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Vaccine Therapy Plus QS21 in Treating Patients With Small Cell Lung Cancer That Has Responded to Initial Therapy
This study is ongoing, but not recruiting participants.
First Received: January 28, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004249
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Biological: QS21
Biological: keyhole limpet hemocyanin
Drug: polysialic acid
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: QS 21
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Immunization Using Polysialic Acid-KLH or N-Propionylated Polysialic Acid-KLH Conjugate Plus the Immunological Adjuvant QS-21 in Patients With Small Cell Lung Cancer Who Have Achieved a Major Response to Initial Therapy

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 1998
Detailed Description:

OBJECTIVES: I. Compare the antibody response after immunization with polysialic acid keyhole limpet hemocyanin (PSA-KLH) conjugate or N-propionylated PSA-KLH conjugate plus immunological adjuvant QS21 in patients with small cell lung cancer. II. Assess the clinical toxicities resulting from these regimens and from the immune response in this patient population.

OUTLINE: Patients receive polysialic acid keyhole limpet hemocyanin (PSA-KLH) conjugate or N-propionylated PSA-KLH conjugate plus immunological adjuvant QS21 subcutaneously weekly on weeks 1-4 and on weeks 8 and 16 for a total of 6 vaccinations. Patients are followed at 2 weeks, and then every 3 months for up to 1 year.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004249

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Lee M. Krug, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067495, MSKCC-98065, NCI-H99-0047
Study First Received: January 28, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004249     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
limited stage small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Immunologic Factors
Carcinoma, Neuroendocrine
Adjuvants, Immunologic
Keyhole-limpet hemocyanin
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
QS 21
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Carcinoma, Neuroendocrine
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Adjuvants, Immunologic
Keyhole-limpet hemocyanin
Pharmacologic Actions
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
QS 21
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009