Synthetic Vaccine in Patients With Chronic Myeloid Leukemia and Minimal Residual Disease - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	BreakThrough Therapeutics
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00267085

Purpose

The goal of this clinical research study is to learn if giving 1 of 2 CML (Chronic Myeloid Leukemia) vaccines (CML-VAX B2 or CML-VAX B3) together with imatinib mesylate can decrease or eliminate all evidence of disease in patients who have CML that is in remission after treatment with imatinib mesylate, but who still have small amounts of detectable disease.

Condition	Intervention	Phase
Chronic Myeloid Leukemia Minimal Residual Disease	Biological: Synthetic Tumor-Specific Breakpoint Peptide Vaccine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Pilot Phase II Trial of a Synthetic Tumor-Specific Breakpoint Peptide Vaccine in Patients With Chronic Myeloid Leukemia (CML) and Minimal Residual Disease

Resource links provided by NLM:

MedlinePlus related topics: Cancer Chronic Myeloid Leukemia Leukemia

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Response: One Log Decrease in BCR-ABL [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Molecular response defined as reduction by one log of the circulating peripheral blood for reverse transcription polymerase chain reaction (RT-PCR) transcripts of BCR-ABL (tumor-specific oncogenic fusion protein) after two consecutive measurements. RT-PCR performed at 3 month intervals. Response categorized as either 'No Decrease' or 'Decrease' if one log reduction in BCR-ABL detected.

Enrollment:	11
Study Start Date:	December 2005
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CML Vaccine Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, then monthly for 10 months	Biological: Synthetic Tumor-Specific Breakpoint Peptide Vaccine CML vaccine, Imatinib mesylate, subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, then monthly for 10 months Other Name: Imatinib mesylate

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with Ph chromosome positive or BCR-ABL-positive CML (as determined by cytogenetics, FISH, or RT-PCR).
Patients must have reached their 18th birthday.
Patients must have received imatinib therapy for at least 12 months and must not have had changes in their dose of imatinib in the last 6 months. Patients must not have had a continuous interruption of imatinib therapy of greater than 14 days or for a total of 6 weeks in the 6 months prior to enrollment.
Patients must be in complete cytogenetic remission confirmed by two marrows, the second being at least one month after the first.
Patients must have detectable BCR-ABL transcript levels that are not more than 0.5-log lower than the lowest value obtained in the last 6 months, with at least two values obtained during this period.
Karnofsky performance status should be > 70.
Adequate organ function defined as: bilirubin <2x upper limit of normal (ULN), creatinine <1.5x ULN, and ALT and AST <2.5x ULN.
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Women of childbearing potential (i.e., not post-menopausal 24 months or not surgically sterile) must agree to use effective methods of contraception.

Exclusion Criteria:

Patients with a history of accelerated or blast crisis. Accelerated phase is defined as 15 to 30% blasts or >30% blasts plus promyelocytes in the peripheral blood or marrow, >20% basophils, or platelets <100 x 10^9/L, unrelated to therapy. Cytogenetic abnormalities in addition to the Ph chromosome are not considered a defining feature of accelerated phase.
Patients with autoimmune disorders or known immune deficiency.
Patients receiving immunosuppressive therapy, corticosteroids, chemotherapy, or therapy for CML other than imatinib.
Patients receiving any other investigational agents.
Patients who are pregnant or breast-feeding.
Patients with clinically significant heart disease (New York Heart Association Class III or IV) or other serious intercurrent illnesses, active uncontrolled infections requiring antibiotics or active bleeding.
Patients who have undergone major surgery within 28 days before registration, or who have not fully recovered from any other prior major surgery.
Patients who have undergone stem cell transplantation.
Patients who have received radiation therapy within 4 weeks of enrollment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267085

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

BreakThrough Therapeutics

Investigators

Principal Investigator:

Jorge E. Cortes, M.D.

M.D. Anderson Cancer Center

More Information

Additional Information:

M.D. Anderson's Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Jorge Cortes M.D./Professor, The University of Texas M. D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00267085 History of Changes
Obsolete Identifiers:	NCT00392600
Other Study ID Numbers:	2005-0392
Study First Received:	December 19, 2005
Results First Received:	September 24, 2009
Last Updated:	January 28, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Chronic Myeloid Leukemia
Minimal Residual Disease
Peptide Vaccine

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases

Neoplastic Processes
Pathologic Processes
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012