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Vaccine Therapy Plus QS21 in Treating Patients With Prostate Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center Identifier:
First received: May 2, 2000
Last updated: January 30, 2013
Last verified: January 2013

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Combining a vaccine with QS21 may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus immune adjuvant QS21 in treating patients who have prostate cancer.

Condition Intervention Phase
Prostate Cancer Biological: MUC1-KLH vaccine/QS21 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vaccination of Prostate Cancer Patients With MUC-1-KLH Conjugate Plus the Immunological Adjuvant QS21: A Trial Examining the Immunogenicity of MUC-1 Glycopeptide Conjugate

Resource links provided by NLM:

Further study details as provided by Memorial Sloan Kettering Cancer Center:

Enrollment: 27
Study Start Date: June 1999
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine
Patients sequentially will receive glycosylated MUC-1-KLH vaccines at 3ug per vaccination.
Biological: MUC1-KLH vaccine/QS21

Detailed Description:

OBJECTIVES: I. Determine if immunization with glycosylated MUC-1 antigen containing MUC-1 (106) with keyhole limpet hemocyanin conjugate plus immunological adjuvant QS21 induces an antibody, helper T cell and/or cytotoxic T cell response against MUC-1 in patients with prostate cancer expressing MUC-1. II. Determine post-immunization changes in PSA levels and other objective parameters or disease (radionuclide bone scan and/or measurable disease if present) in these patients after receiving this therapy.

OUTLINE: Patients receive glycosylated MUC-1 antigen containing MUC-1 (106) with keyhole limpet hemocyanin conjugate subcutaneously (SQ) plus immunological adjuvant QS21 SQ on weeks 1-3, 7, 15, and 27 for a total of 6 vaccinations. Patients are followed every 3 months for 1 year or until documented disease progression.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer No radiographic evidence of metastatic disease Must show signs of disease progression 3 or more rising PSA values documented, taken at no less than weekly intervals, to greater than 50% above baseline PSA PSA at least 1.0 ng/mL (post prostatectomy) OR 2.0 ng/mL (post radiation) Evaluable disease by serial changes in PSA Progression after primary therapy to include surgery or radiotherapy (with or without neoadjuvant androgen ablation), or intermittent hormonal therapy with noncastrate levels of testosterone (greater than 50 ng/mL) allowed No soft tissue and/or bone disease or androgen independent disease with no evidence of radiographic disease No symptomatic disease or anticipated to be symptomatic within 6 months No active CNS or epidural tumor

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 6 months Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL OR SGOT less than 3 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 40 mL/min Cardiovascular: No New York Heart Association class III-IV heart disease Pulmonary: No severe debilitating pulmonary disease Other: No other malignancy within past 5 years except nonmelanoma skin cancer No concurrent infection requiring antibiotics No narcotic dependent pain No positive stool guaiac excluding hemorrhoids No history of documented radiation induced proctitis No allergy to seafood

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibody therapy No other concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No concurrent chemotherapy Endocrine therapy: See Disease Characteristics At least 2 weeks since prior changes in hormonal therapy including prednisone or dexamethasone At least 8 weeks since prior suramin OR documented plasma concentration less than 50 mg/mL (replacement doses of hydrocortisone allowed) Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy to only measurable lesion Surgery: See Disease Characteristics No concurrent surgery Other: No other concurrent anticancer agents

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Please refer to this study by its identifier: NCT00005632

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Susan Slovin, MD, PhD Memorial Sloan Kettering Cancer Center
  More Information

Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00005632     History of Changes
Other Study ID Numbers: 99-040
Study First Received: May 2, 2000
Last Updated: January 30, 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
QS 21
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic processed this record on June 23, 2017