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

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), March 2002

Sponsored by: Cancer Research UK
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00027664
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Drug: recombinant interferon alfa
Drug: thalidomide
Phase II

MedlinePlus related topics:   Cancer    Kidney Cancer   

Drug Information available for:   Thalidomide    Interferon alfa-n1    Interferon alfa-2a    Interferon alfa-2b    Interferons   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Active Control
Official Title:   Interferon Alpha In Combination With Thalidomide In The Treatment Of Metastatic Renal Cell Carcinoma A Randomized Phase II Study

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Response rate [ Designated as safety issue: No ]
  • Anti-angiogenic effect [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]

Estimated Enrollment:   90
Study Start Date:   February 2001

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027664

Locations
United Kingdom, England
Leeds Cancer Centre at St. James's University Hospital     Recruiting
      Leeds, England, United Kingdom, LS9 7TF
      Contact: Peter J. Selby, MD, MA, FRCP     113-242-9883        
Oxford Radcliffe Hospital     Recruiting
      Oxford, England, United Kingdom, 0X3 9DU
      Contact: Adrian L. Harris, MD     44-1865-226-184        
United Kingdom, Scotland
Beatson West of Scotland Cancer Centre     Recruiting
      Glasgow, Scotland, United Kingdom, G12 0YN
      Contact: Paul A. Vasey, MD     44-141-3304-4006     pav1y@clinmed.gla.ac.uk    

Sponsors and Collaborators
Cancer Research UK

Investigators
Study Chair:     Adrian L. Harris, MD     Oxford Radcliffe Hospital    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000069055, ICRF-C00.204, EU-20129
First Received:   December 7, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00027664
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer  

Study placed in the following topic categories:
Interferon-alpha
Interferon Type I, Recombinant
Thalidomide
Interferons
Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Carcinoma
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Interferon Alfa-2a
Adenocarcinoma
Interferon Alfa-2b
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Immunosuppressive Agents
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Anti-Bacterial Agents
Neoplasms
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors
Leprostatic Agents

ClinicalTrials.gov processed this record on December 03, 2008




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