Drug shows promise for kidney cancer brain metastases in early trial
NCT ID NCT00814021
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tested the drug sunitinib in 21 patients with kidney cancer that had spread to the brain. The goal was to see if the drug could shrink brain tumors by blocking blood flow and cell growth. Researchers measured how many patients had a response after two treatment cycles.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sunitinib (a drug that blocks tumor growth and blood flow)
- What this could lead to
- If it works, this could offer a new treatment option for kidney cancer that has spread to the brain, potentially shrinking tumors and controlling the disease.
- What could go wrong
- This is a small, early-phase trial with only 21 participants, so results may not apply widely. The drug may not shrink brain tumors effectively or could cause side effects.
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
-
21 people
The number who actually took part.
- Start date
-
Apr 2009
- Finished
-
Mar 2011
- 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 adenocarcinoma of the kidney * Metastatic disease * Measurable disease by RECIST criteria * Presence of previously untreated or recurrent brain metastases following radiotherapy or surgery * No brain metastasis revealed by hemorrhage * No single brain metastasis \< 2 cm that is accessible by surgery or radiosurgery PATIENT CHARACTERISTICS: * WHO performance status 0-2 (unless paresis due to brain metastases) * ANC \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 8 g/dL * PT or INR \< 1.5 times upper limit of normal (ULN) * AST/ALT \< 2.5 times ULN (\< 5 times ULN in the case of liver metastases) * Total bilirubin \< 1.5 times ULN * Serum creatinine \< 200 μmol/L * Not pregnant or nursing * Fertile patients must use effective contraception during and for up to 30 days following completion of study treatment * No other cancer except for in situ cervical cancer, curatively treated basal cell carcinoma of the skin, or other curatively treated cancer without evidence of recurrence within the past 5 years * No uncontrolled hypertension (systolic BP ≥ 160 mm Hg and/or diastolic BP ≥ 90 mm Hg) * None of the following cardiac conditions within the past 6 months: * Significant cardiovascular disease * NYHA class III-IV congestive heart failure * Myocardial infarction * Unstable angina * Severe arrhythmia * Cerebrovascular accident * Severe thromboembolism * No serious neuropsychiatric disease * No psychological, familial, social, or geographic situations that preclude clinical follow-up * No patient deprived of liberty by a court or administrative order * Able to understand French PRIOR CONCURRENT THERAPY: * At least 6 months since prior antineoplastic treatment with sunitinib malate * At least 4 weeks since other prior treatment * At least 3 weeks since prior hematopoietic growth factors (i.e., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) * No concurrent antivitamin K at curative or anticoagulation doses
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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
-
Institut Claudius Regaud
Toulouse, 31052, France
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