Sunitinib in Treating Patients With Kidney Cancer That Has Spread to the Brain

NCT00814021 | Completed Phase 2

• 6 other identifiers: 07URO02ICREGAUD-07URO02ICREGAUD-Metastases CerebralesINCA-RECF0821PFIZER-ICREGAUD-07URO02EUDRACT-2008-000948-13
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with kidney cancer that has spread to the brain.

Conditions

Kidney Cancer; Metastatic Cancer

Keywords

recurrent renal cell cancer; stage IV renal cell cancer; tumors metastatic to brain

Outcome Measures

Primary Outcomes (1)

• Objective response rate in the brain after 2 courses

  From beginning of treatment until 2 courses of treatment

Study Arms (1)

sunitinib,

EXPERIMENTAL

Drug: sunitinib malate

Interventions

sunitinib malate DRUG

sunitinib,

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (1)

Institut Claudius Regaud

Toulouse, 31052, France

Location

Related Publications (1)

• Chevreau C, Ravaud A, Escudier B, Amela E, Delva R, Rolland F, Tosi D, Oudard S, Blanc E, Ferlay C, Negrier S; French Group on Renal Cancer. A phase II trial of sunitinib in patients with renal cell cancer and untreated brain metastases. Clin Genitourin Cancer. 2014 Feb;12(1):50-4. doi: 10.1016/j.clgc.2013.09.008. Epub 2013 Sep 28.

  PMID: 24268852 RESULT

MeSH Terms

Conditions

Kidney Neoplasms; Neoplasm Metastasis; Carcinoma, Renal Cell; Brain Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Christine Chevreau-Dalbianco, MD

  Institut Claudius Regaud

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2008
• First Posted: December 23, 2008
• Study Start: April 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

FR (1)