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| Sponsor: | Duke University |
|---|---|
| Information provided by: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00672152 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myelogenous Leukemia (AML) Chronic Myelogenous Leukemia (CML) Acute Lymphoblastic Leukemia (ALL) Myelodysplastic Syndrome (MDS) B Cell Malignancies |
Biological: WT1 derived peptides |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase I Study of WT1 Peptides to Induce Anti-Leukemia Immune Responses Following Autologous or Allogeneic Transplantation for AML, CmML, ALL, MDS, and B Cell Malignancies |
| Estimated Enrollment: | 15 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| A: Experimental |
Biological: WT1 derived peptides
WT1 derived peptides consisting of 0.3mg (cohort 1) or 1mg (cohort 2) of each of the following peptides mixed with 1ml Montanide ISA 51 and 100mcg GM-CSF in a total volume of 2ml:
Immunization with the peptide pools will be given as 200 microliter intradermal and 1.8ml subcutaneously in opposite thighs. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
For autologous transplants:
For allogeneic transplants,
We will require demonstration of >50% donor myeloid hematopoiesis, based on microsatellite polymorphisms, prior to enrolling the patients with MDS on the study.
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.
Exclusion Criteria:
Contacts and Locations| United States, North Carolina | |
| Duke Comprehensive Cancer Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Liz Anderson, RN, BSN, OCN 919-684-6342 ander094@mc.duke.edu | |
| Principal Investigator: Michael A Morse, MD | |
| Principal Investigator: | Michael A Morse, MD | Duke University |
| Study Director: | Amy Hobeika, PhD | Duke University |
| Principal Investigator: | Nelson Chao, MD | Duke University |
More Information
| Responsible Party: | Duke University Medical Center ( Michael Morse, M.D. ) |
| Study ID Numbers: | BB-IND 13254 |
| Study First Received: | May 4, 2008 |
| Last Updated: | January 13, 2010 |
| ClinicalTrials.gov Identifier: | NCT00672152 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Autologous transplantation Allogeneic transplantation |
|
Leukemia, Lymphoid Disease Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Precancerous Conditions Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Leukemia, Myeloid |
Leukemia, Myeloid, Acute Leukemia Lymphatic Diseases Neoplasms Preleukemia Pathologic Processes Syndrome Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases Lymphoproliferative Disorders |