Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic Myeloid Leukemia, Acute Myeloid Leukemia, or Myelodysplastic Syndrome - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00004918

Purpose

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: Sargramostim	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Acute Myeloid Leukemia Anemia Cancer Chronic Myeloid Leukemia Leukemia Myelodysplastic Syndromes

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim Montanide ISA 51

U.S. FDA Resources

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

Primary Outcome Measures:

Patient Immune response at 3 weeks after last vaccine [ Time Frame: 21 weeks (3 weeks post vaccine) ] [ Designated as safety issue: No ]
Patient Clinical response at 3 weeks after last vaccine [ Time Frame: 21 weeks (3 weeks post vaccine) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Event-free survival as measured by Kaplan-Meier at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Overall survival as measure by Kaplan-Meier at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	66
Study Start Date:	December 1999
Estimated Study Completion Date:	December 2012
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Vaccine + GM-CSF 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.	Biological: PR1 leukemia peptide vaccine Starting dose 0.25 mg 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, with escalating doses of vaccine until maximum tolerated dose (MTD) is determined. Phase II randomized to one of 3 dose levels of PR1 leukemia peptide vaccine with ISA-51 where patients in each of 3 arms receive treatment as in Phase I. Other Name: PR-1 peptide Biological: Sargramostim Administered as two separate 75 mcg injections in deep subcutaneous tissues in same region as peptide vaccine dose given. Other Name: GM-CSF

Arms

Assigned Interventions

Experimental: Vaccine + GM-CSF

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.

Biological: PR1 leukemia peptide vaccine

Starting dose 0.25 mg 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, with escalating doses of vaccine until maximum tolerated dose (MTD) is determined.

Phase II randomized to one of 3 dose levels of PR1 leukemia peptide vaccine with ISA-51 where patients in each of 3 arms receive treatment as in Phase I.

Other Name: PR-1 peptide

Biological: Sargramostim

Administered as two separate 75 mcg injections in deep subcutaneous tissues in same region as peptide vaccine dose given.

Other Name: GM-CSF

Detailed Description:

OBJECTIVES:

Determine the toxicity and immunological activity of PR1 leukemia peptide vaccine administered with Montanide ISA-51 in patients with chronic myeloid leukemia, acute myeloid leukemia, or myelodysplastic syndromes.
Evaluate possible clinical efficacy of this vaccine in high-risk HLA-A2-positive patients with myeloid leukemias.

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.

Eligibility

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

Criteria

Inclusion Criteria:

1) Diagnosis:CML in late chronic or early accelerated phase. MDS/AML not eligible for BMT,IFN, of failed standard therapy, or relapsed after BMT. All HLA A2+. ECOG PS<3. Life expectancy not limited by concomitant illness. Serum bilirubin<3 mg/dl, serum creatinine <2 mg/dl, no active uncontrolled infection, no effusion or ascites >1L prior to drainage. HIV negative. Not receiving steroids. NKA to incomplete Freund's Adjuvant (IFA). Pregnancy negative. Able to sign informed consent. Patients with immunological or clinical responses to PR1 vaccine may be retreated for disease progression.

Exclusion Criteria:

1) Any patient who does not meet Inclusion Criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004918

Locations

United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-1402

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:	Muzaffar H. Qazilbash, MD	M.D. Anderson Cancer Center
Study Chair:	Richard E. Champlin, MD	M.D. Anderson Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

UT MD Anderson Cancer Center Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00004918 History of Changes
Other Study ID Numbers:	DM97-325, R01CA081247, P30CA016672, MDA-DM-97325, NCI-T98-0017, CDR0000067600
Study First Received:	March 7, 2000
Last Updated:	October 17, 2011
Health Authority:	United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

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, BCR-ABL negative
myelodysplastic/myeloproliferative neoplasm, 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)

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders

Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on February 13, 2012