Phase 1
N=12
Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma
Leukemia · Lung Cancer · Malignant Mesothelioma · Myelodysplastic Syndromes · Primary Peritoneal Cavity Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00398138 ↗Enrolled (actual)
12
Serious AEs
30.0%
Results posted
Mar 2016
Primary outcome: Primary: Safety — 10 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- WT-1 analog peptide vaccine (Biological); incomplete Freund's adjuvant (Biological); sargramostim (Biological); polymerase chain reaction (Genetic); flow cytometry (Other); immunoenzyme technique (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety |
10 | — |
| PRIMARY Immune Response |
10 | — |
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 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.
Eligibility 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
- 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
Data sourced from ClinicalTrials.gov (NCT00398138). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.