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

Phase 2
18 Years
Open (Enrolling)
Kidney Cancer, Metastatic Cancer

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Trial Information

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


- 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

Inclusion Criteria


- 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

- No CNS metastases that require treatment



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 12 weeks


- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 75,000/mm^3

- Hemoglobin greater than 8.0 g/dL


- Bilirubin no greater than 2 times upper limit of normal (ULN)

- AST no greater than 3 times ULN


- Creatinine no greater than 2.5 times ULN


- No hemoptysis of grade 3 or greater

- No reactive airway disease on active therapy


- 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


Biologic therapy

- More than 2 weeks since prior immunotherapy

- More than 2 weeks since other prior biologic therapy


- 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


- More than 2 weeks since prior radiotherapy

- No prior radiotherapy to more than 10% of total lung volume in the radiation field


- See Disease Characteristics


- At least 4 weeks since prior bronchodialators

- No concurrent immunosuppressive agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Svetomir Markovic, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

October 2000

Completion Date:

Related Keywords:

  • Kidney Cancer
  • Metastatic Cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • lung metastases
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
CCOP - Duluth Duluth, Minnesota  55805
CCOP - Scottsdale Oncology Program Scottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
Siouxland Hematology-Oncology Sioux City, Iowa  51101-1733
CCOP - Ochsner New Orleans, Louisiana  70121
CentraCare Clinic Saint Cloud, Minnesota  56303
Quain & Ramstad Clinic, P.C. Bismarck, North Dakota  58501
CCOP - Merit Care Hospital Fargo, North Dakota  58122
Altru Health Systems Grand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology Program Toledo, Ohio  43623-3456
Rapid City Regional Hospital Rapid City, South Dakota  57709
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
Central Plains Clinic, Ltd. Sioux Falls, South Dakota  57105