CompletedPhase 1NCT00017121

Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung

RATIONALE: Inhaling sargramostim may interfere with the growth of tumor cells and may be an effective treatment for melanoma that has spread to the lung. PURPOSE: This phase I trial is studying the side effects and best dose of inhaled sargramostim in treating patients with melanoma that is metastatic to the lung.

Checked against the public recordLast updated Jul 6, 2016 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations87
SponsorAlliance for Clinical Trials in Oncology
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Alliance for Clinical Trials in Oncology
Interventions being studied
Biological: sargramostim
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

DISEASE CHARACTERISTICS: * Histologically confirmed metastatic melanoma to the lung for which no known standard therapy exists * At least 1 unidimensionally measurable lesion * HLA-A2 positive (part A patients only) * Previously treated CNS metastases allowed provided there is no evidence of disease progression within the past 3 months PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 75,000/mm\^3 * Hemoglobin at least 8.0 g/dL Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * AST no greater than 3 times ULN Renal: * Creatinine no greater than 2.5 times ULN Cardiovascular: * No New York Heart Association class III or IV heart disease Pulmonary: * No pulmonary disease requiring concurrent active therapy (e.g., supplemental oxygen or bronchodilator) * FEV\_1 at least 65% of predicted and at least 1.5 L Immunologic: * No known immunodeficiency state * No known autoimmune disease * No uncontrolled infection Other: * No active psychotic disorder requiring pharmacotherapy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * More than 2 weeks since prior biologic therapy * More than 2 weeks since prior immunotherapy * More than 4 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF) * No other concurrent biologic therapy or immunotherapy * No concurrent G-CSF * No concurrent GM-CSF other than study drug Chemotherapy: * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * No concurrent chemotherapy Endocrine therapy: * More than 2 weeks since prior corticosteroids * No concurrent glucocorticosteroids Radiotherapy: * More than 2 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * Not specified Other: * More than 7 days since prior parenteral antibiotics * No concurrent parenteral antibiotics * No concurrent immunosuppressive agents

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

  • Mayo Clinic ScottsdaleScottsdale, Arizona
  • Mayo Clinic - JacksonvilleJacksonville, Florida
  • Rush-Copley Cancer Care CenterAurora, Illinois
  • St. Joseph Medical CenterBloomington, Illinois
  • Graham HospitalCanton, Illinois
  • Memorial HospitalCarthage, Illinois
  • Eureka Community HospitalEureka, Illinois
  • Galesburg ClinicGalesburg, Illinois
  • Galesburg Cottage HospitalGalesburg, Illinois
  • Mason District HospitalHavana, Illinois
  • Hopedale Medical ComplexHopedale, Illinois
  • Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 6, 2016. Always confirm current availability with the study team.

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