Vaccine Therapy and GM-CSF in Treating Patients With Low-Risk or Intermediate-Risk Myelodysplastic Syndrome

NCT00513578 | Unknown Phase 2

• 2 other identifiers: CDR0000558127VACCINE-PR1-204
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy together with GM-CSF may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with low-risk or intermediate-risk myelodysplastic syndrome.

Conditions

Myelodysplastic Syndromes

Keywords

refractory anemia with excess blasts; refractory anemia with ringed sideroblasts; refractory anemia; refractory cytopenia with multilineage dysplasia; de novo myelodysplastic syndromes; secondary myelodysplastic syndromes

Outcome Measures

Primary Outcomes (1)

• Immunologic response after four injections of vaccine formulation as determined by an increase in the absolute PR1-HLA-A2 tetramer count by at least 0.5/μl

Secondary Outcomes (2)

• Conversion of non-immunologic responders to immunologic responders by administering 4 additional doses of vaccine

• Clinical response as determined by modified IWG criteria

Interventions

PR1 leukemia peptide vaccine BIOLOGICAL

incomplete Freund's adjuvant BIOLOGICAL

sargramostim BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

• Diagnosis of myelodysplastic syndromes (MDS) and must meet all of the following criteria:
• FAB class refractory anemia (RA), RA with excess blasts (RAEB), or RA with ringed sideroblasts (RARS)
• WHO Classification RA, RARS, refractory cytopenia with multilineage dysplasia (RCMD), RCMD with ringed sideroblasts, or RAEB-1
• Less than 20% blasts on marrow aspirate
• IPSS risks groups intermediate-1- OR transfusion dependent low-risk
• Patients with de novo or therapy-related MDS eligible
• HLA-A2 positive at one allele

You may not qualify if:

• RAEB in transformation or RAEB-2
• Chloroma
• Marrow blasts on aspirate ≥ 20%
• Blood blasts \> 1%
• Inaspirable bone marrow
• History or current myelosclerosis occupying \> 30% of marrow space
• History of acute myeloid leukemia
• Other causes of cytopenia not related to MDS (i.e., gastrointestinal blood loss)
• PATIENT CHARACTERISTICS:
• ECOG performance status 0 or 1
• Women of childbearing potential must have a negative serum pregnancy test within 30 days of starting study drug
• Male or female of child-bearing potential must agree to use adequate contraceptive methods
• Serum bilirubin \< 2 mg/mL
• Creatinine ≤ 1.5 mg/mL
• ALT \< 2 times upper normal limit

Sponsors & Collaborators

• The Vaccine Company: lead

Study Sites (1)

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes; Anemia, Refractory, with Excess of Blasts; Anemia, Refractory

Interventions

incomplete Freund's adjuvant; sargramostim

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia

Study Officials

• Craig S. Rosenfeld, MD

  The Vaccine Company

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: August 8, 2007
• Study Start: January 1, 2007
• Primary Completion: January 1, 2009
• Last Updated: January 6, 2014

Record last verified: 2009-02

Locations

US (1)