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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00036933 |
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. Combining vaccine therapy with QS21 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with QS21 in treating patients who have prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: MUC-2-Globo H-KLH conjugate vaccine Biological: QS21 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Vaccination Of Prostate Cancer Patients With A Bivalent Vaccine Containing MUC-2 Glycopeptide And Globo H Conjugates Plust The Immunological Adjuvant QS21 |
| Study Start Date: | March 2002 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant QS21 subcutaneously once weekly on weeks 0-2, 6, 14, and 26 in the absence of unacceptable toxicity. Patients whose antibody titers against Globo-H or MUC-2 antigens fall below 1/40 and who have no disease progression may receive a seventh vaccination after week 50.
Patients are followed every 3 months for 1 year or until biochemical relapse or radiographic disease progression.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 2 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Disease progression after primary surgery (radical prostatectomy) or radiotherapy with or without prior neoadjuvant androgen ablation
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Susan Slovin, MD, PhD | Memorial Sloan-Kettering Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00036933 History of Changes |
| Other Study ID Numbers: | CDR0000069342, MSKCC-01140, NCI-G02-2064 |
| Study First Received: | May 13, 2002 |
| Last Updated: | December 3, 2009 |
| Health Authority: | United States: Federal Government |
|
stage III prostate cancer recurrent prostate cancer |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male |
Prostatic Diseases Adjuvants, Immunologic QS 21 Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |