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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Freund's Adjuvant; Sargramostim; Vaccines

Criteria

Inclusion Criteria:

• 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

• Patient or representative able to understand the study and consent

• Patient is not receiving steroids, cyclosporine, or FK-506 for at least 1 month prior to study entry and during study period

• No concomitant use of interferon or chemotherapy during study period other than hydroxyurea to control cell counts

• Patients who relapsed within one year of completing the initial vaccination could be retreated with up to 6 additional vaccinations if they remain eligible for treatment according to the original criteria