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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
N/A
Open (Enrolling)
Both
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


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.

Inclusion 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

Surgery

- See Disease Characteristics

Other

- At least 4 weeks since prior bronchodialators

- No concurrent immunosuppressive agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Svetomir Markovic, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000068314

NCT ID:

NCT00006483

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

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - OchsnerNew Orleans, Louisiana  70121
CentraCare ClinicSaint Cloud, Minnesota  56303
Quain & Ramstad Clinic, P.C.Bismarck, North Dakota  58501
CCOP - Merit Care HospitalFargo, North Dakota  58122
Altru Health SystemsGrand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Central Plains Clinic, Ltd.Sioux Falls, South Dakota  57105