PHASE II STUDY OF LUTETIUM-177 LABELED CHIMERIC MONOCLONAL ANTIBODY cG250 (177Lu-DOTA-cG250) IN PATIENTS WITH ADVANCED RENAL CANCER
Phase 2
Completed
- Conditions
- kidney cancerradioimmunotherapy1003836410038430
- Registration Number
- NL-OMON33866
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 9
Inclusion Criteria
Patients with proven advanced and progressive renal cell carcinoma of the clear cell type
Performance status: Karnofsky > 70 %
Adequate bone marrow function
Age over 18 years
Exclusion Criteria
Known metastases to the brain
Metastatic disease limited to the bone
Pre-exposure to murine/chimeric antibody
Chemotherapy, external beam radiation, immunotherapy or angiogenesis inhibitors within 4 weeks prior to study.
Life expectancy shorter than 6 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Determine the clinical efficacy of multiple doses of 177Lu-DOTA-cG250 at MTD in<br /><br>patients with advanced renal cancer using RECIST criteria</p><br>
- Secondary Outcome Measures
Name Time Method <p>Determine the toxicity of the treatment as defined by NCI Common Terminology<br /><br>Criteria for Adverse Events (CTCAE v3.0)<br /><br><br /><br>Determine the targeting and dosimetry of 111In-DOTA-cG250 in patients with<br /><br>advanced renal cancer, as a surrogate for 177Lu-DOTA-cG250 </p><br>