Treatment of Patients With Advanced Renal Cancer With a Radio-labeled Antibody, Yttrium-90 Conjugated Chimeric G250
Conditions
Renal Cell Carcinoma - Kidney Neoplasm - Renal Cancer - Kidney Cancer
Conditions: official terms
Carcinoma, Renal Cell - Kidney Neoplasms
Conditions: Keywords
antibody, renal cell carcinoma, advanced renal cancer, cG250, 90Y
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Yttrium-90 conjugated chimeric G250 (90Y-cG250)
Type: Drug
Overall Status
Recruiting
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.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
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.
Location
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Steve Larson, MD - 212-693-7373
Start Date
July 2005
Completion Date
September 2012
Sponsors
Ludwig Institute for Cancer Research
Source
Ludwig Institute for Cancer Research
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page