Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Active Not specified Other LUD2002-022 MSKCC IRB #: 05-031, NCT00199875

Trial Description

Summary

This is a phase 1 study that will only be carried out at Memorial Sloan-Kettering Cancer Center. Patients will receive a radiolabeled antibody, called Yttrium-90 chimeric G250 (90Y-cG250).The goal of a phase 1 trial is to establish a safe dose range based on side effects;in other studies, these side effects have been reversible and lasted a short time (hours to days). If possible, the trial will also give us an idea of how well the drug might work in treating your disease.

Further Study Information

This is a Phase I dose escalation study using 90Y-DOTA-cG250 for treatment of patients with advanced kidney carcinoma. The initial group of patients will be treated with 0.2 mCi/Kg of yttrium-90. Subsequent treatments will be in 0.1 mCi/Kg increments, with the last cohort increasing by 0.05 mCi/Kg. At least three patients per dose level will be followed for up to 8 weeks (or after recovery from toxicity) with imaging, biochemical, serological, and hematologic tests for toxicity. CT scans will be carried out at baseline and after 6-8 weeks (or after recovery from toxicity).

Patients will initially receive 5 mCi/10 mg 111In-DOTA-cG250 antibody (an imaging dose). Whole body and blood measurements of radioactivity will be obtained on at least three occasions for one week to determine targeting and dosimetry. Therapeutic 90Y-DOTA-cG250 will be administered the following week, if there is evidence of In-111 cG250 targeting to lesions > 2 cm detected on CT. Patients will be treated as outpatients and will receive only one treatment.

Eligibility Criteria

Inclusion Criteria:

• All patients must have histologically proven clear cell renal carcinoma.

• All patients must have a clinical presentation consistent with metastatic renal carcinoma.

• Patients must have bidimensionally measurable disease by conventional imaging methods including radiography, ultrasound, computer tomography, or other anatomic imaging modalities.

• Female patients of childbearing age are required to have a negative pregnancy test carried out the day of and prior to receiving therapy

• All patients must be ambulatory with a Karnofsky Performance Status of at least 70

Exclusion Criteria:

• Significant prior radiotherapy to the entire pelvis and/or lumbosacral spine.

• Clinically significant cardiac disease

• Serious infection or other serious illness.

• Evidence of CNS tumor involvement.

• Patients known to have hepatobiliary disease and/or HIV/AIDS.

• Pregnancy or breastfeeding.

• Refusal or inability to use effective means of contraception in men or women of childbearing potential.

Trial Contact Information

Trial Lead Organizations/Sponsors

Ludwig Institute for Cancer Research

Robert Motzer, MD

Principal Investigator

Neeta Pandit-Taskar, MD

Principal Investigator

Joseph O'Donoghue, PhD

Principal Investigator

Steve Larson, MD

Principal Investigator

Christine E Pierre, BA		Ph: 212-693-7246
		Email: pierrec@mskcc.org

U.S.A.
New York
	New York
	Memorial Sloan-Kettering Cancer Center
		Steve Larson, MD	Ph: 212-693-7373
		Motzer
		Steven M. Larson	Principal Investigator
		Joseph O'Donoghue, PhD	Principal Investigator
		Neeta Pandit-Taskar, M D	Principal Investigator
		Robert Mozter, MD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00199875
Information obtained from ClinicalTrials.gov on July 16, 2008