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Surgery and Adjuvant Immunotherapy with BCG and Levamisole for Completely Resected non-Small Cell Cancer of the Lung
Basic Trial Information
Objectives I. Compare potential efficacy of immunotherapy with intrapleural BCG plus levamisole placebo vs. immunotherapy with combined intrapleural BCG and levamisole vs. BCG placebo and levamisole placebo in patients following resection for non-small cell carcinoma of the lung. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients with histologically proven squamous cell carcinoma, adenocarcinoma, or undifferentiated large cell carcinoma of the lung. Patients with undifferentiated small cell (oat cell) carcinoma will not be included. Lung cancer must be completely resected prior to entry. Patients must have no serious concomitant disease; they must have adequate renal, pulmonary, and hepatic function. Expected Enrollment An accrual rate of approximately 70 patients per year in Strata I, II, and III is anticipated. Approximately three years of patient accrual will be required. Protocol closed. Outline Randomized, non-blind study. All patients upon entry will be assigned to one of four strata by clinical TNM classification: Stratum I (T1N0M0); Stratum II (T2N0M0 and T1N1M0); Stratum III (T2N1M0); and Stratum IV (T3N0M0 and T3N1M0). Prior to Surgery, patients will be randomly assigned either Levamisole or Levamisole placebo. Patients in Strata I, II, III, or IV who were assigned Levamisole will receive active BCG (Arm I); patients in Strata I or II who were assigned Levamisole placebo will be randomly assigned active BCG (Arm II) or BCG placebo (Arm III). Arm I: Surgery plus 2-Drug Immunotherapy. BCG, unspecified, no NSC number; Levamisole, LEV, NSC-177023; Isoniazid, INH, NSC-9659. Arm II: Surgery plus Single-agent Immunotherapy. BCG; Levamisole placebo; INH. Arm III: Control. Surgery plus BCG/INH placebo plus LEV placebo. Trial Lead Organizations Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center
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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