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Home > "A" Clinical Trials Conditions > Arsenic Trioxide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma  Arsenic Trioxide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma
Arsenic Trioxide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma
For Condition: adult glioblastoma multiforme
Status: Suspended
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 trial to study the effectiveness of combining arsenic trioxide with radiation therapy in treating patients who have newly diagnosed malignant glioma.
Details: OBJECTIVES: - Determine the maximum tolerated dose of arsenic trioxide in combination with radiotherapy in patients with newly diagnosed malignant glioma. - Determine the toxicity of this regimen in these patients. - Determine the survival of patients treated with this regimen. - Evaluate the effect of arsenic trioxide on tumor vasculature in these patients. - Determine the pharmacokinetics of arsenic trioxide in these patients. OUTLINE: This is a multicenter, dose-escalation study of arsenic trioxide. Patients receive arsenic trioxide IV over 2 hours once weekly for 6 weeks. Patients also undergo radiotherapy once daily 5 days a week for 6 weeks. Cohorts of 3-6 patients receive escalating doses of arsenic trioxide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 3 of 6 patients experience dose-limiting toxicity. Patients are followed weekly for 4 weeks and then every 2 months thereafter. PROJECTED ACCRUAL: Approximately 18-30 patients will be accrued for this study within 6-15 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) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic - Bilirubin less than 2 mg/dL - AST/ALT less than 2.5 times upper limit of normal Renal - Creatinine no greater than 1.5 mg/dL - Potassium greater than 3.0 mEq/L and less than 5.5 mEq/L - Magnesium greater than 1.2 mEq/L and less than 2.5 mEq/L Cardiovascular - No second-degree heart block Other - Mini mental score at least 15 - Able to undergo MRI - No serious concurrent infection - No other medical illness that would preclude study - No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 2 months after study PRIOR CONCURRENT THERAPY: Biologic therapy - No prior immunotherapy or biologic therapy for this disease (e.g., immunotoxins, immunoconjugates, antisense therapy, peptide receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocytes, lymphokine-activated killer cell therapy, or gene therapy) Chemotherapy - No prior chemotherapy for this disease Endocrine therapy - No prior hormonal therapy for this disease - Prior glucocorticoid therapy allowed - Must be on a stable corticosteroid regimen (i.e., no increase for 5 days) Radiotherapy - No prior radiotherapy for this disease Surgery - Prior surgery allowed - Recovered from prior surgery Other - At least 5 days since prior drugs that are known to prolong QT interval - No other prior therapy for this disease - No concurrent amphotericin B - No drugs that are known to prolong QT interval during or for 2 weeks after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SamuelRyu, Study Chair, Henry Ford Hospital
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1030
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Additional Information:
Study ID Numbers: CDR0000256614; NABTT-2115,JHOC-NABTT-2115
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045565
Other Adult Glioblastoma Multiforme Studies:
1. ZD 1839 in Treating Patients With Glioblastoma Multiforme in First Relapse
2. Irinotecan in Treating Patients With Recurrent Malignant Glioma
3. Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
4. Arsenic Trioxide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma
5. CCI-779 in Treating Patients With Malignant Glioma
Related Studies:
Other adult glioblastoma multiforme Clinical Trials
Other Alabama Clinical Trials
Other Birmingham Clinical Trials
Arsenic Trioxide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma
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