Monoclonal Antibody Therapy in Treating Patients With Advanced Kidney Cancer

NCT00003102 | Completed Phase 1 Results FDA Drug

• 4 other identifiers: CDR0000065834MSKCC-97049NCI-H97-0004LUD 96-006
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancer; recurrent renal cell cancer

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Adverse Events (AEs)

  All adverse events occurring during the study were to be recorded on the patient's case report form, and include the following information: a description; date of onset and resolution; severity; relationship to an investigational agent; action taken and outcome. Toxicity was graded in accordance with the NCI CTCAE version 3.0.

  Up to 12 months

• Number of Patients With Dose-Limiting Toxicities (DLTs)

  Subjects were monitored for Adverse Events (AEs) for at least 8 weeks after the last infusion of 131I-cG250, or until recovery from all toxicity, and prior to dose escalation. Toxicity was graded in accordance with the Common Toxicity Criteria (CTC) of the National Cancer Institute (NCI) Version 3.0. Dose-Limiting Toxicity (DLT) was defined as grade 3 or greater toxicity related to study therapy. The maximum tolerated dose was defined as the highest safely tolerated dose where at most one of six patients experiences a DLT with the next higher dose having at least two patients who experience a DLT.

  up to 12 months

Secondary Outcomes (2)

• Number of Patients With Best Overall Tumor Response

  Up to 12 weeks

• Number of Patients With Human Anti-chimeric Antibodies (HACA)

  Up to 6 months

Study Arms (3)

Cohort 1 50cGy radiation

EXPERIMENTAL

On day 1, patients received a single dose of 131I-cG250 (5 mCi/5 mg) administered as an intravenous infusion over 10 minutes. Therapeutic doses of 131I-cG250 were administered the following week as fractionated outpatient doses, starting with 30 millicurie (mCi)/5 mg 131I-cG250. Subsequent doses of 131I-cG250 were administered at 2-3 day intervals with the total amount of 131I-cG250 administered based on the calculated clearance of the initial dose administered on day 1. Whole body activity was maintained at no more than 30 mCi iodine-131. In the absence of disease progression and after recovery from toxicity, patients could be re-treated beginning 8 weeks after the last treatment of the initial series, for a total of not more than 3 treatments.

Biological: Iodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250)

Cohort 2 75cGy radiation

EXPERIMENTAL

On day 1, patients received a single dose of 131I-cG250 (5 mCi/5 mg) administered as an intravenous infusion over 10 minutes. Therapeutic doses of 131I-cG250 were administered the following week as fractionated outpatient doses, starting with 30 millicurie (mCi)/5 mg 131I-cG250. Subsequent doses of 131I-cG250 were administered at 2-3 day intervals with the total amount of 131I-cG250 administered based on the calculated clearance of the initial dose administered on day 1. Whole body activity was maintained at no more than 30 mCi iodine-131. In the absence of disease progression and after recovery from toxicity, patients could be re-treated beginning 8 weeks after the last treatment of the initial series, for a total of not more than 3 treatments.

Biological: Iodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250)

Cohort 3 100cGy radiation

EXPERIMENTAL

On day 1, patients received a single dose of 131I-cG250 (5 mCi/5 mg) administered as an intravenous infusion over 10 minutes. Therapeutic doses of 131I-cG250 were administered the following week as fractionated outpatient doses, starting with 30 millicurie (mCi)/5 mg 131I-cG250. Subsequent doses of 131I-cG250 were administered at 2-3 day intervals with the total amount of 131I-cG250 administered based on the calculated clearance of the initial dose administered on day 1. Whole body activity was maintained at no more than 30 mCi iodine-131. In the absence of disease progression and after recovery from toxicity, patients could be re-treated beginning 8 weeks after the last treatment of the initial series, for a total of not more than 3 treatments.

Biological: Iodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250)

Interventions

Iodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250) BIOLOGICAL

cG250 is an IgG1 chimeric monoclonal antibody. It was supplied as a sterile solution at a concentration of 1.0 mg/mL in either a 2 mL or a 5 mL vial. cG250 was radiolabeled with Iodine-131 prior to use.

Cohort 1 50cGy radiation; Cohort 2 75cGy radiation; Cohort 3 100cGy radiation

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven renal cell carcinoma. Clinical presentation consistent with metastatic renal cell carcinoma. Bidimensionally measurable disease by conventional imaging. Patients must have been off chemotherapy or immunotherapy for at least 6 weeks prior to study entry.
• Women of child-bearing age must have had a negative pregnancy test carried out the day of and prior to receiving therapy, and were asked to use effective contraception during the study.
• Patients were required to be ambulatory with a Karnofsky Performance Status at least 70, Serum creatinine ≤ 2mg/dl, Serum bilirubin ≤ 1mg/d, White Blood Cells (WBC) ≥ 3,500/mm\^3, Platelet count ≥ 100,000/mm\^3, Prothrombin time \< 1.3 x control.

You may not qualify if:

• Significant prior radiation therapy to the entire pelvis and/or lumbosacral spine.
• Clinically significant cardiac disease. Serious infection requiring treatment with antibiotics, or other serious illness.
• Women who are pregnant or lactating. Central Nervous System (CNS) tumor involvement. Life expectancy less than 6 weeks. Hypercalcemia greater than 12.5 mg/dL or symptomatic.

Sponsors & Collaborators

• Ludwig Institute for Cancer Research: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Jonathan Skipper PhD
• Organization: Ludwig Institute for Cancer Research

jskipper@lcr.org

12124501539

Study Officials

• Chaitanya R. Divgi, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 12, 2004
• Study Start: November 17, 1998
• Primary Completion: April 19, 2000
• Study Completion: May 27, 2003
• Last Updated: October 4, 2023
• Results First Posted: January 5, 2022

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)