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Tracking Information | |||||
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First Received Date † | February 14, 2002 | ||||
Last Updated Date | February 6, 2009 | ||||
Start Date † | January 2001 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00030303 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia | ||||
Official Title † | A Feasibility And Toxicity Study Of Vaccination With HSP70 For The Treatment Of Chronic Myelogenous Leukemia In Chronic Phase | ||||
Brief Summary | RATIONALE: Vaccines made from a person's white blood cells may make the body build an immune response to kill cancer cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have chronic myelogenous leukemia. |
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Detailed Description | OBJECTIVES:
OUTLINE: Patients undergo leukapheresis to obtain peripheral mononuclear cells (PMNCs). Heat shock protein 70 (HSP70) is derived from the autologous PMNCs. Patients receive HSP70 intradermally once weekly for 8 weeks. Patients are followed for 2 weeks. PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study. |
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Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment | ||||
Condition † | Leukemia | ||||
Intervention † | Biological: recombinant 70-kD heat-shock protein | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* 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 † | Active, not recruiting | ||||
Enrollment † | |||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00030303 | ||||
Responsible Party | |||||
Secondary IDs †† | UCHC-01117, UCHC-7659, NCI-V01-1685 | ||||
Study Sponsor † | University of Connecticut | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | March 2003 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |