Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Treatment Closed no age specified NCI-D78-006-225 YALE-1683

Objectives

I.  Compare two therapeutic programs (levamisole plus radiation, and 
levamisole/BCG plus radiation) against radiotherapy alone for advanced lung 
cancer.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with advanced, unresectable, 
previously untreated non-oat cell carcinoma of the lung (Stage III, Mountain 
classification), with disease limited to the hemithorax, with or without 
involvement of the ipsilateral scalene lymph nodes.  Also eligible will be 
patients with Stage I or II disease who are considered inoperable for medical 
reasons or who refuse surgery; results in these patients will be analyzed 
separately.  Patients with disease metastasis to distant sites outside the 
thorax (other than scalene lymph nodes), rheumatoid arthritis, active liver 
disease, or active, culture-positive tuberculosis will be excluded.  Prior 
corticosteroid or immunosuppressive therapy is not permitted.

Expected Enrollment

Approximately 150 patients will be entered.  Protocol closed.

Outline

Randomized, prospective study.
Arm I:  Single-agent Immunotherapy plus Radiotherapy.  Levamisole, LEV, 
NSC-177023, plus irradiation of the tumor bed and regional, mediastinal, and 
appropriate supraclavicular nodes.
Arm II:  Double-agent Immunotherapy plus Radiotherapy.  LEV; BCG-Tice, BCG, 
NSC-B116327; plus irradiation as in Arm I.
Arm III:  Radiotherapy, as in Arm I.
All patients receive antibacterial support:  Isoniazid, INH, NSC-9659.

Trial Contact Information

Trial Lead Organizations

Yale Cancer Center

Henry J. Durivage, PharmD, Protocol chair		Ph: 203-785-4110; 866-925-3226