Drug that starves tumors shows promise against advanced kidney cancer
NCT ID NCT00403169
First seen Jul 02, 2026 · Last updated Jul 02, 2026
Summary
This phase II trial tests the drug lenalidomide (CC-5013) in people with advanced or inoperable kidney cancer. Lenalidomide works by cutting off blood flow to tumors, which may stop or slow their growth. The study aims to see how many patients respond to treatment and what side effects occur.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lenalidomide (also called CC-5013)
- What this could lead to
- If it works, lenalidomide could offer a new treatment option for people with advanced kidney cancer that cannot be removed by surgery.
- What could go wrong
- This is a small, early-phase trial with only 28 participants, so results may not apply to everyone. Lenalidomide can cause serious side effects, and the cancer may still grow.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
28 people
The number who actually took part.
- Start date
-
Aug 2004
- Finished
-
May 2009
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 120 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed renal cell carcinoma (RCC) * Advanced or unresectable RCC * Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques OR ≥ 10 mm with spiral CT scan * No brain metastases * Brain metastases that have been treated with either radiotherapy or surgery and remain asymptomatic, with no active brain metastases, as shown by CT scan or MRI, for ≥ 6 months are allowed PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100% * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine ≤ 2.0 mg/dL * Bilirubin ≤ 1.5 mg/dL * AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancies within the past 5 years, except for treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, localized prostate cancer, or superficial bladder cancer * No history of allergic reactions attributed to compounds of similar chemical or biological composition to lenalidomide or thalidomide * No uncontrolled intercurrent illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness or social situation that would limit study compliance * No hepatitis A, B, or C positivity * No HIV positivity PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No more than 1 prior systemic therapy for RCC (e.g., chemotherapy, hormonal therapy, immunotherapy) * At least 4 weeks since prior surgery, radiotherapy, hormonal therapy, chemotherapy, or immunotherapy and recovered * No prior lenalidomide * No other concurrent anticancer agents or treatments * No other concurrent investigational agents * No concurrent sargramostim (GM-CSF), radiotherapy, or thalidomide
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065, United States
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