Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma
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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.
| Condition | Intervention |
|---|---|
|
Leukemia Lung Cancer Malignant Mesothelioma Myelodysplastic Syndromes Primary Peritoneal Cavity Cancer |
Biological: WT-1 analog peptide vaccine Biological: incomplete Freund's adjuvant Biological: sargramostim Genetic: polymerase chain reaction Other: flow cytometry Other: immunoenzyme technique |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Thoracic and Myeloid Neoplasms |
- Safety and immunogenicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Immune response as measured by T-cell proliferative response, delayed-type hypersensitivity against WT-1 peptides, or ELISPOT [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Antileukemic effects [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Clinical and molecular response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Antitumor response as measured by CT scan based on RECIST criteria [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Toxicity as measured by NCI CTC v. 3.0 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 22 |
| Study Start Date: | October 2006 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: vaccine
Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.
|
Biological: WT-1 analog peptide vaccine Biological: incomplete Freund's adjuvant Biological: sargramostim Genetic: polymerase chain reaction Other: flow cytometry Other: immunoenzyme technique |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Principal Investigator: | Lee M. Krug, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00398138 History of Changes |
| Other Study ID Numbers: | 06-085, P30CA008748, P01CA023766, MSKCC-06085 |
| Study First Received: | November 9, 2006 |
| Last Updated: | March 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
adult acute myeloid leukemia in remission adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) de novo myelodysplastic syndromes previously treated myelodysplastic syndromes |
secondary myelodysplastic syndromes recurrent non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer advanced malignant mesothelioma recurrent malignant mesothelioma primary peritoneal cavity cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Lung Neoplasms Mesothelioma Myelodysplastic Syndromes Preleukemia Peritoneal Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Neoplasms by Histologic Type Adenoma Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Freund's Adjuvant Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 23, 2013