Study Using Vaccination With Heat Shock Protein 70 (HSP70) for the Treatment of CML in Chronic Phase

NCT00027144 | Completed Phase 1

• 1 other identifier: 01-117
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Description: The trial is designed to determine the response of the immune system of patients with CML to a vaccine made from their own tumor. Researchers believe that this particular vaccine, which is made from purified heat shock proteins taken from each patient's tumor, alerts the body's immune system to recognize and attack invading cancer. To be considered potentially eligible for this study you must have CML in the chronic phase. Length/Duration: Vaccinations will be administered weekly for eight weeks. One clinic follow up visit will be scheduled two weeks after the final vaccination.

Conditions

Leukemia,Myeloid, Chronic; Leukemia,Myeloid,Philadelphia-Positive

Keywords

Leukemia; Vaccine

Interventions

Heat Shock Protein 70 HSP70 BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG Performance Score(PS) less than 2.
• Must be at least 18 years of age and capable of giving informed consent.
• Must be less than three years from the original diagnosis of Philadelphia chromosome positive CML in chronic phase.
• Patient is not in cytogenetic remission.
• No anticipation of bone marrow or stem cell transplant for six months unless these therapies are deemed necessary by a treatment physician due to the evolution of the disease;
• Concurrent treatment with hydroxyurea or Gleevec is allowed.PAST treatment with IFN alpha, Ara-C or other cytoxic agents is allowed
• Must not have any serious illness such that their medical condition might be compromised by participation in the study.
• Must have adequate renal function (serum creatinine \< 2.0), hepatic function (bilirubin and transaminase less than 2.0 x of the upper normal limit).
• Must not be on corticosteroid therapy, or other immunosuppressive medications.

You may not qualify if:

• Patients with an ECOG Performance Score greater than or equal to 2.
• Patient is greater than or equal to 3 years out from the original diagnosis.
• Significant anemia (Hemoglobin \< 10 g/dl) and thrombocytopenia (platelet \< 20,000/ml) requiring transfusion.
• Peripheral blast count is over 10%.
• Positive urine or blood pregnancy test.
• Impaired renal function (serum creatinine \> 2.0), hepatic function (bilirubin and transaminase more than 2.0 x of the upper normal limit).
• Patient with significant active infection requiring hospitalization at the time of enrollment.
• Patient with significant behavioral or psychological problems that prevent adequate follow-up.
• Concurrent treatment with IFN alpha Ara-C or other cytotoxic agents (Gleevec and hydroxyurea are allowed.

Sponsors & Collaborators

• University of Connecticut: lead

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Related Links

• UConn Web Page

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia

Interventions

HSP70 Heat-Shock Proteins

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heat-Shock Proteins; Molecular Chaperones; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Zihai Li, MD,Ph.D.

  Assistant Professor Medicine and Tumor Immunology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 27, 2001
• First Posted: November 28, 2001
• Study Start: December 1, 2000
• Study Completion: October 1, 2002
• Last Updated: June 24, 2005

Record last verified: 2001-11

Locations

US (1)