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Vaccine Therapy Plus QS21 in Treating Patients With Progressive Prostate Cancer
This study has been completed.
First Received: November 1, 1999   Last Updated: April 3, 2009   History of Changes
Sponsor: Memorial Sloan-Kettering Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003819
  Purpose

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy given with QS21 in treating patients who have progressive prostate cancer.


Condition Intervention Phase
Prostate Cancer
Biological: QS21
Biological: TF(c)-KLH conjugate vaccine
Biological: Thomsen-Friedenreich antigen
Biological: keyhole limpet hemocyanin
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: Vaccination of Prostate Cancer Patients With Thompson-Friedenreich [TF(c)]-KLH Conjugate Plus the Immunological Adjuvant QS21: A Trial Comparing TF(c)-KLH Doses

Resource links provided by NLM:


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

Estimated Enrollment: 20
Study Start Date: June 1998
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the optimal dose of Thompson-Friedenreich [TF(c)]-keyhole limpet hemocyanin (KLH) conjugate plus adjuvant QS21 that induces an antibody response in patients with prostate cancer. II. Determine the safety of the TF(c)-KLH conjugate prepared using an MBS heterobifunctional linker plus QS21. III. Assess postimmunization changes in prostate specific antigen levels and other objective parameters of disease in these patients.

OUTLINE: This is a dose escalation study. Patients receive TF(c)-KLH conjugate with adjuvant QS21 subcutaneously weekly for 3 weeks, then once during weeks 7 and 19. Cohorts of 5 patients each receive escalating doses of TF(c)-KLH vaccine until the optimal dose, based on antibody response, is reached. Patients are followed monthly for 6 months, then every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 6 months.

  Eligibility

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

DISEASE CHARACTERISTICS: Histologically proven progressive prostate cancer after primary therapy Radiographic changes OR PSA at least 1.0 ng/mL and rising after prostatectomy OR PSA at least 2.0 ng/mL and rising after radiotherapy OR PSA rising 50% during intermittent hormonal therapy No metastatic disease by radiography No active CNS or epidural tumor Registered on MSKCC-9040

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 6 months Hematopoietic: WBC at least 3500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL OR SGOT less than 3.0 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 cardiac disease Pulmonary: No severe debilitating pulmonary disease Other: No other active malignancy within 5 years except nonmelanomatous skin cancer No infection requiring antibiotics No narcotic dependent pain No positive stool guaiac excluding hemorrhoids No radiation induced proctitis No allergy to seafood

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No concurrent chemotherapy Endocrine therapy: See Disease Characteristics At least 2 weeks since change in hormonal therapy (except to maintain castrate levels of testosterone), including prednisone or dexamethasone At least 8 weeks since prior suramin and/or serum concentration of suramin must be less than 50 micrograms/mL (replacement hydrocortisone allowed) Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No concurrent therapy to only measurable lesion Surgery: See Disease Characteristics No concurrent surgery

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003819

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: Susan Slovin, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000066971, MSKCC-98048, NCI-G99-1510
Study First Received: November 1, 1999
Last Updated: April 3, 2009
ClinicalTrials.gov Identifier: NCT00003819     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Genital Neoplasms, Male
Prostatic Diseases
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Urogenital Neoplasms
Genital Diseases, Male
Keyhole-limpet hemocyanin
Pharmacologic Actions
Neoplasms
Neoplasms by Site
QS 21
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 22, 2009