Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia
NCT ID: NCT00030303
Last Updated: 2017-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2001-01-31
2004-01-31
Brief Summary
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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
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* Determine the feasibility of vaccination with autologous heat shock protein 70 in patients with chronic phase chronic myelogenous leukemia.
* Determine the toxicity of this vaccination in these patients.
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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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vaccine
recombinant 70-kD heat-shock protein
recombinant 70-kD heat-shock protein
Interventions
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recombinant 70-kD heat-shock protein
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of chronic phase chronic myelogenous leukemia
* Philadelphia chromosome positive
* Peripheral blast count no greater than 10%
* No molecular remission
* Less than 3 years since initial diagnosis
* No anticipation of requirement for bone marrow or stem cell transplantation for 6 months
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Hemoglobin at least 10 g/dL
* Platelet count at least 20,000/mm\^3
Hepatic:
* Bilirubin less than 2.0 times upper limit of normal (ULN)
* Transaminase less than 2.0 times ULN
Renal:
* Creatinine less than 2.0 mg/dL
Other:
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No significant active infection requiring hospitalization
* No other serious illness or significant behavioral or psychological problem that would preclude study involvement
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
* Prior interferon alfa allowed
* No concurrent interferon alfa
Chemotherapy:
* Prior cytarabine or other cytotoxic agents allowed
* No concurrent cytarabine or other cytotoxic agents
* Concurrent hydroxyurea allowed
Endocrine therapy:
* No concurrent corticosteroid therapy
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* No concurrent immunosuppressive medications
* Concurrent imatinib mesylate allowed
18 Years
120 Years
ALL
No
Sponsors
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UConn Health
OTHER
Responsible Party
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Principal Investigators
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Zihai Li, MD, PhD
Role: STUDY_CHAIR
UConn Health
Locations
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University of Connecticut Health Center
Farmington, Connecticut, United States
Countries
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References
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Li Z, Qiao Y, Liu B, Laska EJ, Chakravarthi P, Kulko JM, Bona RD, Fang M, Hegde U, Moyo V, Tannenbaum SH, Menoret A, Gaffney J, Glynn L, Runowicz CD, Srivastava PK. Combination of imatinib mesylate with autologous leukocyte-derived heat shock protein and chronic myelogenous leukemia. Clin Cancer Res. 2005 Jun 15;11(12):4460-8. doi: 10.1158/1078-0432.CCR-05-0250.
Other Identifiers
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CDR0000069127
Identifier Type: REGISTRY
Identifier Source: secondary_id
UCHC-7659
Identifier Type: -
Identifier Source: secondary_id
NCI-V01-1685
Identifier Type: -
Identifier Source: secondary_id
UCHC-01117
Identifier Type: -
Identifier Source: org_study_id
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