search
Back to results

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

Primary Purpose

Kidney Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PEG-interferon alfa-2b
GM-CSF
thalidomide
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hollings Cancer Center at Medical University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PEG-Intron, BM-CSF and thalidomide

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of Response
Frequency of Adverse Events Assessed by NCI CTC Version 2
Progression-free Survival

Full Information

First Posted
September 7, 2004
Last Updated
June 13, 2018
Sponsor
Medical University of South Carolina
search

1. Study Identification

Unique Protocol Identification Number
NCT00090870
Brief Title
PEG-Interferon Alfa-2b, Sargramostim, and Thalidomide in Treating Patients With Metastatic Kidney Cancer
Official Title
A Phase II Study Of Peg-Intron, GM-CSF And Thalidomide In Metastatic Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
Pharmaceutical collaborator pulled funding.
Study Start Date
April 2002 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
stage IV renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEG-Intron, BM-CSF and thalidomide
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
PEG-interferon alfa-2b
Intervention Description
Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.
Intervention Type
Biological
Intervention Name(s)
GM-CSF
Intervention Description
GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle
Intervention Type
Drug
Intervention Name(s)
thalidomide
Intervention Description
200mg daily by mouth
Primary Outcome Measure Information:
Title
Response Rate
Description
To define the response rate in metastatic renal cell carcinoma patients receiving Peg-Intron, GM-CSF and thalidomide
Time Frame
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 Outcome Measure Information:
Title
Duration of Response
Time Frame
time from registration to the time of progressive disease among patients who achieve at least a partial response to treatment.
Title
Frequency of Adverse Events Assessed by NCI CTC Version 2
Time Frame
From the first day of treatment until the end of treatment visit, an average of 6 months
Title
Progression-free Survival
Time Frame
From registration until diease progression or death, whichever comes first.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uzair B. Chaudhary, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gustavo Leone
Organizational Affiliation
Medical University of South Carolina, Hollings Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs