Kidney Cancer Clinical Trial

PEG-Interferon Alfa-2b, Sargramostim, and Thalidomide in Treating Patients With Metastatic Kidney Cancer

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 peripheral blood. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining PEG-interferon alfa-2b with sargramostim and thalidomide may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with sargramostim and thalidomide works in treating patients with metastatic kidney cancer.

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Full 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 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

10

Study ID:

NCT00090870

Recruitment Status:

Terminated

Sponsor:

Medical University of South Carolina

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There is 1 Location for this study

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Hollings Cancer Center at Medical University of South Carolina
Charleston South Carolina, 29425, United States

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

10

Study ID:

NCT00090870

Recruitment Status:

Terminated

Sponsor:


Medical University of South Carolina

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