Peptide Vaccinations to Treat Patients With Low-Risk Myeloid Cancers
Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML)
About this trial
This is an interventional treatment trial for Myelodysplastic Syndrome (MDS) focused on measuring Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), Wilm's Tumor-1, Proteinase-3, Myelodysplastic Syndrome, MDS, Acute Myeloid Leukemia, AML, Chronic Myeloid Leukemia, CML
Eligibility Criteria
- INCLUSION CRITERIA:
Diagnosed with MDS (B subtypes Refractory anemia (RA), Refractory anemia with ring sideroblasts (RARS) -Low Risk) (MDS with 5q- must have failed lenalidomide or been ineligible to receive it)
OR
Diagnosed with AML and in complete remission within 5 years of treatment with less than 5% marrow blasts
OR
Diagnosed with CML in chronic phase
Unsuitable for stem cell transplantation (SCT) (age over sixty or unavailability of a fully-matched donor)
or
made an informed decision not to undergo the transplant procedure
or
are between 6 months 3 years following allogeneic SCT and fulfill the following criteria:
100% donor engraftment,
Less than 5% blasts in marrow
normal marrow cellularity
Human leukocyte antigen (HLA-A020 1) positive at one allele
Ages 18-85 years old
Off all lympho-ablative chemotherapeutic agents
EXCLUSION CRITERIA:
- Hypoplastic MDS
- Relapsed AML
- CML in accelerated phase or blast crisis
- Hypocellular bone marrow (less than 20%)
- History of Wegener's granulomatosis
- Serologic antibody against proteinase-3 (ANCA positive)
- Previous allergic reaction to Montanide Adjuvant
- Positive test for HIV
- Treatment with systemic corticosteroids or immunosuppressants within 14 days prior to study entry
- Co-morbidity of such severity that it would preclude the patient's ability to tolerate protocol therapy
- Predicted survival less than 28 days
- Pregnant or breast feeding (All female patients must have a urine pregnancy test within 1 week prior to vaccine administration)
- Unwilling to practice abstinence or effective contraception (men and women) during the study period.
- Enrolled in another drug or vaccine clinical trial during the study period
- Inability to comprehend the investigational nature of the study and provide informed consent
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Arms of the Study
Arm 1
Experimental
PR1/WT1 Vaccine Response in Participants With Low-Risk Myeloid Cancers
Subjects were given 6 subcutaneous injects of PR1:169-177 in "Montanide" adjuvant and 6 subcutaneous injections of WT1:126-134 in "Montanide" adjuvant at 2 weekly intervals. GM-CSF (Sargramostim) was co administered with each vaccine dose. Subjects with immunological response to one or both peptide vaccines had the option of receiving a maximum of 6 additional boosters of the WT-1:126-134 and PR1:169-177 peptide vaccines at 3 monthly intervals.