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

Wilex AG0 个研究点目标入组 612 人开始时间: 2004年7月19日最近更新: 2012年12月10日

适应症

试验速览

暂无简介。

•- 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

•- 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.

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