Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Biological: recombinant 70-kD heat-shock protein |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Feasibility And Toxicity Study Of Vaccination With HSP70 For The Treatment Of Chronic Myelogenous Leukemia In Chronic Phase |
| Study Start Date: | January 2001 |
OBJECTIVES:
- 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.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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
Contacts and Locations| United States, Connecticut | |
| University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06030-1601 | |
| Study Chair: | Zihai Li, MD, PhD | University of Connecticut Health Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00030303 History of Changes |
| Other Study ID Numbers: | CDR0000069127, UCHC-01117, UCHC-7659, NCI-V01-1685 |
| Study First Received: | February 14, 2002 |
| Last Updated: | June 4, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
chronic phase chronic myelogenous leukemia chronic myelogenous leukemia, BCR-ABL1 positive |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type |
Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013