Status:
COMPLETED
Wilm's Tumor 1 (WT1) Peptide Vaccine for High Risk Hematologic Malignancy
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Myelodysplastic Syndrome
Acute Myeloid Leukemia (AML)
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
This study will determine the safety and effectiveness of an experimental vaccine in controlling the abnormal growth of cells in patients with myelodysplastic syndrome (MDS, also known as myelodysplas...
Detailed Description
Leukemias and the related disorders myelodysplastic syndrome and myeloproliferative diseases represent a wide group of bone marrow stem cell malignancies. Some patients can be cured with chemotherapy ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Diagnosed with
- refractory anemia with excess of blasts (MDS-RAEB).
- or
- refractory anemia with excess of blasts in transformation (MDS-RAEBt).
- or
- secondary acute myelogenous leukemia (AML).
- or
- relapsed or refractory acute or chronic myelogenous leukemias (AML).
- or
- relapsed or refractory chronic myelogenous leukemias (CML) with accelerated phase or blast crisis
- or
- relapsed or refractory acute lymphoblastic leukemia (high risk ALL).
- or
- acute lymphoblastic leukemia (ALL) in complete remission.
- or
- chronic myelomonocytic leukemia (CMML).
- Unsuitable for stem cell transplantation (age over sixty or unavailability of a fully-matched donor).
- or
- made an informed decision not to undergo the transplant procedure.
- or
- relapsed AML, CML, MDS or ALL post stem cell transplantation (SCT).
- HLA-A0201 positive.
- Ages 18 - 85 years.
- Off all lympho-ablative chemotherapeutic agents.
- All subjects (men and women) must agree to practice abstinence or effective contraception during the study period.
- Inclusion Criteria Donor (for post transplant subjects without available donor lymphocyte infusion (DLI) cells):
- Related donor, HLA identical (6/6) with recipient.
- Age greater than or equal to 18 or less than or equal to 80 years old.
- Ability to comprehend the investigational nature of the study and provide informed consent.
- EXCLUSION CRITERIA:
- HIV positive (HIV-infected patients are immune-compromised and it is unlikely that these patients will be capable of mounting an immune response to the vaccine).
- Treatment with systemic corticosteroids within 7 days prior to study entry.
- Low bone marrow reserves (less than 20 percent cellularity).
- Serum creatinine greater than 2.5mg/dl or serum bilirubin greater than 4mg/dl (patients receiving fludarabine).
- Co-morbidity of such severity that it would preclude the patient's ability to tolerate protocol therapy.
- Predicted survival less than 3 months.
- Previous allergic reaction to Montanide Adjuvant.
- Pregnant or breast feeding (Pregnant and breast-feeding women are excluded from study because the effects of vaccination are not known and may pose a risk to the developing fetus. All female patients will have a urine pregnancy test, and only those that test negative will be allowed on study).
- Enrolled in another vaccine clinical trial during the study period.
- Inability to comprehend the investigational nature of the study and provide informed consent.
- Exclusion Criteria-Donor (any of the following):
- Pregnant or lactating.
- Unfit to receive filgrastim (G-CSF) and undergo apheresis (abnormal blood counts, history of stroke, uncontrolled hypertension).
- HIV positive.
- Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the bone marrow transplant (BMT) treatment unlikely and making informed consent impossible.
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00433745
Start Date
February 1 2007
End Date
November 1 2009
Last Update
July 8 2014
Active Locations (1)
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1
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, United States, 20892