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


N/A
18 Years
N/A
Not Enrolling
Both
Leukemia, Lung Cancer, Malignant Mesothelioma, Myelodysplastic Syndromes, Primary Peritoneal Cavity Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and immunogenicity

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Lee M. Krug, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

06-085

NCT ID:

NCT00398138

Start Date:

October 2006

Completion Date:

June 2009

Related Keywords:

  • Leukemia
  • Lung Cancer
  • Malignant Mesothelioma
  • Myelodysplastic Syndromes
  • Primary Peritoneal Cavity Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Lung Neoplasms
  • Mesothelioma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Peritoneal Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021