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View Clinical Trial (Medical Research Study)
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A Phase I Study of WT1 Peptides to Induce Anti-Leukemia Immune Responses Following Autologous or Allogeneic Transplantation for AML, CML, ALL, MDS, and B Cell Malignancies - NCT00672152-27710 (Clinical Trial 218821)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy218821.aspx
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| City: |
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Durham |
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State:
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NC |
| Zip Code: |
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27710 |
| Conditions: |
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Acute Myelogenous Leukemia (AML) - Chronic Myelogenous Leukemia (CML) - Acute Lymphoblastic Leukemia (ALL) - Myelodysplastic Syndrome (MDS) - B Cell Malignancies |
| Purpose: |
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The purpose of this study is to determine the safety and effectiveness of administering WT1
cancer peptides. Cancer peptides are short pieces of protein that are made in a laboratory
to be like the peptides that can be found in cancer. These peptides are intended to be
given as a "vaccine" to activate the immune cells in a person to attack his/her cancer.
These peptides are mixed with an oily substance called Montanide ISA-51 and a white cell
growth factor called GM-CSF which may help make the immune response stronger.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Patients with the following hematologic malignancies (AML, CML, ALL, B cell
malignancies, and Myelodysplastic syndrome) who have undergone autologous or
allogeneic stem cell transplantation. There is not limitation on whether
myeloablative or non-myeloablative chemotherapy is administered. A 3/6 or greater
match is required for patients who have had an allogeneic stem cell transplant.
- Subject must be one of the following HLA types: HLA A2, A24, DR15 or DRw53 (includes
HLA-DR4, -DR7, and DRw9).
- Karnofsky performance status must be greater than or equal to 70%.
- Patient must agree to use adequate contraception defined as: for women, one of the
following (1) surgical sterilization, (2) approved hormonal contraceptives (such as
birth control pills, Depo-Provera, or Lupron Depot), (3) barrier methods (such as a
condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD); for
men, one of the following: (1) surgical sterilization, or (2) a condom used with a
spermicide.
- In order to receive their immunizations, subjects should be:
- At least 2 weeks from the time of their allogeneic stem cell infusion.
- Without Grade 3 or 4 non-hematologic major organ toxicity within the preceding 1
week; non major organ toxicities must have resolved to grade 2 or less.
- We will require demonstration of greater than or equal to 50% donor myeloid
hematopoiesis, based on microsatellite polymorphisms, prior to enrolling patients
with MDS on the study.
- Adequate laboratory data as follows: Hematologic function: WBC ≥ 3000/microliter,
hemoglobin ≥ 9g/dL (may transfuse or use erythropoietin to achieve this level),
platelets ≥50,000/microliter (may transfuse); Renal and hepatic function: serum
creatinine < 1.5mg/dL, bilirubin < 1.5mg/dL (except a bilirubin of < 2.0 will be
permitted for patients with Gilbert's syndrome), SGOT/SGPT ≤ 2 x upper limit of
normal.
- Subjects must have a CD4+ count ≥ 200/mm. There is no specified requirement for CD8+
T cell count.
- Urine protein/creatinine ratio (UPC) must be less than 1.
Exclusion Criteria:
- Corticosteroid (greater than 10mg per day of prednisone or an equipotent dose of
another corticosteroid) or other immunosuppressive therapy within the prior 1 week.
- Pregnant women and nursing mothers.
- Current or prior history of brain metastases.
- More than 12 months since their stem cell transplant.
- HIV +, hepatitis BsAg +, Hepatitis C Ab+. |
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| Study is available at: |
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Duke Comprehensive Cancer Center
Durham, NC 27710
United States
Primary Contact:
Liz Anderson, RN, BSN, OCN
Email: ander094@mc.duke.edu
Phone: 919-668-6406 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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