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

Information source: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Cancer; Metastatic Cancer

Intervention: sargramostim (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: Alliance for Clinical Trials in Oncology

Official(s) and/or principal investigator(s):
Svetomir Markovic, MD, PhD, Study Chair, Affiliation: Mayo Clinic

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.

Clinical Details

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

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

Primary outcome: Determine the 4-month progression-free survival rate

Secondary outcome: Determine the 4-month overall survival rate

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

CCOP - Scottsdale Oncology Program, Scottsdale, Arizona 85259-5404, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois 61602, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa 52403-1206, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309-1016, United States

Siouxland Hematology-Oncology, Sioux City, Iowa 51101-1733, United States

CCOP - Wichita, Wichita, Kansas 67214-3882, United States

CCOP - Ochsner, New Orleans, Louisiana 70121, United States

CCOP - Ann Arbor Regional, Ann Arbor, Michigan 48106, United States

CCOP - Duluth, Duluth, Minnesota 55805, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

CentraCare Clinic, Saint Cloud, Minnesota 56303, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota 55416, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68131, United States

Quain & Ramstad Clinic, P.C., Bismarck, North Dakota 58501, United States

CCOP - Merit Care Hospital, Fargo, North Dakota 58122, United States

Altru Health Systems, Grand Forks, North Dakota 58201, United States

CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio 43623-3456, United States

CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania 17822-2001, United States

Allan Blair Cancer Centre, Regina, Saskatchewan S4T 7T1, Canada

Saskatchewan Cancer Agency, Regina, Saskatchewan S4S 6X3, Canada

Rapid City Regional Hospital, Rapid City, South Dakota 57709, United States

CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota 57105-1080, United States

Central Plains Clinic, Ltd., Sioux Falls, South Dakota 57105, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: October 2000
Last updated: July 7, 2015

Page last updated: August 23, 2015

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