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Motexafin Gadolinium in Treating Patients With Glioblastoma Multiforme Who Are Undergoing Radiation Therapy to the Brain



Motexafin Gadolinium in Treating Patients With Glioblastoma Multiforme Who Are Undergoing Radiation Therapy to the Brain

For Condition: adult glioblastoma multiforme
Status: Suspended
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as motexafin gadolinium may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I trial to study the effectiveness motexafin gadolinium in treating patients with glioblastoma multiforme who are undergoing radiation therapy to the brain.
Details: OBJECTIVES: - Determine the toxicity of 2 different schedules of motexafin gadolinium as a radiosensitizer in patients with glioblastoma multiforme receiving cranial radiotherapy. - Determine the maximum tolerated doses of this drug on these 2 schedules in these patients. - Determine the pharmacokinetic profile of this drug in these patients. - Determine the biodistribution of this drug in both neoplastic tissue and normal brain parenchyma in these patients. - Determine the effect and accumulation of this drug in both normal brain parenchyma and neoplastic tissue in these patients. - Correlate the effect and accumulation of this drug in both normal brain parenchyma and neoplastic tissue with the pharmacokinetics of this drug in these patients. OUTLINE: This is a multicenter, dose-escalation study of motexafin gadolinium (PCI-0120). Patients are sequentially assigned to 1 of 2 treatment groups. - Group I: Patients receive PCI-0120 IV over 30-60 minutes once every other day for 6 weeks. Patients concurrently undergo cranial radiotherapy once daily 5 days a week for 6 weeks. - Group II: Patients receive PCI-0120 IV over 30-60 minutes once daily concurrently during radiotherapy. Patients undergo cranial radiotherapy as in group I. Cohorts of 3-6 patients in each group receive escalating doses of PCI-0120 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 1 month and then every 2 months thereafter. PROJECTED ACCRUAL: Approximately 18-30 patients will be accrued for this study.
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 - Previously untreated disease - Measurable and contrast-enhancing tumor by MRI after incomplete resection/biopsy PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic: - Bilirubin no greater than 2.0 mg/dL - SGOT/SGPT no greater than 4 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 4 times ULN - PT/APTT normal Renal: - Creatinine no greater than 1.5 mg/dL Cardiovascular: - No uncontrolled hypertension Other: - Mini mental state exam score at least 15 - No history of glucose-6-phosphate dehydrogenase deficiency or porphyria - No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of the breast - No serious infection - No other medical illness that would preclude study participation - No allergy to MRI contrast (e.g., motexafin gadolinium) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for up to 2 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior biologic therapy or immunotherapy for this disease, 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 this disease Endocrine therapy: - Must be on a stable corticosteroid regimen (i.e., no increase within 5 days prior to treatment on this protocol) - No other prior hormonal therapy for this disease Radiotherapy: - No prior radiotherapy for this disease Surgery: - See Disease Characteristics - Recovered from prior surgery Other: - No other concurrent investigational agents
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JamesPearlman,  Study Chair,  H. Lee Moffitt Cancer Center and Research Institute

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore,  Maryland,  21231
United States
 


Additional Information:
Study ID Numbers:  CDR0000069257;  NABTT-2116,JHOC-NABTT-2116
Study Start Date: 
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032097

Other Adult Glioblastoma Multiforme Studies:
1. Neoadjuvant and Adjuvant Fenretinide Compared With Adjuvant Fenretinide Alone in Treating Patients Who Are Undergoing Surgical Resection For Recurrent Glioblastoma Multiforme

2. Gadolinium Texaphyrin Plus Radiation Therapy in Treating Patients With Supratentorial Glioblastoma Multiforme

3. Radiation Therapy and Tamoxifen in Treating Adults With Newly Diagnosed Supratentorial Glioblastoma Multiforme

4. Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma

5. Tipifarnib and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

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