Completed

Phase I/II Study of 131I-Labeled Chimeric Antibody G250 (131I-cG250) in Patients With Advanced Renal Carcinoma

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What is being tested

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

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

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

Biological
Who is being recruted

Urogenital Diseases+13

+ Adenocarcinoma

+ Carcinoma

Over 16 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: November 1998
See protocol details

Summary

Principal SponsorLudwig Institute for Cancer Research
Last updated: October 4, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: November 17, 1998

Actual date on which the first participant was enrolled.

This is a dose-escalation study. Initially patients receive a scout dose of iodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250) administered intravenously (IV) over 10 minutes to determine whole body clearance. One week later, patients receive incremental doses of 131I-cG250 IV 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-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-cG250 on the same schedule. If dose-limiting toxicity occurs in 2 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 dose of 131I-cG250. Patients achieving complete remission, partial remission, or stable disease were eligible to receive up to 3 courses of treatment.

NCT00003102
Principal SponsorLudwig Institute for Cancer Research
Last updated: October 4, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 16 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAdenocarcinomaCarcinomaFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsFemale Urogenital DiseasesMale Urogenital DiseasesCarcinoma, Renal CellKidney Neoplasms

Criteria

Inclusion Criteria 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. Exclusion Criteria 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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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.

Group III

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Memorial Sloan-Kettering Cancer Center

New York, United StatesOpen Memorial Sloan-Kettering Cancer Center in Google Maps
CompletedOne Study Center