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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: | NCT00016146 |
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 I trial to study the effectiveness in combining vaccine therapy and biological therapy in treating patients who have relapsed prostate cancer.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: GPI-0100 Drug: MUC-2-Globo H-KLH conjugate vaccine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Vaccination Of Prostate Cancer Patients With A Bivalent Vaccine Containing MUC-2 Glycopeptide And Globo H Conjugates: A Dose-Escalating Trial Studying The Immunogenicity And Safety Of The Immunological Adjuvant GPI-0100 |
Study Start Date: | July 2000 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of GPI-0100.
Patients receive glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant GPI-0100 subcutaneously weekly on weeks 0-2, 6, 14, and 26 in the absence of unacceptable toxicity or disease progression.
Cohorts of 5 patients receive escalating doses of GPI-0100 until the optimal dose, based on antibody response, is reached.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Biochemically progressive disease after primary surgery or radiotherapy with or without 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:
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: | CDR0000068598, MSKCC-99062, NCI-G01-1941 |
Study First Received: | May 6, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00016146 |
Health Authority: | United States: Federal Government |
recurrent prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Prostatic Neoplasms Recurrence |
Neoplasms Neoplasms by Site |