NCT00030303

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 leukemia

Timeline
Completed

Started Jan 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2002

Completed
12 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

3 years

First QC Date

February 14, 2002

Last Update Submit

April 26, 2017

Conditions

Leukemia

Keywords

chronic phase chronic myelogenous leukemiachronic myelogenous leukemia, BCR-ABL1 positive

Study Arms (1)

vaccine

EXPERIMENTAL

recombinant 70-kD heat-shock protein

Biological: recombinant 70-kD heat-shock protein

Interventions

recombinant 70-kD heat-shock proteinBIOLOGICAL
vaccine

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030-1601, United States

Location

Related Publications (1)

  • 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.

    PMID: 15958631RESULT

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Chronic-PhaseLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

HSP70 Heat-Shock Proteins

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heat-Shock ProteinsMolecular ChaperonesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Zihai Li, MD, PhD

    UConn Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2002

First Posted

January 27, 2003

Study Start

January 1, 2001

Primary Completion

January 1, 2004

Study Completion

January 1, 2004

Last Updated

April 28, 2017

Record last verified: 2017-04

Locations

US(1)