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Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
recombinant 70-kD heat-shock protein
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring chronic phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Connecticut Health Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

vaccine

Arm Description

recombinant 70-kD heat-shock protein

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 14, 2002
Last Updated
April 26, 2017
Sponsor
UConn Health
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1. Study Identification

Unique Protocol Identification Number
NCT00030303
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2001 (Actual)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
January 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UConn Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
chronic phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vaccine
Arm Type
Experimental
Arm Description
recombinant 70-kD heat-shock protein
Intervention Type
Biological
Intervention Name(s)
recombinant 70-kD heat-shock protein

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zihai Li, MD, PhD
Organizational Affiliation
UConn Health
Official's Role
Study Chair
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-1601
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15958631
Citation
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.
Results Reference
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Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia

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