S0122: Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Limited-Stage Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 2003-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. Vaccines may make the body build an immune response to kill tumor cells. Combining chemotherapy and radiation therapy with vaccine therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy with vaccine therapy in treating patients who have limited-stage small cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antibodies; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Cisplatin; Etoposide; Etoposide phosphate; Immunoglobulin Idiotypes; Immunoglobulins; Vaccines

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed limited stage small cell lung cancer (SCLC)

• Evidence of disease by CT scan of the chest

• Measurable or evaluable disease outside of area of prior surgical resection

• No malignant pericardial or pleural effusions (cytologically positive effusions or exudative effusions not attributable to other etiologies)

• No CNS disease by chest CT scan or MRI

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic

• Not specified

Renal

• Creatinine no greater than upper limit of normal OR

• Creatinine clearance at least 60 mL/min

Other

• No prior hypersensitivity or contraindication to monoclonal antibody 11D10 anti-idiotype vaccine (TriAb), monoclonal antibody GD2 anti-idiotype vaccine (TriGem), or aluminum hydroxide

• No known sensitivity to rodent proteins (i.e., anti-OKT-3, ONCOSCINT scan)

• No grade 1 or greater symptomatic sensory neuropathy

• No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer in complete remission, or any other cancer for which patient has been disease free for 5 years

• If significant clinical hearing loss already present, must accept risk of further hearing loss

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior biologic therapy for SCLC

• No prior TriAb or TriGem

• No prior murine antibodies

• No prior mouse proteins

• At least 30 days since prior immunotherapy

• At least 30 days since any prior immunization

Chemotherapy

• No prior systemic chemotherapy for SCLC

• No concurrent cyclophosphamide or methotrexate

Endocrine therapy

• At least 30 days since prior systemic corticosteroids

• No concurrent systemic corticosteroids (except as an antiemetic)

Radiotherapy

• No prior radiotherapy to the thorax or neck region

• No concurrent intensity modulated radiotherapy

Surgery

• See Disease Characteristics

• At least 2 weeks since prior thoracic or other major surgery and recovered

Other

• At least 30 days since prior investigational agents or devices

• No other concurrent investigational agents

• No other concurrent immunosuppressants (e.g., cyclosporine)

• No concurrent chronic systemic antihistamines

• No concurrent amifostine