Expired Study
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New York, New York 10021


Purpose:

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy in treating patients with advanced kidney cancer.


Study summary:

OBJECTIVES: I. Define the safety of iodine I 131 chimeric monoclonal antibody G250 (131I MOAB cG250) in patients with advanced renal cell carcinoma. II. Determine the maximum tolerated dose (MTD) of 131I MOAB cG250. III. Describe the pharmacokinetics and biodistribution of 131I MOAB cG250. IV. Determine the response rate of 131I MOAB cG250 at the MTD. OUTLINE: This is a dose escalation study. Initially patients receive a scout dose of IV iodine I 131 chimeric monoclonal antibody G250 (131I MOAB cG250) over 10 minutes to determine whole body clearance. One week later, patients receive incremental doses of IV 131I MOAB cG250 over 10 minutes at 2-3 day intervals for 2-6 weeks. Dose escalation begins at least 8 weeks after the last infusion of 131I MOAB cG250. In the absence of dose limiting toxicity in the first 3 patients treated, subsequent cohorts of 3 patients each receive escalating doses of 131I MOAB cG250 on the same schedule. If dose limiting toxicity occurs in 4 of 6 patients treated at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose (MTD). Treatment continues once recovery from all toxic effects occurs, beginning 8 to 12 weeks following the last course of 131I MOAB cG250. Patients achieving complete remission, partial remission, or stable disease receive up to 3 courses of treatment. Treatment ceases once disease progression is reached following 8 weeks of 131I MOAB cG250. PROJECTED ACCRUAL: This study will accrue a maximum of 48 patients, with 24 patients per Phase, at an anticipated enrollment of 2 patients per month over 24 months.


Criteria:

DISEASE CHARACTERISTICS: Histologically proven renal cell carcinoma Clinical presentation consistent with metastatic renal cell carcinoma Bidimensionally measurable disease No CNS tumor involvement PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 70-100% Life expectancy: At least 6 weeks Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Prothrombin time less than 1.3 times control Hepatic: Serum bilirubin no greater than 1 mg/dL Renal: Serum creatinine no greater than 2 mg/dL Cardiovascular: No New York Heart Association Class III/IV Other: No serious infection or illness Not pregnant or lactating Effective contraception required of fertile patients No hypercalcemia greater than 12.5 mg/dL or symptomatic PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior immunotherapy Chemotherapy: At least 6 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No significant prior radiation therapy to the entire pelvis and/or lumbosacral spine Surgery: Not specified Other: No concurrent antibiotics


NCT ID:

NCT00003102


Primary Contact:

Study Chair
Chaitanya R. Divgi, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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