Kidney CancerPhase 2NCT00096525
Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer
A Phase 2 study testing lenalidomide in people with Kidney Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Biological therapy such as lenalidomide use different ways to stimulate the immune system and stop tumor cells from growing. It may also stop the growth of tumor cells by stopping blood flow to the tumor. 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?
- lenalidomide
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Aug 2005
- 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 renal cell carcinoma (RCC)
- Advanced or unresectable disease
- At least 1 measurable lesion
- No active brain metastases
- Prior brain metastases allowed provided patient has been treated with radiotherapy or surgery AND remains asymptomatic for ≥ 6 months
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 mg/dL
- AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- No hepatitis A, B, or C infection
Renal
- Creatinine ≤ 2.0 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No known hypersensitivity to thalidomide
- No other serious medical condition, laboratory abnormality, or psychiatric illness that would preclude giving informed consent
- No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, localized prostate cancer, or superficial bladder cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No more than 1 prior systemic immunotherapy regimen for RCC
- No prior lenalidomide (CC-5013)
- No prior or concurrent thalidomide
Chemotherapy
- No more than 1 prior systemic chemotherapy regimen for RCC
Endocrine therapy
- No more than 1 prior systemic hormonal therapy regimen for RCC
Radiotherapy
- See Disease Characteristics
- No concurrent radiotherapy
Surgery
- See Disease Characteristics
- At least 4 weeks since prior surgery and recovered
Other
- No more than 1 other prior systemic therapy regimen for RCC
- No other concurrent anticancer therapies
- No other concurrent investigational agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Phase II Trial of CC-5013 in Patients With Advanced Renal Cell Carcinoma With Either No Prior Treatment or One Prior Treatment Regimen
RATIONALE: Biological therapy such as lenalidomide use different ways to stimulate the immune system and stop tumor cells from growing. It may also stop the growth of tumor cells by stopping blood flow to the tumor.
PURPOSE: This phase II trial is studying how well lenalidomide works in treating patients with advanced or unresectable kidney cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the best response in patients with advanced or unresectable renal cell cancer treated with lenalidomide (CC-5013).
- Determine the time to disease progression in patients treated with this drug.
Secondary
- Determine the safety of this drug in these patients.
OUTLINE: This is an open-label study.
Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 30 days and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.
- Conditions
- Kidney Cancer
- Being tested
- lenalidomide
- Keywords
- recurrent renal cell cancer, 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.
lenalidomideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy (complete and partial response)
Secondary outcomes (2)
Toxicity
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2004 (estimated)
- Study startJul 2004
- Primary completionAug 2005
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.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Gnanamba V. Kondagunta, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096525
- Sponsor's protocol ID
- 04-014
- Other IDs
- MSKCC-04014
- Status last verified
- Jan 2013
- First submitted
- 9 Nov 2004
- Last updated
- 17 Jan 2013
- Results posted
- No
Publications
Patel PH, Kondagunta GV, Schwartz L, Ishill N, Bacik J, DeLuca J, Russo P, Motzer RJ. Phase II trial of lenalidomide in patients with metastatic renal cell carcinoma. Invest New Drugs. 2008 Jun;26(3):273-6. doi: 10.1007/s10637-007-9107-y. Epub 2007 Dec 27.
PubMed 18161005
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of CC-5013 in Patients With Advanced Renal Cell Carcinoma With Either No Prior Treatment or One Prior Treatment Regimen
- ClinicalTrials.gov ID
- NCT00096525
- Acronym / sponsor ID
- 04-014
- Conditions
- Kidney Cancer
- Keywords
- recurrent renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2004
- Primary completion
- Aug 2005 (actual)
- First posted
- 10 Nov 2004 (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: Biological therapy such as lenalidomide use different ways to stimulate the immune system and stop tumor cells from growing. It may also stop the growth of tumor cells by stopping blood flow to the tumor.
PURPOSE: This phase II trial is studying how well lenalidomide works in treating patients with advanced or unresectable kidney cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the best response in patients with advanced or unresectable renal cell cancer treated with lenalidomide (CC-5013).
- Determine the time to disease progression in patients treated with this drug.
Secondary
- Determine the safety of this drug in these patients.
OUTLINE: This is an open-label study.
Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 30 days and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
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 |
|---|---|---|
| lenalidomide | Drug | – |
Primary outcome
Efficacy (complete and partial response)
2 secondary outcomes
Toxicity
Adverse events
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 17 Jan 2013.
- Results publication: PubMed 18161005Patel PH, Kondagunta GV, Schwartz L, Ishill N, Bacik J, DeLuca J, Russo P, Motzer RJ. Phase II trial of lenalidomide in patients with metastatic renal cell carcinoma. Invest New Drugs. 2008 Jun;26(3):273-6. doi: 10.1007/s10637-007-9107-y. Epub 2007 Dec 27.
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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.
Gnanamba V. Kondagunta, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lenalidomide in people with Kidney Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 17 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
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.
What does the primary outcome measure?
Efficacy (complete and partial response). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00096525, 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 17 Jan 2013.