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Mesothelioma Related Clinical Trials:
Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Thoracic and Myeloid Neoplasms
- General Info - Purpose - Eligibility - Contacts & Locations - Additional Information
Status: Recruiting
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center, National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
Government Identifier: NCT00398138
Condition: Leukemia; Lung Cancer; Malignant Mesothelioma; Myelodysplastic Syndromes; Peritoneal Cavity Cancer
Intervention: Drug: WT-1 analog peptide vaccine; Drug: incomplete Freund's adjuvant; Drug: sargramostim; Procedure: diagnostic procedure; Procedure: flow cytometry; Procedure: immunoenzyme technique; Procedure: non-specific immune-modulator therapy; Procedure: non-tumor cell-derivative vaccine therapy; Procedure: polymerase chain reaction
Purpose:
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill cancer cells. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop cancer cells from growing. Giving vaccine therapy together with GM-CSF may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects of vaccine therapy and GM-CSF in treating patients with acute myeloid leukemia, myelodysplastic syndromes, non-small cell lung cancer, or mesothelioma.
| Study Type: Â | Interventional |
| Study Design: Â | Treatment |
| Official Title: Â | Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Thoracic and Myeloid Neoplasms |
- Safety and immunogenicity [ Designated as safety issue: Yes ]
- Immune response as measured by T-cell proliferative response, delayed-type hypersensitivity against WT-1 peptides, or ELISPOT [ Designated as safety issue: No ]
- Antileukemic effects [ Designated as safety issue: No ]
- Clinical and molecular response [ Designated as safety issue: No ]
- Antitumor response as measured by CT scan based on RECIST criteria [ Designated as safety issue: No ]
- Toxicity as measured by NCI CTC v. 3.0 [ Designated as safety issue: Yes ]
| Estimated Enrollment: Â | 20 |
| Study Start Date: Â | October 2006 |
| Estimated Primary Completion Date: Â | October 2010 (Final data collection date for primary outcome measure) |
Detailed Description:
OBJECTIVES:
Primary
- Determine the safety and immunogenicity of the Wilms tumor-1 analog peptide vaccine in patients with acute myeloid leukemia, myelodysplastic syndromes, non-small cell lung cancer, or mesothelioma.
Secondary
- Determine the antitumor effects of this vaccine in these patients.
OUTLINE: This is a pilot study. Patients are stratified according to disease type (acute myeloid leukemia [AML] or myelodysplastic syndromes [MDS] vs non-small cell lung cancer or mesothelioma).
Patients receive vaccine comprising Wilms-tumor 1 (WT-1) analog peptide emulsified in Montanide ISA-51 subcutaneously (SC) once in weeks 0, 4, 6, 8, 10, and 12 and sargramostim (GM-CSF) SC twice in weeks 0, 4, 6, 8, 10, and 12 (on the day of and 2 days prior to each vaccination). Patients who have an immunologic response and have no disease progression may receive up to 6 more vaccinations approximately 1 month apart.
Blood samples are collected at baseline, week 8, and week 14. Samples are examined by polymerase chain reaction (PCR) to measure levels of WT-1 and by T-cell proliferative response, delayed-type hypersensitivity against WT-1 peptides, or ELISPOT to measure immune response.
Bone marrow samples are collected from patients with AML or MDS at baseline and week 14. Samples are examined by PCR to measure levels of WT-1 and by multiparameter flow cytometry to measure residual disease.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Eligibility:
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
-
Cytologically or histologically confirmed diagnosis of 1 of the following:
- Acute myeloid leukemia, meeting the following criteria:
- Documented Wilms tumor-1 (WT-1)-positive disease demonstrated by WT-1 protein on a pretreatment bone marrow biopsy OR detectable disease with real-time quantitative reverse transcriptase-polymerase chain reaction (RQ-PCR)
- Completed induction chemotherapy, achieved clinical remission, and completed postremission therapy OR achieved clinical remission and have no plans for further postremission chemotherapy (≥ 65 years of age)
- Myelodysplastic syndromes, meeting the following criteria:
- Documented WT-1-positive disease demonstrated by WT-1 protein on a pretreatment bone marrow biopsy OR detectable disease by RQ-PCR
- International Prognostic Scoring System (IPSS) score of ≥ Int-2
- Not a candidate for cytotoxic chemotherapy
- Non-small cell lung cancer, meeting the following criteria:
- Positive tumor staining for WT-1 in > 10% of cells
- Stage III or IV disease
- Completed chemotherapy, surgery, and/or radiotherapy
- Mesothelioma, meeting the following criteria:
- Positive tumor staining for WT-1 in > 10% of cells
- Unresectable or relapsed disease
- Chemo-naive or received 1 prior chemotherapy regimen
- Malignant pleural mesothelioma or peritoneal mesothelioma
- Acute myeloid leukemia, meeting the following criteria:
- No leptomeningeal disease
- No CNS involvement
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Absolute neutrophil count ≥ 1,000/mm³
- Platelet count > 50,000/mm³ (except for myelodysplastic syndromes where parameter is > 20,000/mm³ and not transfusion dependent)
- Bilirubin ≤ 2.0 mg/dL
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine ≤ 2.0 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection requiring systemic antibiotics, antiviral, or antifungal treatments
- No serious unstable medical illness
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy or radiotherapy
- No concurrent systemic corticosteroids
Contacts and Locations:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398138Locations
| United States, New York | |||||
| Memorial Sloan - Kettering Cancer Center   | Recruiting | ||||
| Â Â Â New York, New York, United States, 10021 | |||||
| Â Â Â Contact: Lee M. Krug, MD Â Â 212-639-8420 Â Â Â Â | |||||
Sponsors and Collaborators
| Memorial Sloan-Kettering Cancer Center |
| National Cancer Institute (NCI) |
Investigators
| Principal Investigator:   | Lee M. Krug, MD   | Memorial Sloan-Kettering Cancer Center   |
Additional Information:
| Study ID Numbers: Â | CDR0000513334, MSKCC-06085 |
| First Received: Â | November 9, 2006 |
| Last Updated: Â | December 25, 2007 |
| ClinicalTrials.gov Identifier: Â | NCT00398138 |
| Health Authority: Â | Unspecified |
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