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Home > "M" Clinical Trials Conditions > Motexafin Gadolinium Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme  Motexafin Gadolinium Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Motexafin Gadolinium Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
For Condition: adult glioblastoma multiforme
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Jonsson Comprehensive Cancer Center
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Motexafin gadolinium may increase the effectiveness of radiation therapy by making tumor cells more sensitive to radiation. PURPOSE: Phase I trial to study the effectiveness of motexafin gadolinium plus radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.
Details: OBJECTIVES: I. Determine the safety and tolerability of motexafin gadolinium in combination with radiotherapy in patients with newly diagnosed glioblastoma multiforme. II. Determine the intratumoral pharmacology and quantitative pharmacokinetics of this drug in this patient population. PROTOCOL OUTLINE: This is a multicenter, dose-escalation study of motexafin gadolinium. Patients receive a loading dose regimen comprising motexafin gadolinium IV over 10-15 minutes on days 1-5 or days 1-5 and 8-12 (cohort 7). After the loading dose regimen, patients receive a maintenance regimen comprising motexafin gadolinium IV 3 times weekly for a maximum of 6.5 weeks. Patients also undergo radiotherapy once daily, 5 days a week, for 6.5 weeks. Cohorts of 3-6 patients receive an escalating number of doses of motexafin gadolinium 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. Patients are followed at 4 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A maximum of 35 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed newly diagnosed glioblastoma multiforme requiring radical radiotherapy - No anaplastic astrocytoma or low-grade astrocytoma - Able to start radiotherapy within 5 weeks of definitive surgery (unless delay due to cause other than medical illness or poor performance status) --Prior/Concurrent Therapy-- - Biologic therapy: No biologic therapy for at least 4 weeks after study completion; No immunotherapy for at least 4 weeks after study completion - Chemotherapy: No chemotherapy for at least 4 weeks after study completion - Endocrine therapy: Concurrent steroids allowed - Radiotherapy: See Disease Characteristics; No prior radiotherapy for this disease or other brain tumor; No prior radiotherapy to face, head, or neck - Surgery: See Disease Characteristics; Recovered from prior surgery or postoperative complication - Other: At least 48 hours since prior MRI scan with contrast; No concurrent MRI scans with contrast; No other concurrent experimental drug --Patient Characteristics-- - Age: 18 and over - Performance status: See Disease Characteristics; Karnofsky 60-100% - Life expectancy: Not specified - Hematopoietic: WBC at least 3,000/mm3; Granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: AST and ALT no greater than 2 times upper limit of normal (ULN); Bilirubin no greater than 2 mg/dL PT and aPTT no greater than 1.5 times ULN - Renal: Creatinine less than 1.5 mg/dL - Cardiovascular: No severe cardiac disease - Pulmonary: No severe lung disease - Other: No other significant life-threatening disease; No other active malignancy; No known glucose-6-phosphate dehydrogenase deficiency; No known porphyria; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JudithFord, Study Chair, Jonsson Comprehensive Cancer Center
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000066421; UCLA-HSPC-970904203,NCI-T97-0108,COOPER-RP-97-126,LAC-USC-6G971,UCD-RW-98-01,UCLA-HSPC-970904201,UCLA-HSPC-970904202
Study Start Date: October 2001
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003409
Other Adult Glioblastoma Multiforme Studies:
1. Tipifarnib in Treating Patients With Recurrent or Progressive Malignant Glioma
2. Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma
3. Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
4. BMS 247550 in Treating Patients With Recurrent Glioma
5. Carmustine in Treating Patients With Recurrent Malignant Glioma
Related Studies:
Other adult glioblastoma multiforme Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Motexafin Gadolinium Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
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