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

NCT00004249 | Completed Phase 2

• 3 other identifiers: 98-065CDR0000067495NCI-H99-0047
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Keywords

limited stage small cell lung cancer

Interventions

QS21 BIOLOGICAL

keyhole limpet hemocyanin BIOLOGICAL

polysialic acid DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

saponin QA-21V1; keyhole-limpet hemocyanin; polysialic acid

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lee M. Krug, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 28, 2000
• First Posted: April 28, 2004
• Study Start: August 1, 1998
• Primary Completion: November 1, 2001
• Study Completion: November 1, 2001
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

US (1)