Monoclonal Antibody Therapy in Treating Patients With Advanced Kidney Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003102
Recruitment Status : Completed
First Posted : August 12, 2004
Last Update Posted : December 3, 2009
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Kidney Cancer Radiation: iodine I 131 chimeric monoclonal antibody G-250 Phase 1 Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Primary Purpose: Treatment
Official Title: Phase I/II Study of 131-I-Labeled Chimeric Antibody G250 (131-I-cG250) in Patients With Advanced Renal Carcinoma
Study Start Date : July 1997
Actual Primary Completion Date : August 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003102

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Chaitanya R. Divgi, MD Memorial Sloan Kettering Cancer Center Identifier: NCT00003102     History of Changes
Other Study ID Numbers: CDR0000065834
First Posted: August 12, 2004    Key Record Dates
Last Update Posted: December 3, 2009
Last Verified: December 2009

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs