EUCTR2004-000353-38-CZActive, not recruitingPhase 1
A randomized double blind phase III study to evaluate adjuvant cG250 treatment versus placebo in patients with clear cell RCC and high risk of recurrence - ARISER
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Wilex AG
- Enrollment
- 856
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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