Status:
COMPLETED
Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Innovive Pharmaceuticals
Conditions:
Leukemia
Lung Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
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 way...
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 canc...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00398138
Start Date
October 1 2006
End Date
June 1 2009
Last Update
March 2 2016
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065