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

Metastatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006483
• Other study ID #: NCCTG-N9953
• Secondary ID: CDR0000068314
• Status: Completed
• Phase: Phase 2
• First received: November 6, 2000
• Last updated: July 12, 2016
• Start date: October 2000
• Est. completion date: January 2013

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 2013
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Biological:
• sargramostim

Locations

Country	Name	City	State
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	Saskatchewan Cancer Agency	Regina	Saskatchewan
United States	CCOP - Ann Arbor Regional	Ann Arbor	Michigan
United States	Quain & Ramstad Clinic, P.C.	Bismarck	North Dakota
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	CCOP - Duluth	Duluth	Minnesota
United States	CCOP - Merit Care Hospital	Fargo	North Dakota
United States	Altru Health Systems	Grand Forks	North Dakota
United States	CCOP - Ochsner	New Orleans	Louisiana
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	CentraCare Clinic	Saint Cloud	Minnesota
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	CCOP - Scottsdale Oncology Program	Scottsdale	Arizona
United States	Siouxland Hematology-Oncology	Sioux City	Iowa
United States	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota
United States	Central Plains Clinic, Ltd.	Sioux Falls	South Dakota
United States	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	CCOP - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the 4-month progression-free survival rate		4 months	No
Secondary	Determine the 4-month overall survival rate		4 months	No