PHASE II STUDY OF LUTETIUM-177 LABELED CHIMERIC MONOCLONAL ANTIBODY cG250 (177Lu-DOTA-cG250) IN PATIENTS WITH ADVANCED RENAL CANCER - Phase II Lutetium

• Conditions: Patients with metastatic clear cell renal cell carcinoma; MedDRA version: 9.1Level: PTClassification code 10050513Term: Metastatic renal cell carcinoma

• Registration Number: EUCTR2008-004548-35-NL
• Lead Sponsor: Radboud university nijmegen medical centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with proven advanced and progressive renal cell carcinoma of the clear cell type
At least one evaluable lesion less than 5 cm
Performance status: Karnofsky > 70 %
Laboratory values obtained less than 14 days prior to registration:
White blood cells (WBC) > 3.5 x 109/l
Platelet count > 100 x 109/l
Hemoglobin > 6 mmol/l
Total bilirubin < 2 x upper limit of normal (ULN)
ASAT, ALAT < 3 x ULN (< 5 x ULN if liver metastases present)
Serum creatinine < 2 x ULN
Negative pregnancy test for women of child¬bearing potential (urine or serum)
Age over 18 years
Ability to provide written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Known metastases to the brain
Untreated hypercalcemia
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. Limited field external beam radiotherapy to prevent pathological fractures is allowed, when unirradiated, evaluable lesions elsewhere are present.
Cardiac disease with New York Heart Association classification of III or IV
Patients who are pregnant, nursing or of reproductive potential and are not practicing an effective method of contraception
Any unrelated illness, e.g. active infection, inflammation, medical condition or laboratory abnormalities, which in the judgment of the investigator will significantly affect patients’ clinical status
Life expectancy shorter than 6 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified