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Sunitinib in Treating Patients With Brain Metastases Caused by Kidney Cancer or Melanoma

A Phase II Study of SU11248 (Sunitinib) in Patients With Renal Cell Carcinoma and Melanoma Metastatic to the Brain

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00462982
Enrollment
8
Registered
2007-04-19
Start date
2007-03-31
Completion date
2008-08-31
Last updated
2015-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer, Melanoma (Skin), Metastatic Cancer

Keywords

stage IV melanoma, tumors metastatic to brain, stage IV renal cell cancer, recurrent melanoma, recurrent renal cell cancer

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 brain metastases caused by kidney cancer or melanoma.

Detailed description

OBJECTIVES: Primary * Determine the efficacy of sunitinib malate, in terms of objective radiographic response of brain lesions, in patients with brain metastases secondary to renal cell carcinoma or melanoma. Secondary * Determine overall and progression-free survival. OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed periodically.

Interventions

DRUGsunitinib malate

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed melanoma or renal cell carcinoma * Metastatic brain disease * Must have assessable target intracranial lesion(s), defined as measurable disease ≥ 10 mm in longest diameter that is not appropriate for stereotactic radiosurgery or surgical resection * Lesions previously treated with radiosurgery AND not eligible for resection can only be used as target lesions if there has been true tumor progression on baseline scan (i.e., ≥ 20% increase in longest diameter of lesion) rather than radionecrosis * True progression must be confirmed by PET scan or other corroborating imaging used to distinguish radionecrosis * No leptomeningeal metastases or primary dural metastases PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-1 OR Karnofsky PS 60-100% * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Total leukocyte count ≥ 3,000/mm³ * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine ≤ 2.0 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * Hemoglobin ≥ 9.0 g/dL * Calcium ≤ 12.0 mg/dL * AST and ALT ≤ 1.5 times ULN * PT ≤ 1.5 times ULN * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No uncontrolled medical illness including, but not limited to, any of the following: * Hypertension (i.e., blood pressure \> 150/100 mm Hg) * Thyroid disease * Severe valvular disease * Severe pulmonary disease * HIV/AIDS * Severe psychiatric illness * No cardiac dysrhythmia ≥ grade 2 * No prolonged QTc interval on baseline EKG * No systemic hemorrhage ≥ grade 2 within the past 4 weeks * No CNS hemorrhage ≥ grade 2 * Grade 1 (asymptomatic) CNS hemorrhage allowed at investigator's discretion * None of the following within the past 6 months: * Myocardial infarction * Unstable angina * Symptomatic congestive heart failure * Stroke/transient ischemic attack * Pulmonary embolism * Ejection fraction ≥ 50% by baseline echocardiogram OR \< 20% decrease in ejection fraction from a prior study PRIOR CONCURRENT THERAPY: * No prior multi-targeted tyrosine kinase inhibitor therapy (e.g., sunitinib malate or sorafenib) * No coronary/peripheral arterial bypass surgery within the past 6 months * More than 4 weeks since prior surgery and recovered * More than 4 weeks since prior and no other concurrent experimental therapy or cytotoxic chemotherapy * More than 4 weeks since prior immunotherapy * More than 2 weeks since prior stereotactic radiosurgery and recovered * More than 7 days since prior and no concurrent drugs that interact with CYP3A4 family, including enzyme-inducing antiepileptic drugs, warfarin, or Hypericum perforatum extract (St. John's wort)

Design outcomes

Primary

MeasureTime frameDescription
Central Nervous System (CNS) Response Rate by RECIST Criteriaup to a yearResponse and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques (CT, MRI, X-ray) or as \>10 mm with spiral CT scan. This study will use a minimum diameter of 10 mm for measurable lesions in the brain, regardless of imaging modality. All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters). All other lesions are considered non-measurable disease. Bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, inflammatory breast disease, and cystic lesions are all nonmeasurable.

Countries

United States

Participant flow

Participants by arm

ArmCount
Sunitinib
Patients will be treated with 50 mg daily for four out of every six weeks.
8
Total8

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event1
Overall StudyPatient Not Treated2

Baseline characteristics

CharacteristicSunitinib
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
2 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
Sex: Female, Male
Female
3 Participants
Sex: Female, Male
Male
5 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
6 / 8
serious
Total, serious adverse events
4 / 8

Outcome results

Primary

Central Nervous System (CNS) Response Rate by RECIST Criteria

Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques (CT, MRI, X-ray) or as \>10 mm with spiral CT scan. This study will use a minimum diameter of 10 mm for measurable lesions in the brain, regardless of imaging modality. All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters). All other lesions are considered non-measurable disease. Bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, inflammatory breast disease, and cystic lesions are all nonmeasurable.

Time frame: up to a year

ArmMeasureGroupValue (NUMBER)
SunitinibCentral Nervous System (CNS) Response Rate by RECIST CriteriaStable Disease (SD)3 participants
SunitinibCentral Nervous System (CNS) Response Rate by RECIST CriteriaProgression of Disease (POD)2 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026