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

A Phase II Study Of Aerosolized GM-CSF In The Treatment Of Metastatic Renal Cell Carcinoma 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.

Study Overview

• Status: Completed
• Conditions: Kidney Cancer; Metastatic Cancer
• Intervention / Treatment: Biological: sargramostim

Detailed Description

OBJECTIVES:

• Determine the 4-month progression-free survival rate and overall survival rate in patients with metastatic renal cell carcinoma to the lung treated with aerosolized sargramostim (GM-CSF).
• Determine the toxicity of this regimen in these patients.
• Determine the immunomodulatory effects of this regimen in terms of natural killer cells cytotoxicity, and T-cell, B-cell, and dendritic cell activation markers.

OUTLINE: This is a multicenter study.

Patients receive aerosolized sargramostim (GM-CSF) by nebulizer over 10-15 minutes twice daily on days 1-7 and 14-21. Treatment repeats every 28 days in the absence of disease progression or unaceptable toxicity.

Patients are followed for disease progression and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 21-48 patients will be accrued for this study within 7-20 months.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Allan Blair Cancer Centre
    • Regina, Saskatchewan, Canada, S4S 6X3
      • Saskatchewan Cancer Agency
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259-5404
      • CCOP - Scottsdale Oncology Program
  • Illinois
    • Peoria, Illinois, United States, 61602
      • CCOP - Illinois Oncology Research Association
    • Urbana, Illinois, United States, 61801
      • CCOP - Carle Cancer Center
  • Iowa
    • Cedar Rapids, Iowa, United States, 52403-1206
      • CCOP - Cedar Rapids Oncology Project
    • Des Moines, Iowa, United States, 50309-1016
      • CCOP - Iowa Oncology Research Association
    • Sioux City, Iowa, United States, 51101-1733
      • Siouxland Hematology-Oncology
  • Kansas
    • Wichita, Kansas, United States, 67214-3882
      • CCOP - Wichita
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • CCOP - Ochsner
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • CCOP - Ann Arbor Regional
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • CCOP - Duluth
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Cancer Center
    • Saint Cloud, Minnesota, United States, 56303
      • CentraCare Clinic
    • Saint Louis Park, Minnesota, United States, 55416
      • CCOP - Metro-Minnesota
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • CCOP - Missouri Valley Cancer Consortium
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Quain & Ramstad Clinic, P.C.
    • Fargo, North Dakota, United States, 58122
      • CCOP - Merit Care Hospital
    • Grand Forks, North Dakota, United States, 58201
      • Altru Health Systems
  • Ohio
    • Toledo, Ohio, United States, 43623-3456
      • CCOP - Toledo Community Hospital Oncology Program
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822-2001
      • CCOP - Geisinger Clinic and Medical Center
  • South Dakota
    • Rapid City, South Dakota, United States, 57709
      • Rapid City Regional Hospital
    • Sioux Falls, South Dakota, United States, 57105-1080
      • CCOP - Sioux Community Cancer Consortium
    • Sioux Falls, South Dakota, United States, 57105
      • Central Plains Clinic, Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: aerosolized sargramostim; Patients receive aerosolized sargramostim (GM-CSF) by nebulizer over 10-15 minutes twice daily on days 1-7 and 14-21. Treatment repeats every 28 days in the absence of disease progression or unaceptable toxicity. Patients are followed for disease progression and then every 3 months thereafter.	Biological: sargramostim

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determine the 4-month progression-free survival rate	4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Determine the 4-month overall survival rate	4 months

Collaborators and Investigators

• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: October 1, 2000
• Primary Completion (Actual): January 1, 2003
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: November 6, 2000
• First Submitted That Met QC Criteria: April 28, 2004
• First Posted (Estimate): April 29, 2004

Study Record Updates

• Last Update Posted (Estimate): July 13, 2016
• Last Update Submitted That Met QC Criteria: July 12, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: stage IV renal cell cancer; recurrent renal cell cancer; lung metastases
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Physiological Effects of Drugs; Immunologic Factors; Sargramostim
• Other Study ID Numbers: NCCTG-N9953; CDR0000068314 (Registry Identifier: PDQ (Physician Data Query))