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A Feasibility And Toxicity Study Of Vaccination With HSP70 For The Treatment Of Chronic Myelogenous Leukemia In Chronic Phase


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Leukemia

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Trial Information

A Feasibility And Toxicity Study Of Vaccination With HSP70 For The Treatment Of Chronic Myelogenous Leukemia In Chronic Phase


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Zihai Li, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Connecticut Health Center

Authority:

United States: Federal Government

Study ID:

CDR0000069127

NCT ID:

NCT00030303

Start Date:

January 2001

Completion Date:

Related Keywords:

  • Leukemia
  • chronic phase chronic myelogenous leukemia
  • chronic myelogenous leukemia, BCR-ABL1 positive
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

University of Connecticut Health CenterFarmington, Connecticut  06360-7106