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

NCT ID: NCT00090870

Last Updated: 2018-07-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2010-03-31

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 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.

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 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.

Conditions

Kidney Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PEG-Intron, BM-CSF and thalidomide

Group Type: EXPERIMENTAL

PEG-interferon alfa-2b

Intervention Type: BIOLOGICAL

Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.

GM-CSF

Intervention Type: BIOLOGICAL

GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle

thalidomide

Intervention Type: DRUG

200mg daily by mouth

Interventions

PEG-interferon alfa-2b

Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.

Intervention Type: BIOLOGICAL

GM-CSF

GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle

Intervention Type: BIOLOGICAL

thalidomide

200mg daily by mouth

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uzair B. Chaudhary, MD

Role: STUDY_CHAIR

Medical University of South Carolina

Gustavo Leone

Role: STUDY_CHAIR

Medical University of South Carolina, Hollings Cancer Center

Locations

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

MUSC-100614

Identifier Type: -

Identifier Source: secondary_id

CELGENE-MUSC-100614

Identifier Type: -

Identifier Source: secondary_id

MUSC-HR-10423

Identifier Type: -

Identifier Source: secondary_id

CDR0000378049

Identifier Type: -

Identifier Source: org_study_id