Monoclonal Antibody Therapy in Treating Patients With Advanced Kidney Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003102
First received: November 1, 1999
Last updated: December 2, 2009
Last verified: December 2009
  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.


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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 48
Study Start Date: July 1997
Primary Completion Date: August 2000 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003102

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Chaitanya R. Divgi, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003102     History of Changes
Other Study ID Numbers: CDR0000065834, MSKCC-97049, NCI-H97-0004
Study First Received: November 1, 1999
Last Updated: December 2, 2009
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on September 30, 2014