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Phase II/III Randomized Study of Adjuvant Active Specific Immunotherapy with Autologous Tumor Cells and BCG plus CTX and Low-Dose IL-2 for Stage II/III Renal Cell Adenocarcinoma (Summary Last Modified 09/97)
Basic Trial Information
Objectives I. Determine the degree and duration of immune response following active specific immunotherapy with autologous tumor cells and BCG plus cyclophosphamide and low-dose interleukin-2 in patients with previously resected stage II/III renal cell adenocarcinoma. II. Assess the recurrence and survival rates following this treatment. Entry Criteria Disease Characteristics: Histologically diagnosed renal cell adenocarcinoma No contralateral synchronous or metachronous disease Pathologic stage II (pT2 N0 M0) or stage III (pT3a-b N0 M0 or pT1-3 N1 M0) disease Prior radical nephrectomy with no evidence of residual tumor required Prior/Concurrent Therapy: Biological therapy: No prior biological response modifier therapy Chemotherapy: No prior chemotherapy Endocrine therapy: No prior hormonal therapy Radiotherapy: No prior radiotherapy to the primary tumor Surgery: See Disease Characteristics At least 28 days since surgery and recovered Patient Characteristics: Age: Under 75 Performance status: Karnofsky 50%-100% Other: No major organ dysfunction that precludes protocol treatment No prior or concurrent malignancy Expected Enrollment A total of 100 patients will be accrued over 3 years. Outline Randomized study. The following acronyms are used: ATC Autologous Tumor Cells BCG Bacillus Calmette-Guerin (strain unspecified) CTX Cyclophosphamide, NSC-26271 IL-2 Interleukin-2 (Chiron), NSC-373364 Arm I: Adoptive Immunotherapy with Immunostimulation. Irradiated ATC/BCG vaccine; with CTX; IL-2. Arm II: Control. Observation only. Trial Lead Organizations European Institute of Oncology
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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