Treatment of Patients With Advanced Renal Cancer With a Radio-labeled Antibody, Yttrium-90 Conjugated Chimeric G250
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
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
Name: Yttrium-90 conjugated chimeric G250 (90Y-cG250)
Type: Drug
Overall Status
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.
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
Ludwig Institute for Cancer Research
Ludwig Institute for Cancer Research
Record processing date processed this data on July 28, 2015 page