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

Phase 2

Terminated

• Conditions: Kidney Cancer
• Interventions: Biological: PEG-interferon alfa-2b; Biological: GM-CSF; Drug: thalidomide

• Registration Number: NCT00090870
• Lead Sponsor: Medical University of South Carolina

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.

Study Timeline

• Study Start: 2002-04
• Study First Submitted: 2004-09-07
• Study First Submitted QC: 2004-09-07
• Study First Posted: 2004-09-08
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2018-05-04
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-13
• Last Update Submitted: 2018-06-13
• Results First Posted: 2018-07-12
• Last Update Posted: 2018-07-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEG-Intron, BM-CSF and thalidomide	PEG-interferon alfa-2b	-
PEG-Intron, BM-CSF and thalidomide	GM-CSF	-
PEG-Intron, BM-CSF and thalidomide	thalidomide	-

Primary Outcome Measures

Name	Time	Method
Response Rate	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	To define the response rate in metastatic renal cell carcinoma patients receiving Peg-Intron, GM-CSF and thalidomide

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival	From registration until diease progression or death, whichever comes first.
Duration of Response	time from registration to the time of progressive disease among patients who achieve at least a partial response to treatment.
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

Trial Locations

Locations (1)

Hollings Cancer Center at Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States