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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004918 |
RATIONALE: Vaccines made from peptides that are found on leukemia cells may make the body build an immune response and kill cancer cells. Combining vaccine therapy with the immune adjuvant Montanide ISA-51 may be a more effective treatment for chronic myeloid leukemia, acute myeloid leukemia, or myelodysplastic syndrome.
PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy when given with Montanide ISA-51 and to see how well they work in treating patients with chronic myeloid leukemia, acute myeloid leukemia, or myelodysplastic syndrome.
Condition | Intervention | Phase |
---|---|---|
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Biological: PR1 leukemia peptide vaccine Biological: incomplete Freund's adjuvant Biological: sargramostim |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase I/II Study of PR1 (NSC 698102) Human Leukemia Peptide Vaccine With Montanide ISA 51 (NSC 675756) or Montanide ISA 51 VG (NSC 737063) Adjuvant |
Estimated Enrollment: | 66 |
Study Start Date: | December 1999 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a phase I dose-escalation study of PR1 leukemia peptide vaccine, followed by a phase II randomized study.
Patients receive PR1 leukemia peptide vaccine with Montanide ISA-51 (ISA-51) subcutaneously (SC) once every 3 weeks for 18 weeks, for a total of 6 vaccinations. Patients also receive sargramostim (GM-CSF) SC with each vaccination.
Cohorts of 3 patients receive escalating doses of PR1 leukemia peptide vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity.
Additional patients are accrued to the phase II portion of the study and are randomized to receive one of three dose levels of PR1 leukemia peptide vaccine with ISA-51. Patients in each of the 3 arms receive treatment as in the phase I portion of the study.
Patients achieving a clinical response and/or clinical response to the vaccine whose disease progresses within 6-12 months after the first set of vaccinations may receive additional vaccine as before.
Patients achieving a clinical response or immune reaction to the vaccine are followed at least monthly until death or until the clinical response and/or immune reaction is lost.
PROJECTED ACCRUAL: A total of 3-9 patients will be accrued for the phase I dose escalation portion of this study. A maximum of 60 patients (20 per arm) will be accrued for the phase II randomized portion of this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of chronic myeloid leukemia in chronic phase or early accelerated phase
Diagnosis of 1 of the following diseases and not a candidate for chemotherapy:
Myelodysplastic syndromes in second or subsequent remission
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Texas | |
M.D. Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-1402 |
Study Chair: | Muzaffar H. Qazilbash, MD | M.D. Anderson Cancer Center |
Investigator: | Richard E. Champlin, MD | M.D. Anderson Cancer Center |
Responsible Party: | M. D. Anderson Cancer Center at University of Texas ( Muzaffar H. Qazilbash ) |
Study ID Numbers: | CDR0000067600, MDA-DM-97325, NCI-T98-0017 |
Study First Received: | March 7, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004918 History of Changes |
Health Authority: | United States: Federal Government |
relapsing chronic myelogenous leukemia chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia adult acute myeloid leukemia in remission refractory anemia with excess blasts refractory anemia with excess blasts in transformation previously treated myelodysplastic syndromes |
atypical chronic myeloid leukemia myelodysplastic/myeloproliferative disease, unclassifiable adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with t(15;17)(q22;q12) |
Immunologic Factors Precancerous Conditions Leukemia, Myeloid, Chronic-Phase Leukemia, Myeloid, Acute Refractory Anemia Leukemia Preleukemia Acute Myelocytic Leukemia Anemia, Refractory Acute Myeloid Leukemia, Adult Congenital Abnormalities Myelodysplastic Myeloproliferative Disease Hematologic Diseases |
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Myelodysplastic Syndromes Anemia Myeloproliferative Disorders Adjuvants, Immunologic Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myelogenous, Chronic, BCR-ABL Positive Freund's Adjuvant Anemia, Refractory, with Excess of Blasts Chronic Myelogenous Leukemia Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases |
Disease Neoplasms by Histologic Type Immunologic Factors Precancerous Conditions Hematologic Diseases Physiological Effects of Drugs Myelodysplastic Syndromes Adjuvants, Immunologic Myeloproliferative Disorders Leukemia, Myeloid Leukemia, Myeloid, Acute |
Pharmacologic Actions Leukemia Preleukemia Neoplasms Pathologic Processes Syndrome Leukemia, Myelogenous, Chronic, BCR-ABL Positive Freund's Adjuvant Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases |