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

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT00006483
Collaborator
National Cancer Institute (NCI) (NIH)
27
Enrollment
24
Locations
1
Arm
147
Duration (Months)
1.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: sargramostim
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study Of Aerosolized GM-CSF In The Treatment Of Metastatic Renal Cell Carcinoma To The Lung
Study Start Date :
Oct 1, 2000
Actual Primary Completion Date :
Jan 1, 2003
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Determine the 4-month progression-free survival rate [4 months]

Secondary Outcome Measures

  1. Determine the 4-month overall survival rate [4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

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

Sponsors and Collaborators

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

Investigators

  • Study Chair: Svetomir Markovic, MD, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00006483
Other Study ID Numbers:
  • NCCTG-N9953
  • CDR0000068314
First Posted:
Apr 29, 2004
Last Update Posted:
Jul 13, 2016
Last Verified:
Jul 1, 2016
Keywords provided by Alliance for Clinical Trials in Oncology
stage IV renal cell cancer
recurrent renal cell cancer
lung metastases
Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Sargramostim

Study Results

No Results Posted as of Jul 13, 2016