Overview

Vaccine Therapy Plus QS21 in Treating Patients With Small Cell Lung Cancer That Has Responded to Initial Therapy

Status:
Completed
Trial end date:
2001-11-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Biological therapies, such as QS21, use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy plus QS21 in treating patients who have small cell lung cancer that has responded to initial therapy.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Keyhole-limpet hemocyanin
QS 21
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed small cell lung cancer Must have
completed initial therapy with or without radiotherapy and have achieved a complete
response or partial response to therapy without subsequent evidence of disease progression
Must have completed any radiotherapy including prophylactic cranial radiotherapy as part of
the planned primary therapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Lymphocyte count at least
500/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 1.5 times upper
limit of normal (ULN) Alkaline phosphatase no greater than 1.5 times ULN Renal: Not
specified Cardiovascular: No New York Heart Association class III or IV heart disease
Other: No known immunodeficiency or autoimmune disease No other active malignancies within
the past 5 years except nonmelanoma skin cancer No clinically significant peripheral
neuropathy Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 4 weeks
but no more than 12 weeks since prior initial therapy and recovered Chemotherapy: See
Disease Characteristics At least 4 weeks but no more than 12 weeks since prior initial
therapy and recovered Endocrine therapy: See Disease Characteristics At least 4 weeks but
no more than 12 weeks since prior initial therapy and recovered No concurrent
corticosteroids Radiotherapy: See Disease Characteristics At least 4 weeks but no more than
12 weeks since prior initial therapy and recovered No prior radiotherapy to the spleen
Surgery: No prior splenectomy