Kidney CancerPhase 2NCT00027664
Interferon Alfa With or Without Thalidomide in Treating Patients With Metastatic Kidney Cancer
A Phase 2 study testing recombinant interferon alfa and thalidomide in people with Kidney Cancer, run by Cancer Research UK at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- recombinant interferon alfa and thalidomide
- How many people
- 90 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Feb 2001to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G12 0YN
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Oxford Radcliffe Hospital
Oxford, England, 0X3 9DU
About this study
Official title: Interferon Alpha In Combination With Thalidomide In The Treatment Of Metastatic Renal Cell Carcinoma A Randomized Phase II Study
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.
Read the 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.
- Conditions
- Kidney Cancer
- Being tested
- recombinant interferon alfa, thalidomide
- Keywords
- stage IV renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant interferon alfaBiological
thalidomideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Toxicity
Response rate
Anti-angiogenic effect
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startFeb 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Research UK
- Sponsor type
- University, hospital or other
- Investigators
- Adrian L. Harris, MD, Study chair, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00027664
- Sponsor's protocol ID
- ICRF-C00.204
- Other IDs
- CDR0000069055, EU-20129
- Status last verified
- Mar 2002
- First submitted
- 7 Dec 2001
- Last updated
- 7 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interferon Alpha In Combination With Thalidomide In The Treatment Of Metastatic Renal Cell Carcinoma A Randomized Phase II Study
- ClinicalTrials.gov ID
- NCT00027664
- Acronym / sponsor ID
- ICRF-C00.204
- Conditions
- Kidney Cancer
- Keywords
- stage IV renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cancer Research UKUniversity, hospital or other
- Study start
- Feb 2001
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant interferon alfa | Biological | – |
| thalidomide | Drug | – |
Primary outcome
Safety
Toxicity
Response rate
Anti-angiogenic effect
Quality of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian L. Harris, MD study chair
Oxford University Hospitals NHS Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing recombinant interferon alfa and thalidomide in people with Kidney Cancer, run by Cancer Research UK at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.