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Vaccine Therapy Plus QS21 in Treating Patients With Progressive Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00003819
Recruitment Status : Completed
First Posted : April 27, 2004
Last Update Posted : March 19, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Prostate Cancer Biological: QS21 Biological: TF(c)-KLH conjugate vaccine Biological: Thomsen-Friedenreich antigen Biological: keyhole limpet hemocyanin Phase 1

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: 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
Study Start Date : June 1998
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: vaccine
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.
 Biological: QS21
Biological: TF(c)-KLH conjugate vaccine
Biological: Thomsen-Friedenreich antigen
Biological: keyhole limpet hemocyanin


Outcome Measures
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Primary Outcome Measures :
  1. response [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. safety [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Cancer Institute (NCI)
Investigators
Study Chair: Susan Slovin, MD, PhD Memorial Sloan Kettering Cancer Center
More Information
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00003819     History of Changes
Other Study ID Numbers: 98-048
P30CA008748 ( U.S. NIH Grant/Contract )
MSKCC-98048
NCI-G99-1510
First Posted: April 27, 2004    Key Record Dates
Last Update Posted: March 19, 2013
Last Verified: March 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
recurrent prostate cancer

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