A Phase II Study Of Peg-Intron, GM-CSF And Thalidomide In Metastatic Renal Cell Carcinoma
18 Years
N/A
Both
Kidney Cancer
Trial Information
A Phase II Study Of Peg-Intron, GM-CSF And Thalidomide In Metastatic Renal Cell Carcinoma
OBJECTIVES:
Primary
- Determine the response to PEG-interferon alfa-2b, sargramostim (GM-CSF), and
thalidomide in patients with metastatic renal cell carcinoma.
Secondary
- Determine duration of response in patients treated with this regimen.
- Determine the tolerance to and toxicity of this regimen in these patients.
- Determine the median and progression-free survival of patients treated with this
regimen.
OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously (SC) on days 1 and 8,
sargramostim (GM-CSF) SC on days 1-10, and oral thalidomide once daily on days 1-21. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed renal cell carcinoma
- Metastatic disease
- Measurable disease
- Unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm
by spiral CT scan or MRI
- Histologic confirmation required if measurable disease is confined to a
solitary lesion
- The following are not considered measurable disease:
- Bone disease only
- Pleural or peritoneal metastases
- CNS lesions
- Irradiated lesions unless disease progression was documented after prior
radiotherapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 mg/dL
- No decompensated liver disease
Renal
- Creatinine ≤ 2.0 mg/dL
Immunologic
- No known or suspected hypersensitivity to interferon alfa or to any excipient or
vehicle included in the formulation or delivery system
- No history of autoimmune disease
- No autoimmune hepatitis
- No immunosuppressed transplantation recipients
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 effective methods of contraception 4 weeks before,
during, and for 4 weeks after study participation
- No pre-existing thyroid abnormalities for which thyroid function cannot be maintained
in the normal range
- No severe psychiatric condition or disorder, including suicidal ideation or attempt
- No other active malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior immunotherapy
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy
Surgery
- Not specified
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response
Safety Issue:
No
Principal Investigator
Uzair B. Chaudhary, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Medical University of South Carolina
Authority:
United States: Federal Government
Study ID:
CDR0000378049
NCT ID:
NCT00090870
Start Date:
April 2002
Completion Date:
March 2010
Related Keywords:
- Kidney Cancer
- stage IV renal cell cancer
- Carcinoma, Renal Cell
- Kidney Neoplasms
Name | Location |
|---|---|
| Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
