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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00027664
First received: December 7, 2001
Last updated: August 6, 2013
Last verified: March 2002
  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
Biological: recombinant interferon alfa
Drug: thalidomide
Phase 2

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom, G12 0YN
Sponsors and Collaborators
Cancer Research UK
Investigators
Study Chair: Adrian L. Harris, MD Oxford University Hospitals NHS Trust
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00027664     History of Changes
Other Study ID Numbers: ICRF-C00.204, CDR0000069055, EU-20129
Study First Received: December 7, 2001
Last Updated: August 6, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Kidney Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Interferon-alpha
Interferons
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014