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

NCT00027664 | Unknown Phase 2

• 3 other identifiers: ICRF-C00.204CDR0000069055EU-20129
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

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.

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancer

Outcome Measures

Primary Outcomes (5)

• Safety

• Toxicity

• Response rate

• Anti-angiogenic effect

• Quality of life

Interventions

recombinant interferon alfa BIOLOGICAL

thalidomide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Research UK: lead

Study Sites (3)

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G12 0YN, United Kingdom

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Interferon-alpha; Thalidomide

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Adrian L. Harris, MD

  Oxford University Hospitals NHS Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 7, 2001
• First Posted: January 27, 2003
• Study Start: February 1, 2001
• Last Updated: August 7, 2013

Record last verified: 2002-03

Locations

GB (3)