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Home > "T" Clinical Trials Conditions > Tipifarnib and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme  Tipifarnib and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Tipifarnib and 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: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining tipifarnib with radiation therapy may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining tipifarnib with radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.
Details: OBJECTIVES: - Determine the progression-free and overall survival of patients with newly diagnosed glioblastoma multiforme treated with tipifarnib and radiotherapy. - Determine the response rate of patients treated with this regimen. - Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. - Induction therapy: Patients receive oral tipifarnib twice daily for 3 weeks. Treatment repeats every 4 weeks for up to 3 courses. - Radiotherapy: Within 14 days after the completion of induction therapy, patients undergo radiotherapy daily, 5 days a week, for 6 weeks. - Maintenance therapy: Two weeks after the completion of radiotherapy, patients receive additional tipifarnib as in induction therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months. PROJECTED ACCRUAL: A minimum of 54 patients will be accrued for this study within 11-14 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 - Measurable and contrast-enhancing tumor on the postoperative 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 g/dL Hepatic - Bilirubin no greater than 2.0 mg/dL - AST/ALT no greater than 4 times upper limit of normal Renal - Creatinine no greater than 1.5 mg/dL Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Mini-mental state exam score at least 15 - No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast - No serious concurrent infection that would preclude study therapy - No other medical illness that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy - No prior immunotherapy for brain tumor - No prior biologic therapy for brain tumor, including any of the following: - Immunotoxins - Immunoconjugates - Antisense therapy - Peptide receptor antagonists - Interferons - Interleukins - Tumor-infiltrating lymphocytes - Lymphokine-activated killer cell therapy - Gene therapy Chemotherapy - No prior chemotherapy for brain tumor - No prior polifeprosan 20 with carmustine implant (Gliadel wafer) Endocrine therapy - No prior hormonal therapy (except glucocorticoids) for brain tumor - Must be maintained on a stable corticosteroid regimen prior to study entry Radiotherapy - No prior radiotherapy for brain tumor Surgery - See Disease Characteristics - Recovered from prior surgery Other - At least 10 days since prior hepatic metabolic enzyme-inducing anticonvulsant drugs, including the following: - Phenytoin - Carbamazepine - Phenobarbital - Primidone - Oxcarbazepine - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertLustig, Study Chair, University of Pennsylvania Cancer Center
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Kevin Judy 215-662-7854
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231-2410
United States
Recruiting Larry Kleinberg 410-614-2597
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting David Peereboom 216-445-6068
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Louis Nabors 205-934-1432
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1030
United States
Recruiting Edward Shaw 336-716-4647
Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Mark Rosenblum 313-916-1340
Massachusetts General Hospital Cancer Center *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Alison O'Neill 617-726-2000
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Ian Crocker 404-778-3473
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting James Pearlman 813-972-8424
Additional Information:
Study ID Numbers: CDR0000285732; NABTT-2200,JHOC-NABTT-2200
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058097
Other Adult Glioblastoma Multiforme Studies:
1. Topotecan and Thalidomide in Treating Patients With Recurrent or Refractory Malignant Glioma
2. Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
3. Irinotecan in Treating Patients With Recurrent Malignant Glioma
4. Radiation Therapy Followed by Carmustine in Treating Patients Who Have Supratentorial Glioblastoma Multiforme
5. Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas
Related Studies:
Other adult glioblastoma multiforme Clinical Trials
Other Florida Clinical Trials
Other Tampa Clinical Trials
Tipifarnib and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
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