Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

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.

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.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

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.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Completion Date

Primary Completion Date

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

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 ^†

Study Chair:

Zihai Li, MD, PhD

University of Connecticut

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.