Status:
TERMINATED
PEG-Interferon Alfa-2b, Sargramostim, and Thalidomide in Treating Patients With Metastatic Kidney Cancer
Lead Sponsor:
Medical University of South Carolina
Conditions:
Kidney Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripher...
Detailed Description
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 r...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00090870
Start Date
April 1 2002
End Date
March 1 2010
Last Update
July 12 2018
Active Locations (1)
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1
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425