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

NCT00006483 | Completed Phase 2

• 2 other identifiers: NCCTG-N9953CDR0000068314
• Study Type: interventional
• Target: 27
• Locations: 2 countries
• Sites: 24

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.

Conditions

Kidney Cancer; Metastatic Cancer

Keywords

stage IV renal cell cancer; recurrent renal cell cancer; lung metastases

Outcome Measures

Primary Outcomes (1)

• Determine the 4-month progression-free survival rate

  4 months

Secondary Outcomes (1)

• Determine the 4-month overall survival rate

  4 months

Study Arms (1)

aerosolized sargramostim

EXPERIMENTAL

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

Interventions

sargramostim BIOLOGICAL

aerosolized sargramostim

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (24)

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CentraCare Clinic

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68131, United States

Location

Quain & Ramstad Clinic, P.C.

Bismarck, North Dakota, 58501, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Altru Health Systems

Grand Forks, North Dakota, 58201, United States

Location

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, 43623-3456, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57105-1080, United States

Location

Central Plains Clinic, Ltd.

Sioux Falls, South Dakota, 57105, United States

Location

Saskatchewan Cancer Agency

Regina, Saskatchewan, S4S 6X3, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

MeSH Terms

Conditions

Kidney Neoplasms; Neoplasm Metastasis; Carcinoma, Renal Cell

Interventions

sargramostim

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Svetomir Markovic, MD, PhD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2000
• First Posted: April 29, 2004
• Study Start: October 1, 2000
• Primary Completion: January 1, 2003
• Study Completion: January 1, 2013
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

CA (2); US (22)