NCT00398138 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1
Status at capture: COMPLETED
Registry last update: 2016-03-02

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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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Safety

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outcome · POSTED

Immune Response

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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
healthy Volunteers: false
maximum Age: 120 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Biological: WT-1 analog peptide vaccine
Biological: incomplete Freund's adjuvant
Biological: sargramostim
Genetic: polymerase chain reaction
Other: flow cytometry
Other: immunoenzyme technique
label
vaccine
type
EXPERIMENTAL

interventions

arm Group Labels
vaccine
name
WT-1 analog peptide vaccine
type
BIOLOGICAL
arm Group Labels
vaccine
name
incomplete Freund's adjuvant
type
BIOLOGICAL
arm Group Labels
vaccine
name
sargramostim
type
BIOLOGICAL
arm Group Labels
vaccine
name
polymerase chain reaction
type
GENETIC
arm Group Labels
vaccine
name
flow cytometry
type
OTHER
arm Group Labels
vaccine
name
immunoenzyme technique
type
OTHER

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 22
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Toxicities will be tabulated according to the NCI Common Toxicity (version 3.0).
measure
Safety
time Frame
2 years
description
Immune reactivity to the peptides will be measured in the same fashion for patients with hematologic or thoracic malignancies. Immune responses will be measured by T cell proliferative response and DTH against WT-1 peptides. In patients with adequate samples, T cell gamma interferon release as measured by ELISPOT will be performed as well.
measure
Immune Response
time Frame
2 years

Full study description

brief 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.

Source references

references

citation
Maslak PG, Dao T, Krug LM, Chanel S, Korontsvit T, Zakhaleva V, Zhang R, Wolchok JD, Yuan J, Pinilla-Ibarz J, Berman E, Weiss M, Jurcic J, Frattini MG, Scheinberg DA. Vaccination with synthetic analog peptides derived from WT1 oncoprotein induces T-cell responses in patients with complete remission from acute myeloid leukemia. Blood. 2010 Jul 15;116(2):171-9. doi: 10.1182/blood-2009-10-250993. Epub 2010 Apr 16.
pmid
20400682
type
RESULT