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Synthetic Vaccine in Patients With Chronic Myeloid Leukemia and Minimal Residual Disease

This study has been completed.
Sponsor:
Collaborator:
BreakThrough Therapeutics
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00267085
First received: December 19, 2005
Last updated: August 1, 2012
Last verified: August 2012
  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 2

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:


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

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. Patients with Ph chromosome positive or BCR-ABL-positive CML (as determined by cytogenetics, FISH, or RT-PCR).
  2. Patients must have reached their 18th birthday.
  3. 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.
  4. Patients must be in complete cytogenetic remission confirmed by two marrows, the second being at least one month after the first.
  5. 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.
  6. Karnofsky performance status should be > 70.
  7. Adequate organ function defined as: bilirubin <2x upper limit of normal (ULN), creatinine <1.5x ULN, and ALT and AST <2.5x ULN.
  8. 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.
  9. 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:

  1. 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.
  2. Patients with autoimmune disorders or known immune deficiency.
  3. Patients receiving immunosuppressive therapy, corticosteroids, chemotherapy, or therapy for CML other than imatinib.
  4. Patients receiving any other investigational agents.
  5. Patients who are pregnant or breast-feeding.
  6. 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.
  7. Patients who have undergone major surgery within 28 days before registration, or who have not fully recovered from any other prior major surgery.
  8. Patients who have undergone stem cell transplantation.
  9. Patients who have received radiation therapy within 4 weeks of enrollment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: 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: August 1, 2012
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, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Neoplasm, Residual
Bone Marrow Diseases
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes
Imatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014