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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00016120 |
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy and biological therapy in treating patients who have relapsed prostate cancer.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Globo H-GM2-Lewis-y-MUC1-32-mer-TF(c)-Tn(c)-KLH conjugate vaccine Drug: QS21 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Pilot Multivalent Conjugate Vaccine Trial For Patients With Biochemically Relapsed Prostate Cancer |
Study Start Date: | June 2000 |
OBJECTIVES:
OUTLINE: Patients receive Globo H, MUC-1-32mer, GM2, Lewis-y, Tn(c), TF(c)-KLH conjugate vaccine with adjuvant QS21 subcutaneously weekly on weeks 1, 2, 3, 7, 19, 31, 43, and 55.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 6 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Biochemically progressive disease after primary therapy, including surgery or radiotherapy, with or without neoadjuvant androgen ablation
Minimal baseline PSA value prior to study:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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 |
Study ID Numbers: | CDR0000068596, MSKCC-00064, NCI-G01-1940 |
Study First Received: | May 6, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00016120 |
Health Authority: | United States: Federal Government |
recurrent prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms QS 21 |
Genital Diseases, Male Prostatic Neoplasms Recurrence |
Neoplasms Neoplasms by Site |