SWOG clinical trial number
S0122

Phase II Trial of Patients with Limited Stage Small Cell Lung Cancer Treated with Thoracic Radiation Therapy and Chemotherapy with Cisplatin/Etoposide Followed by Cisplatin/Etoposide and Anti-Idiotype Monoclonal Antibody Vaccines

Closed
Phase
Accrual
10%
Abbreviated Title
Cisplat/Etopo/RT followed by Cisplat/Etopo/TriAb & TriGem Vaccines in Limited SCLC
Activated
12/15/2002
Closed
05/15/2003
Participants
NCORP, Members, Medical Oncologists, Radiation Oncologists

Research committees

Lung Cancer

Treatment

Cisplatin Etoposide TriAb TriGem RT

Eligibility Criteria Expand/Collapse

Pts must have histologically/cytologically-confirmed limited SCLC (diagnosis based on sputum is acceptable); evidence of dz by Chest CT; >/= 2 weeks from surgery and recovered (dz must be present outside the area of surgical resection); pts must be willing to participate in immune studies; FEV1 and DLCO obtained; ANC >/= 1,500; PLTS >/= 100,000; PS 0-1; serum creatinine </= IULN or CrCl >/= 60 cc/min (meas. or calc.); 18 yrs or older; no other prior malignancy except: treated basal cell or squamous cell skin ca, in situ cervical ca, Stage I or II ca in complete remission (disease-free from any ca for 5 yrs.); pts with malignant pericardial or pleural effusions are not eligible; pts must not have had prior chemo, thoracic RT or biologic tx for SCLC; pts must not have received prior TriAb/TriGem or have a hx of sensitivity; pts must not have known exposure to murine antibodies or known sensitivity to rodent proteins; pts must not have CNS dz by CT or MRI of brain; pts must not have received investigational device/agent, immunotherapy, immunization or systemic corticosteroids (except as part of anti-emetic regimen) w/in 30 days or must not be planning to receive systemic corticosteroids or other immunosuppressants, etc.; pts must not have >/= Grade 1 symptomatic neuropathy-sensory; pts must not be hearing impaired and unwilling to accept further worsening; pts must not be pregnant or nursing or of reproductive potential and not agreed to use of effective contraceptive method.