CompletedPhase 2NCT00006483

Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung

RATIONALE: Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may be an effective treatment for patients with kidney cancer that has spread to the lung. PURPOSE: Phase II trial to study the effectiveness of sargramostim in treating patients who have kidney cancer that has spread to the lung.

Checked against the public recordLast updated Jul 13, 2016 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations24
SponsorAlliance for Clinical Trials in Oncology
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
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 renal cell carcinoma for which no known standard therapy that is potentially curative or capable of extending life expectancy exists (e.g., surgery) * Measurable metastatic disease in the lung * At least one unidimensionally measurable lesion at least 20 mm by conventional techniques * No CNS metastases that require treatment 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 greater than 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 Pulmonary * No hemoptysis of grade 3 or greater * No reactive airway disease on active therapy Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled infection * No other metastatic malignancy within the past 3 years except basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * More than 2 weeks since prior immunotherapy * More than 2 weeks since other prior biologic therapy Chemotherapy * More than 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) Endocrine therapy * More than 2 weeks since prior corticosteroids * No concurrent systemic glucocorticoids Radiotherapy * More than 2 weeks since prior radiotherapy * No prior radiotherapy to more than 10% of total lung volume in the radiation field Other * At least 4 weeks since prior bronchodialators * 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

  • CCOP - Scottsdale Oncology ProgramScottsdale, Arizona
  • CCOP - Illinois Oncology Research AssociationPeoria, Illinois
  • CCOP - Carle Cancer CenterUrbana, Illinois
  • CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa
  • CCOP - Iowa Oncology Research AssociationDes Moines, Iowa
  • Siouxland Hematology-OncologySioux City, Iowa
  • CCOP - WichitaWichita, Kansas
  • CCOP - OchsnerNew Orleans, Louisiana
  • CCOP - Ann Arbor RegionalAnn Arbor, Michigan
  • CCOP - DuluthDuluth, Minnesota
  • Mayo Clinic Cancer CenterRochester, Minnesota
  • CentraCare ClinicSaint Cloud, Minnesota

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 13, 2016. Always confirm current availability with the study team.

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