 14-28 days after completion of chemotherapy, patients receive radiotherapy daily 5 days a week for 6 weeks. Patients who develop progressive disease prior to completion of chemotherapy are removed from study and then proceed immediately to radiotherapy. Cohorts of 3-6 patients (per stratum) receive escalating doses of oxaliplatin 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. Once the MTD is determined, additional patients are accrued to receive treatment with oxaliplatin at the recommended phase II dose. Patients are followed at 1 month, every 2 months until post-radiotherapy progression, and then monthly thereafter. PROJECTED ACCRUAL: Approximately 24 patients (12 per stratum) will be accrued for the phase I part of this study within 8-12 months. A total of 18-35 patients will be accrued for the phase II part of this study within 5-12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed supratentorial grade IV astrocytoma - Glioblastoma multiforme - Subtotal resection or biopsy with measurable and contrast-enhancing disease on the postoperative, pretreatment MRI/CT scan PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% 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 9.0 g/dL Hepatic: - Bilirubin normal Renal: - Creatinine normal OR - Creatinine clearance at least 60 mL/min Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No serious concurrent infection or medical illness that would jeopardize ability to receive protocol chemotherapy with reasonable safety - No other prior malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer - No grade 2 or greater pre-existing sensory neuropathy - No history of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol chemotherapy - Mini mental score at least 15 PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior immunotherapy for glioblastoma multiforme - No prior biologic therapy for glioblastoma multiforme, including: - Immunotoxins - Immunoconjugates - Antiangiogenesis compounds - Antisense - Peptide receptor antagonists - Interferons - Interleukins - Tumor infiltrating lymphocytes - Lymphokine activated killer cells - Gene therapy - No concurrent filgrastim (G-CSF) Chemotherapy: - No prior chemotherapy for glioblastoma multiforme Endocrine therapy: - No prior hormonal therapy for glioblastoma multiforme - Prior glucocorticoid therapy for glioblastoma multiforme allowed - Must be maintained on a stable (lowest required dose) corticosteroid regimen for at least 5 days before and during study - No concurrent dexamethasone as an antiemetic Radiotherapy: - No prior radiotherapy for glioblastoma multiforme Surgery: - See Disease Characteristics - Recovered from immediate postoperative period Other: - At least 10 days since prior anticonvulsant drug that induces hepatic metabolic enzymes - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TracyBatchelor, Study Chair, Massachusetts General Hospital
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3295
United States
Recruiting James Markert 205-975-6985
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Gene Barnett 216-444-1379
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78284-7811
United States
Recruiting Pamela New 210-617-5161
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting David Kelly 336-716-4049
Massachusetts General Hospital Cancer Center *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting E. Chiocca 617-726-3779
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting David Lawson 404-778-4189
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231-2410
United States
Recruiting Larry Kleinberg 410-614-2597
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting James Pearlman 813-972-8424
Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Jae Kim 313-916-1029
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Jane Alavi 215-662-6319
Additional Information:
Study ID Numbers: CDR0000067883; JHOC-NABTT-9902,NABTT-9902
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005856
Other Adult Glioblastoma Multiforme Studies:
1. Tipifarnib and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
2. Erlotinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme
3. Irinotecan Plus Radiation Therapy Followed By Chemotherapy in Treating Patients With Glioblastoma Multiforme
4. Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme
5. Pyrazoloacridine Followed by Radiation Therapy in Treating Adults With Newly Diagnosed Supratentorial Glioblastoma Multiforme
Related Studies:
Other adult glioblastoma multiforme Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Oxaliplatin Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
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