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CompletedPhase 1NCT00398138
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedWT-1 analog peptide vaccine and incomplete Freund's adjuvant

Plus 4 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Mesothelioma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 2, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Memorial Sloan Kettering Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Memorial Sloan Kettering Cancer Center
Interventions being studied
Biological: WT-1 analog peptide vaccine; Biological: incomplete Freund's adjuvant; Biological: sargramostim; Genetic: polymerase chain reaction; Other: flow cytometry; Other: immunoenzyme technique
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→Mesothelioma→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Memorial Sloan Kettering Cancer CenterNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 2, 2016. Always confirm current availability with the study team.

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