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

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 2

Conditions: Metastatic Cancer; Kidney Cancer

Treatments: Biological: sargramostim

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00006483

CDR0000068314 (Registry Identifier)

NCCTG-N9953

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

aerosolized sargramostim

Experimental group

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.

Treatment:

Biological: sargramostim