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

Sponsors and Collaborators:	M.D. Anderson Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
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: incomplete Freund's adjuvant Biological: sargramostim	Phase I Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Sargramostim Montanide ISA 51 Freund's adjuvant

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Immune response at 3 weeks after last vaccine [ Designated as safety issue: No ]
Clinical response at 3 weeks after last vaccine [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Estimated Enrollment:	66
Study Start Date:	December 1999
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

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

DISEASE CHARACTERISTICS:

Diagnosis of chronic myeloid leukemia in chronic phase or early accelerated phase
- Ineligible for bone marrow transplantation (BMT) or interferon OR
- Failed standard therapy OR
- Relapsed after BMT OR
Diagnosis of 1 of the following diseases and not a candidate for chemotherapy:
- Myelodysplastic syndromes in second or subsequent remission
  - Refractory anemia with excess blasts (RAEB) OR
  - RAEB in transformation
- Acute myeloid leukemia (AML) in second or subsequent remission
- AML with a smoldering presentation
HLA-A2 positive at one allele

PATIENT CHARACTERISTICS:

Age:

Over 18

Performance status:

ECOG 0-2

Life expectancy:

At least 9 weeks

Hematopoietic:

Not specified

Hepatic:

Bilirubin less than 3 mg/dL
ALT less than 3 times upper limit of normal

Renal:

Creatinine less than 2 mg/dL

Pulmonary:

FEV, FVC, and DLCO greater than 50% of predicted
No symptomatic pulmonary disease

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other concurrent illness that severely limits life expectancy
No known history of Wegener's granulomatosis or other vasculitis
No known allergy to Montanide ISA-51
No active uncontrolled infection
No serologic antibody against proteinase 3
HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

See Disease Characteristics
No concurrent interferon

Chemotherapy:

See Disease Characteristics
No concurrent chemotherapy except hydroxyurea to control cell counts

Endocrine therapy:

At least 1 month since prior steroids
No concurrent steroids

Radiotherapy:

Not specified

Surgery:

Not specified

Other:

At least 1 month since prior cyclosporine or tacrolimus
No concurrent cyclosporine or tacrolimus

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
Investigator:	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

No publications provided

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

Keywords provided by National Cancer Institute (NCI):

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)

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 07, 2009