Kidney CancerPhase 3NCT00005966
Interferon Alfa-2b With or Without Thalidomide in Treating Patients With Metastatic or Unresectable Kidney Cancer
A Phase 3 study testing recombinant interferon alfa and thalidomide in people with Kidney Cancer, run by Eastern Cooperative Oncology Group at 14 sites in 4 countries.
Trial summary
RATIONALE: Interferon alfa-2b may interfere with the growth of the cancer cells. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if interferon alfa-2b is more effective with or without thalidomide in treating 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
- Not given
- Where
- 14 sitesin 4 countries
- Study dates
- Oct 2000to Mar 2006
- Phase
- Phase 3
- 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 proven previously untreated metastatic or unresectable renal cell carcinoma
- Retroperitoneal lymph nodes that are unresectable or those that are not resected at the investigator's discretion are considered metastatic disease
- Prior nephrectomy allowed provided there is evidence of unresponsive metastatic disease after surgery or within one month prior to study enrollment
- Bidimensionally measurable disease
- Measurable disease must be outside any prior radiotherapy port
- No history of brain metastases unless surgically resected or treated with gamma knife radiotherapy and currently without radiologic evidence of CNS disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Hemoglobin at least 9 g/dL (transfusion allowed)
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 3 times upper limit of normal
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No myocardial infarction within the past 6 months
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 effective methods of contraception (1 highly active method and 1 barrier method) for at least 4 weeks before, during, and for at least 4 weeks after study participation
- No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No uncontrolled diabetes or any other concurrent illnesses that would increase risk
- No history of peripheral neuropathy
- No severe depression
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy (including adjuvant interferon alfa therapy), cellular therapy, or vaccine therapy for renal cell carcinoma
- No prior antiangiogenesis therapy for renal cell carcinoma
- Immunotherapy for prior malignancy allowed (except for interferon alfa therapy)
Chemotherapy:
- No prior chemotherapy for renal cell carcinoma
- Chemotherapy for prior malignancy allowed
Endocrine therapy:
- No prior hormonal therapy for renal cell carcinoma
Radiotherapy:
- See Disease Characteristics
- At least 2 weeks since prior radiotherapy and recovered
Surgery:
- See Disease Characteristics
Other:
- More than 7 days since prior IV antibiotics for infection
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
United States11 sites
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Mercy Cancer Center at Mercy Medical Center-Des Moines
Des Moines, Iowa, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, 50316-2301
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54307-3453
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, 68128-4157
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
Comprehensive Cancer Center at Our Lady of Mercy Medical Center
The Bronx, New York, 10466
About this study
Official title: Phase III Randomized Trial of Interferon-Alfa2b Alone Versus Interferon-Alfa2b Plus Thalidomide in Patients With Previously Untreated Metastatic or Unresectable Renal Cell Carcinoma
RATIONALE: Interferon alfa-2b may interfere with the growth of the cancer cells. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if interferon alfa-2b is more effective with or without thalidomide in treating kidney cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa-2b with or without thalidomide in treating patients who have previously untreated metastatic or unresectable kidney cancer.
Read the detailed description
OBJECTIVES:
- Compare the overall and progression-free survival at 24 weeks in patients with previously untreated metastatic or unresectable renal cell carcinoma treated with interferon alfa-2b with or without thalidomide.
- Compare the safety of these 2 regimens in these patients.
- Compare the quality of life of patients treated with these 2 regimens.
- Compare the pharmacodynamic effects of these regimens on pharmacodynamic measurements of angiogenesis such as serum and plasma angiogenic factor levels in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior nephrectomy (yes vs no), disease-free interval (no more than 1 year vs more than 1 year), and ECOG performance status (0 vs 1 or 2). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive interferon alfa-2b subcutaneously (SC) twice daily beginning on day 1.
- Arm II: Patients receive interferon alfa-2b as in arm I and oral thalidomide once daily beginning on day 1.
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) continue treatment for 24 weeks past CR.
Quality of life is assessed prior to randomization and then every 4 weeks through week 24.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 346 patients (173 per arm) will be accrued for this study within 2 years.
- Conditions
- Kidney Cancer
- Being tested
- recombinant interferon alfa, thalidomide
- Keywords
- stage III renal cell cancer, 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
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 startOct 2000
- Primary completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Michael S. Gordon, MD, Study chair, Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005966
- Sponsor's protocol ID
- CDR0000067949
- Other IDs
- ECOG-2898
- Status last verified
- Sep 2002
- First submitted
- 5 Jul 2000
- Last updated
- 5 Feb 2009
- Results posted
- No
Publications
Gordon MS, Manola J, Fairclough D, et al.: Low dose interferon-α2b (IFN) + thalidomide (T) in patients (pts) with previously untreated renal cell cancer (RCC). Improvement in progression-free survival (PFS) but not quality of life (QoL) or overall survival (OS). A phase III study of the Eastern Cooperative Oncology Group (E2898). [Abstract] J Clin Oncol 22 (Suppl 14): A-4516, 386s, 2004.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Trial of Interferon-Alfa2b Alone Versus Interferon-Alfa2b Plus Thalidomide in Patients With Previously Untreated Metastatic or Unresectable Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00005966
- Acronym / sponsor ID
- CDR0000067949
- Conditions
- Kidney Cancer
- Keywords
- stage III renal cell cancer, stage IV renal cell cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2000
- Primary completion
- Mar 2006 (actual)
- 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-2b may interfere with the growth of the cancer cells. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if interferon alfa-2b is more effective with or without thalidomide in treating kidney cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa-2b with or without thalidomide in treating patients who have previously untreated metastatic or unresectable kidney cancer.
Detailed description
OBJECTIVES:
- Compare the overall and progression-free survival at 24 weeks in patients with previously untreated metastatic or unresectable renal cell carcinoma treated with interferon alfa-2b with or without thalidomide.
- Compare the safety of these 2 regimens in these patients.
- Compare the quality of life of patients treated with these 2 regimens.
- Compare the pharmacodynamic effects of these regimens on pharmacodynamic measurements of angiogenesis such as serum and plasma angiogenic factor levels in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior nephrectomy (yes vs no), disease-free interval (no more than 1 year vs more than 1 year), and ECOG performance status (0 vs 1 or 2). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive interferon alfa-2b subcutaneously (SC) twice daily beginning on day 1.
- Arm II: Patients receive interferon alfa-2b as in arm I and oral thalidomide once daily beginning on day 1.
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) continue treatment for 24 weeks past CR.
Quality of life is assessed prior to randomization and then every 4 weeks through week 24.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 346 patients (173 per arm) will be accrued for this study within 2 years.
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2009.
- Results publicationGordon MS, Manola J, Fairclough D, et al.: Low dose interferon-α2b (IFN) + thalidomide (T) in patients (pts) with previously untreated renal cell cancer (RCC). Improvement in progression-free survival (PFS) but not quality of life (QoL) or overall survival (OS). A phase III study of the Eastern Cooperative Oncology Group (E2898). [Abstract] J Clin Oncol 22 (Suppl 14): A-4516, 386s, 2004.
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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.
Michael S. Gordon, MD study chair
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing recombinant interferon alfa and thalidomide in people with Kidney Cancer, run by Eastern Cooperative Oncology Group at 14 sites in 4 countries.
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: finished, as of the sponsor's last update on 5 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Australia, Peru, Puerto Rico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005966, which also lists 1 linked publication.
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 5 Feb 2009.