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

Active, not recruiting

Conditions: Clear cell renal cell carcinoma after surgery with no evidence of residual disease and with high risk of recurrence
MedDRA version: 4.0Level: LLTClassification code 10038416

Registration Number: EUCTR2004-000353-38-FI

Lead Sponsor: Wilex AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 612

Inclusion Criteria

- Prior nephrectomy of primary renal cell carcinoma with documented clear cell histology
- Adenectomy of regional lymph nodes and staging is required
- No evidence of macroscopic and microscopic residual disease
- Patients diagnosed of having one of the following (referring to TNM classification, 6th edition UICC, 2002):
* histologically proven stage T3bN0M0 or T3cN0M0 or T4N0M0
* any histologically proven T stage and N+ disease
* primary tumor T1bN0M0 or T2N0M0 or T3aN0M0, each with microscopic vascular invasion and grade >/= III (grading system with at least 3 grades)
- ECOG of 0
- Not more than 6 weeks after nephrectomy
- Negative HIV- and hepatitis test
- Negative pregnancy test for women of child-bearing potential
- Women of child-bearing potential must be taking adequate contraceptive precautions
- Willingness to return to the study site for long term control visits until recurrence
- Age >/= 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

- Pre-exposure to murine/chimeric antibody therapy
- Patients who require or are likely to require corticosteroids for another disease (patients on physiologic corticosteroid replacement therapy may be included in the study at the discretion of the investigator)
- Prior organ transplantation
- Laboratory values obtained * White blood cells (WBC) * Platelet count * Hemoglobin * Total bilirubin >/= 1.5 ULN
* ASAT, ALAT >/= 3 x ULN
* Serum creatinine >/= 2x ULN
- History of prior malignancies within the last 5 years, except for surgically-cured non-melanoma skin cancer, or cervical carcinoma in situ.
- Prior radiation or chemotherapy within the last 5 years.
- Patients who are pregnant, nursing or of reproductive potential and are not practising an effective method of contraception.
- Any unrelated illness, e.g. active infection, inflammation, medical condition or laboratory abnormalities, which in the judgement of the investigator will significantly jeopardize patients' clinical status.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of treatment by assessing the disease-free survival and overall survival in the treatment arm compared to the placebo arm.<br>;Secondary Objective: To evaluate the safety of the antibody therapy and the impact on the quality of life.;Primary end point(s): Primary study endpoints are disease-free survival and overall survival.

Secondary Outcome Measures

Name	Time	Method

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