A Phase I Study of WT1 Peptides to Induce Anti-Leukemia Immune Responses Following Transplantation

Stopped early · Phase 1

Conditions studied: Acute Myelogenous Leukemia (AML), Chronic Myelogenous Leukemia (CML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS), B Cell Malignancies

In brief

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 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 Granulocyte-macrophage colony-stimulating factor (GM-CSF) which may help make the immune response stronger.

Key facts

Study ID

NCT00672152

Run by

Michael Morse, MD

People needed

8

Starts

2007-06-01

Expected to finish

2013-10-01

Last updated by the study team

2013-12-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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+.

Where it is running

• Duke Comprehensive Cancer Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.