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Interferon Alfa With or Without Thalidomide in Treating Patients With Metastatic Kidney Cancer

Primary Purpose

Kidney Cancer

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
recombinant interferon alfa
thalidomide
Sponsored by
Cancer Research UK
About
Eligibility
Locations
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed metastatic renal cell carcinoma Measurable progressive disease, defined as non-irradiated marker lesions greater than 1 cm PATIENT CHARACTERISTICS: Age: Over 18 Performance status: WHO 0-2 Life expectancy: More than 12 weeks Hematopoietic: Neutrophil count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin greater than 10 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST/ALT less than 5 times ULN Renal: Creatinine clearance greater than 50 mL/min OR Edetic acid clearance greater than 40 mL/min Cardiovascular: No unstable angina or myocardial infarction within the past 6 months Other: No other prior invasive malignancy except cervical intraepithelial neoplasia or nonmelanomatous skin cancer No chronic neurological disease causing peripheral neuropathy No diabetes mellitus Not pregnant or nursing Negative pregnancy test Fertile patients must use at least one highly effective method and at least one additional effective method of contraception for female patients and barrier contraception for male patients for at least 2 weeks before and during study PRIOR CONCURRENT THERAPY: Biologic therapy: No prior interferon alfa for metastatic renal cell carcinoma Chemotherapy: No prior systemic chemotherapy for metastatic renal cell carcinoma No concurrent cytotoxic therapy Endocrine therapy: No concurrent corticosteroids Radiotherapy: See Disease Characteristics Concurrent local radiotherapy for symptomatic secondary sites of disease allowed if these sites are not being used as markers of disease response Surgery: Not specified Other: No other prior systemic treatment for metastatic renal cell carcinoma No concurrent chronic medication known to cause peripheral neuropathy

Sites / Locations

  • Leeds Cancer Centre at St. James's University Hospital
  • Oxford Radcliffe Hospital
  • Beatson West of Scotland Cancer Centre

Outcomes

Primary Outcome Measures

Safety
Toxicity
Response rate
Anti-angiogenic effect
Quality of life

Secondary Outcome Measures

Full Information

First Posted
December 7, 2001
Last Updated
August 6, 2013
Sponsor
Cancer Research UK
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1. Study Identification

Unique Protocol Identification Number
NCT00027664
Brief Title
Interferon Alfa With or Without Thalidomide in Treating Patients With Metastatic Kidney Cancer
Official Title
Interferon Alpha In Combination With Thalidomide In The Treatment Of Metastatic Renal Cell Carcinoma A Randomized Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2002
Overall Recruitment Status
Unknown status
Study Start Date
February 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Cancer Research UK

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if interferon alfa is more effective with or without thalidomide in treating metastatic kidney cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of interferon alfa with or without thalidomide in treating patients who have metastatic kidney cancer.
Detailed Description
OBJECTIVES: Determine the safety of interferon alfa and thalidomide in patients with metastatic renal cell carcinoma. Compare the relative toxicity of interferon alfa with or without thalidomide in these patients. Assess the antiangiogenic effect of thalidomide by monitoring the angiogenesis-associated factors in these patients. Compare, in a preliminary manner, the efficacy of interferon alfa with or without thalidomide in these patients. Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive interferon alfa subcutaneously 3 times a week and oral thalidomide once daily for 12 weeks. Arm II: Patients receive interferon alfa only as in arm I. Treatment in both arms repeats every 12 weeks in the absence of disease progression or unacceptable toxicity. Patients in arm II who develop disease progression discontinue interferon alfa and receive thalidomide only as in arm I. Quality of life is assessed at baseline and then every 3 weeks during each study course. PROJECTED ACCRUAL: A total of 90 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
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa
Intervention Type
Drug
Intervention Name(s)
thalidomide
Primary Outcome Measure Information:
Title
Safety
Title
Toxicity
Title
Response rate
Title
Anti-angiogenic effect
Title
Quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic renal cell carcinoma Measurable progressive disease, defined as non-irradiated marker lesions greater than 1 cm PATIENT CHARACTERISTICS: Age: Over 18 Performance status: WHO 0-2 Life expectancy: More than 12 weeks Hematopoietic: Neutrophil count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin greater than 10 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST/ALT less than 5 times ULN Renal: Creatinine clearance greater than 50 mL/min OR Edetic acid clearance greater than 40 mL/min Cardiovascular: No unstable angina or myocardial infarction within the past 6 months Other: No other prior invasive malignancy except cervical intraepithelial neoplasia or nonmelanomatous skin cancer No chronic neurological disease causing peripheral neuropathy No diabetes mellitus Not pregnant or nursing Negative pregnancy test Fertile patients must use at least one highly effective method and at least one additional effective method of contraception for female patients and barrier contraception for male patients for at least 2 weeks before and during study PRIOR CONCURRENT THERAPY: Biologic therapy: No prior interferon alfa for metastatic renal cell carcinoma Chemotherapy: No prior systemic chemotherapy for metastatic renal cell carcinoma No concurrent cytotoxic therapy Endocrine therapy: No concurrent corticosteroids Radiotherapy: See Disease Characteristics Concurrent local radiotherapy for symptomatic secondary sites of disease allowed if these sites are not being used as markers of disease response Surgery: Not specified Other: No other prior systemic treatment for metastatic renal cell carcinoma No concurrent chronic medication known to cause peripheral neuropathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian L. Harris, MD
Organizational Affiliation
Oxford University Hospitals NHS Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Oxford Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
0X3 9DU
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0YN
Country
United Kingdom

12. IPD Sharing Statement

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Interferon Alfa With or Without Thalidomide in Treating Patients With Metastatic Kidney Cancer

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