NCT00398138

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

Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Thoracic and Myeloid Neoplasms

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Leukemia
• Lung Cancer
• Malignant Mesothelioma
• Myelodysplastic Syndromes
• Primary Peritoneal Cavity Cancer

Interventions

Type	Name	Description
BIOLOGICAL	WT-1 analog peptide vaccine
BIOLOGICAL	incomplete Freund's adjuvant
BIOLOGICAL	sargramostim
GENETIC	polymerase chain reaction
OTHER	flow cytometry
OTHER	immunoenzyme technique

Timeline

• Start date: 2006-10-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2006-11-10
• Last updated: 2016-03-02
• Results posted: 2016-03-02

Locations

1 site across 1 country: United States