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

NCT00004918 | Completed Phase 1

• 2 other identifiers: NCI-2012-03086DM 97-325
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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

Conditions

Accelerated Phase Chronic Myelogenous Leukemia; Adult Acute Myeloid Leukemia in Remission; Chronic Phase Chronic Myelogenous Leukemia; Previously Treated Myelodysplastic Syndromes; Refractory Anemia With Excess Blasts; Refractory Anemia With Excess Blasts in Transformation; Relapsing Chronic Myelogenous Leukemia

Outcome Measures

Primary Outcomes (6)

• Adverse event DTOX (death or autoimmune toxicity or vascular toxicity at any time) assessed using Common Toxicity Criteria (CTC) version 2.0

  Up to 8 years

• Ability of dose

  Regression analyses will be performed.

  Up to 8 years

• T cell receptor (TCR) activity

  Regression analyses will be performed.

  Up to 8 years

• Clinical response

  Regression analyses will be performed.

  Up to 8 years

• Duration of first immune response (IR)

  Will be assessed using logistic regression.

  Up to 8 years

• Survival time

  Will be assessed using a Cox model or similar event time model

  Up to 8 years

Study Arms (3)

Arm I (dose level 1 PR1 leukemia peptide vaccine)

EXPERIMENTAL

Patients receive dose level 1 of PR1 leukemia peptide vaccine with Montanide ISA-51 SC once every 3 weeks for 18 weeks, for a total of 6 vaccinations. Patients also receive GM-CSF SC with each vaccination.

Biological: PR1 leukemia peptide vaccine; Drug: Montanide ISA 51 VG; Biological: sargramostim; Other: laboratory biomarker analysis

Arm II (dose level 2 PR1 leukemia peptide vaccine)

EXPERIMENTAL

Patients receive dose level 2 of PR1 leukemia peptide vaccine with Montanide ISA-51 SC once every 3 weeks for 18 weeks, for a total of 6 vaccinations. Patients also receive GM-CSF SC with each vaccination.

Biological: PR1 leukemia peptide vaccine; Drug: Montanide ISA 51 VG; Biological: sargramostim; Other: laboratory biomarker analysis

Arm III (dose level 3 PR1 leukemia peptide vaccine)

EXPERIMENTAL

Patients receive dose level 3 of PR1 leukemia peptide vaccine with Montanide ISA-51 SC once every 3 weeks for 18 weeks, for a total of 6 vaccinations. Patients also receive GM-CSF SC with each vaccination.

Biological: PR1 leukemia peptide vaccine; Drug: Montanide ISA 51 VG; Biological: sargramostim; Other: laboratory biomarker analysis

Interventions

PR1 leukemia peptide vaccine BIOLOGICAL

Given SC

Also known as: PR1 vac, proteinase 3 PR1 peptide

Arm I (dose level 1 PR1 leukemia peptide vaccine); Arm II (dose level 2 PR1 leukemia peptide vaccine); Arm III (dose level 3 PR1 leukemia peptide vaccine)

Montanide ISA 51 VG DRUG

Given SC

Arm I (dose level 1 PR1 leukemia peptide vaccine); Arm II (dose level 2 PR1 leukemia peptide vaccine); Arm III (dose level 3 PR1 leukemia peptide vaccine)

sargramostim BIOLOGICAL

Given SC

Also known as: GM-CSF, Leukine, Prokine

Arm I (dose level 1 PR1 leukemia peptide vaccine); Arm II (dose level 2 PR1 leukemia peptide vaccine); Arm III (dose level 3 PR1 leukemia peptide vaccine)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (dose level 1 PR1 leukemia peptide vaccine); Arm II (dose level 2 PR1 leukemia peptide vaccine); Arm III (dose level 3 PR1 leukemia peptide vaccine)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be HLA-A2 positive at one allele
• Patients with CML in chronic phase or early accelerated phase, who are not eligible for BMT or interferon, or have failed standard therapy, or have relapsed after BMT
• Patients with MDS (FAB subtypes RAEB, and RAEBt) or AML in second or subsequent remission, or AML with a smoldering presentation and who are not candidates for chemotherapy, and who are believed to have a life expectancy of at least 9 weeks
• ECOG performance status \< 3
• Life expectancy is not severely limited by concomitant illness
• Serum bilirubin \< 3 mg/dl
• Serum creatinine \< 2 mg/dl
• ALT \< 3 x the upper limit of normal
• No serologic antibody against proteinase 3
• No known history of Wegener's granulomatosis or other vasculitis
• FEV, FVC, and DLCO \> 50% of predicted, and no symptomatic pulmonary disease
• Not pregnant; all female patients will have a serum pregnancy test, and only those that test negative will be allowed on study
• HIV negative
• No known allergic reaction to Montanide ISA 51 or Montanide ISA 51 VG adjuvant
• No active uncontrolled infection

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Accelerated Phase; Leukemia, Myeloid, Chronic-Phase; Anemia, Refractory, with Excess of Blasts

Interventions

montanide ISA 51; sargramostim; Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia, Refractory; Anemia; Myelodysplastic Syndromes

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Muzaffar Qazilbash

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2000
• First Posted: January 27, 2003
• Study Start: December 1, 1999
• Primary Completion: December 1, 2007
• Last Updated: January 7, 2013

Record last verified: 2013-01

Locations

US (1)