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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Lee M. Krug, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

98-065

NCT ID:

NCT00004249

Start Date:

August 1998

Completion Date:

November 2001

Related Keywords:

  • Lung Cancer
  • limited stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021