A clinical study to evaluate treatment of the study drug cG250 in patients with kidney cancer after complete removal of kidney cancer and high risk of recurrence of the cancer. A comparator arm is included in which the patients receive placebo (inactive substance without medication). The assignment of the study medication is determined by chance. Neither the patient nor the study doctor will know whether the patient is receiving active drug or placebo.
- Conditions
- Renal cell carcinoma of the clear cell type after nephrectomy and no evidence of residual diseaseMedDRA version: 14.1Level: LLTClassification code 10038415Term: Renal cell carcinoma stage unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2004-000353-38-GB
- Lead Sponsor
- Wilex AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 856
1. Prior (partial or total) nephrectomy of primary renal cell carcinoma with documented clear cell histology
2. No evidence of macroscopic and microscopic residual disease (enlarged lymph nodes schould be removed)
3. Patients diagnosed of having one of the following (referring to TNM classification, 6th edition UICC, 2002):
- Risk group I: T3aN0/XM0 or T3bN0/XM0 or T3cN0/XM0 or T4N0/XM0
- Risk group II: any T stage and N+ disease and M0
- Risk group III: T1bN0/XM0 or T2N0/XM0, each with grading >=3 (Fuhrman or any other nuclear grading system with at least 3 grades)
4. ECOG of 0-1 (see Appendix II)
5. Not more than 12 weeks between date of nephrectomy and randomization
6. Negative HIV I and II test
7. Negative Hepatitis B surface antigen (HbsAg) or Hepatitis C antibody result
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 631
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 233
1. Pre-exposure to murine/chimeric antibody therapy
2. Patients who require or are likely to require systemic corticosteroids above Cushing doses for another disease (patients on physiologic corticosteroid replacement therapy may be included in the study at the discretion of the investigator)
3. Prior organ transplantation
4. Laboratory values obtained <= 3 weeks before randomization:
- White blood cells (WBC) <= 3.0 x 108/dl
- Platelet count <= 100 x 108/dl
- Hemoglobin <= 6.2 mmol/l (equals 10 g/dl)
- Total bilirubin >= 1.5 x upper limit of normal (ULN)
- ASAT, ALAT >= 3 x ULN
- Serum creatinine >= 2 x ULN
5. History of prior malignancies within the last 5 years, except for surgically-cured non-melanoma skin cancer, or cervical carcinoma in situ
6. Prior radiation or immunotherapy or chemotherapy within the last 5 years
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method