Treatment of Patients With Advanced Renal Cancer With a Radio-labeled Antibody, Yttrium-90 Conjugated Chimeric G250
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Cell Carcinoma Kidney Neoplasm Renal Cancer Kidney Cancer |
Drug: Yttrium-90 conjugated chimeric G250 (90Y-cG250) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Cohort Study of Increasing Doses of Yttrium-90 Conjugated to Chimeric Monoclonal Antibody cG250 (90Y-DOTA-cG250) in Patients With Advanced Renal Cancer |
- Toxicity defined by NCI Common Toxicity Criteria
- Assessment of selective uptake of 111In-cG250 in tumor with favorable biodistribution
- Radiation absorbed dose to blood and whole body of 90Y-cG250 as determined by measurement of 111-In in serum and whole body
- HACA - measured by ELISA
| Estimated Enrollment: | 24 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Christina E Hong | 212-639-7246 | hongc@mskcc.org |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Steve Larson, MD 212-693-7373 | |
| Contact: Motzer | |
| Principal Investigator: Steve Larson, MD | |
| Principal Investigator: Joseph O'Donoghue, PhD | |
| Principal Investigator: Neeta Pandit-Taskar, M D | |
| Principal Investigator: Robert Mozter, MD | |
| Principal Investigator: | Robert Motzer, MD | Memorial Sloan-Kettering Cancer Center |
| Principal Investigator: | Neeta Pandit-Taskar, MD | Memorial Sloan-Kettering Cancer Center |
| Principal Investigator: | Joseph O'Donoghue, PhD | Memorial Sloan-Kettering Cancer Center |
| Principal Investigator: | Steve Larson, MD | Memorial Sloan-Kettering Cancer Center |
More Information
No publications provided
| Responsible Party: | Ralph Venhaus, MD, Head of Clinical and Regulatory Affairs, Ludwig Institute for Cancer Research |
| ClinicalTrials.gov Identifier: | NCT00199875 History of Changes |
| Other Study ID Numbers: | LUD2002-022, MSKCC IRB #: 05-031 |
| Study First Received: | September 13, 2005 |
| Last Updated: | May 9, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Ludwig Institute for Cancer Research:
|
antibody renal cell carcinoma advanced renal cancer cG250 90Y |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma Carcinoma, Renal Cell Kidney Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Adenocarcinoma Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Kidney Diseases Urologic Diseases Antibodies Immunoconjugates Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013