Expired Study
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Peoria, Illinois 61602


Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

NCCTG-N9953


NCT ID:

NCT00006483


Secondary ID:

CDR0000068314


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Alliance for Clinical Trials in Oncology


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Maski


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

27


Enrollment Type:

Actual


Overall Contact Information

Official Name:Svetomir Markovic, MD, PhD
Study Chair
Mayo Clinic

Study Dates

Start Date:October 2000
Completion Date:January 2013
Completion Type:Actual
Primary Completion Date:January 2003
Primary Completion Type:Actual
Verification Date:July 2016
Last Changed Date:July 12, 2016
First Received Date:November 6, 2000

Study Outcomes

Outcome Type:Primary Outcome
Measure:Determine the 4-month progression-free survival rate
Time Frame:4 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Determine the 4-month overall survival rate
Time Frame:4 months
Safety Issues:False

Study Interventions

Intervention Type:Biological
Name:sargramostim
Arm Name:aerosolized sargramostim

Study Arms

Study Arm Type:Experimental
Arm Name:aerosolized sargramostim
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Alliance for Clinical Trials in Oncology
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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