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

Kidney Cancer Clinical Trial

Official title:

A Phase II Study Of Peg-Intron, GM-CSF And Thalidomide In Metastatic Renal Cell Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00090870
• Other study ID #: CDR0000378049
• Secondary ID: MUSC-100614CELGE
• Status: Terminated
• Phase: Phase 2
• Start date: April 2002
• Est. completion date: March 2010

Study information

• Verified date: June 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Biological:
• PEG-interferon alfa-2b
Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.
• GM-CSF
GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle

Drug:
• thalidomide
200mg daily by mouth

Locations

Country	Name	City	State
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate	To define the response rate in metastatic renal cell carcinoma patients receiving Peg-Intron, GM-CSF and thalidomide	while on study, every 4 cycles; while off study, every 3 months for 1 year, then every 6 month for 2 years, then every year
Secondary	Duration of Response		time from registration to the time of progressive disease among patients who achieve at least a partial response to treatment.
Secondary	Frequency of Adverse Events Assessed by NCI CTC Version 2		From the first day of treatment until the end of treatment visit, an average of 6 months
Secondary	Progression-free Survival		From registration until diease progression or death, whichever comes first.