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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | May 4, 2008 | ||||||||||||
| Last Updated Date | January 13, 2010 | ||||||||||||
| Start Date ICMJE | June 2007 | ||||||||||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
To determine the safety and feasibility of administering WT1 peptides to subjects who have undergone autologous or allogeneic stem cell transplantation for AML, CML, ALL, B cell malignancies and myelodysplastic syndrome. [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT00672152 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | 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 | ||||||||||||
| Official Title ICMJE | 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 | ||||||||||||
| Brief Summary | 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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| Detailed Description | |||||||||||||
| Study Phase | Phase I | ||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Control: Dose Comparison Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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. |
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| Study Arms / Comparison Groups | A: Experimental
Intervention: Biological: WT1 derived peptides |
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| Publications * | |||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 15 | ||||||||||||
| Estimated Completion Date | June 2010 | ||||||||||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | 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,
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:
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| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | |||||||||||||
| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00672152 | ||||||||||||
| Responsible Party | Michael Morse, M.D., Duke University Medical Center | ||||||||||||
| Study ID Numbers ICMJE | BB-IND 13254 | ||||||||||||
| Study Sponsor ICMJE | Duke University | ||||||||||||
| Collaborators ICMJE | |||||||||||||
| Investigators ICMJE |
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| Information Provided By | Duke University | ||||||||||||
| Verification Date | January 2010 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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