Status:
TERMINATED
A Phase I Study of WT1 Peptides to Induce Anti-Leukemia Immune Responses Following Transplantation
Lead Sponsor:
Michael Morse, MD
Conditions:
Acute Myelogenous Leukemia (AML)
Chronic Myelogenous Leukemia (CML)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety and effectiveness of administering Wilms tumor gene 1 (WT1) cancer peptides. Cancer peptides are short pieces of protein that are made in a laborat...
Detailed Description
Two subgroups with 2 dose cohorts of up to 6 patients each will be enrolled in this exploratory study in order to attempt to obtain immunologic and clinical data on patients with a variety of hematolo...
Eligibility Criteria
Inclusion
- There are two subgroups of patients: Those undergoing autologous stem cell transplantation and those undergoing allogeneic stem cell transplantation.
- Autologous transplant subgroup:
- Patients with the following hematologic malignancies (AML, CML, ALL, B cell malignancies, and myelodysplastic syndrome) who will be undergoing autologous stem cell transplantation.
- Allogeneic transplantation subgroup:
- Patients with the following hematologic malignancies (AML, CML, ALL, B cell malignancies, and myelodysplastic syndrome) who have undergone allogeneic stem cell transplantation. There is no 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.
- Both subgroups:
- 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%.
- Age ≥ 18 years.
- Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines.
- 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:
- For autologous transplants:
- At least 2 weeks from prior chemotherapy.
- Injections 1 and 2 must be completed prior to administration of any growth factor mobilization
- Injections 3, 4, 5, and 6, to resume 2 or more weeks from the time of their stem cell infusion if there has been no 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.
- For allogeneic transplants,
- At least 2 weeks from the time of their 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 \>50% donor myeloid hematopoiesis, based on microsatellite polymorphisms, prior to enrolling the patients with MDS on the study.
- Adequate laboratory data as follows:
- Hematologic function: WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL (may transfuse or use erythropoietin to achieve this level), platelets ≥ 50,000/microliter ((may transfuse).
- Renal and hepatic function: serum creatinine \< 1.5 mg/dL, bilirubin \< 1.5 mg/dL (except a bilirubin of \<2.0 will be permitted for patents with Gilbert's syndrome), SGOT/SGPT \< 2 x upper limit of normal.
- Subjects must have a CD4+ count is \> 200/mm. There is no specified requirement for CD8+ T cell count.
- Urine protein/creatinine ratio (UPC) must be less than 1.
Exclusion
- 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+.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00672152
Start Date
June 1 2007
End Date
October 1 2013
Last Update
December 10 2013
Active Locations (1)
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1
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710