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| Tracking Information | |||||
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| First Received Date ICMJE | May 13, 2002 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | March 2002 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00036933 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Vaccine Therapy Plus QS21 in Treating Patients With Prostate Cancer | ||||
| Official Title ICMJE | Vaccination Of Prostate Cancer Patients With A Bivalent Vaccine Containing MUC-2 Glycopeptide And Globo H Conjugates Plust The Immunological Adjuvant QS21 | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00036933 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000069342, MSKCC-01140, NCI-G02-2064 | ||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | March 2003 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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