Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00398138

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	Phase
Leukemia Lung Cancer Malignant Mesothelioma Myelodysplastic Syndromes 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	Phase I

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lung Cancer Mesothelioma Wilms' Tumor

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim Freund's adjuvant

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Thoracic and Myeloid Neoplasms

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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:	20
Study Start Date:	October 2006
Primary Completion Date:	November 2008 (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
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: NCT00398138

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Lee M. Krug, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000513334, MSKCC-06085
Study First Received:	November 9, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00398138 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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
peritoneal cavity cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Immunologic Factors
Precancerous Conditions
Leukemia, Myeloid, Acute
Leukemia
Acute Myelocytic Leukemia
Preleukemia
Acute Myeloid Leukemia, Adult
Respiratory Tract Diseases
Lung Neoplasms
Wilms' Tumor
Peritoneal Diseases
Neoplasm Metastasis
Wilms Tumor
Congenital Abnormalities

Digestive System Neoplasms
Hematologic Diseases
Myelodysplastic Syndromes
Adjuvants, Immunologic
Myeloproliferative Disorders
Leukemia, Myeloid
Abdominal Neoplasms
Recurrence
Carcinoma
Digestive System Diseases
Lung Diseases
Non-small Cell Lung Cancer
Mesothelioma
Gastrointestinal Neoplasms
Freund's Adjuvant

Additional relevant MeSH terms:

Thoracic Neoplasms
Immunologic Factors
Precancerous Conditions
Neoplasms, Mesothelial
Physiological Effects of Drugs
Leukemia, Myeloid, Acute
Leukemia
Preleukemia
Pathologic Processes
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Syndrome
Peritoneal Diseases
Respiratory Tract Neoplasms

Digestive System Neoplasms
Neoplasms by Histologic Type
Disease
Hematologic Diseases
Myelodysplastic Syndromes
Adjuvants, Immunologic
Leukemia, Myeloid
Abdominal Neoplasms
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases
Lung Diseases
Mesothelioma
Freund's Adjuvant

ClinicalTrials.gov processed this record on May 07, 2009