Expired Study
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Baltimore, Maryland 21231


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00032097


Primary Contact:

Study Chair
James L. Pearlman, MD
H. Lee Moffitt Cancer Center and Research Institute


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21231
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 13, 2017

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