Synthetic Vaccine in Patients With Chronic Myeloid Leukemia and Minimal Residual Disease
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
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
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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:
- 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:
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, 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 May 16, 2013