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

NCT ID: NCT00462982

Last Updated: 2015-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2008-08-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sunitinib

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

Group Type: EXPERIMENTAL

sunitinib malate

Intervention Type: DRUG

Interventions

sunitinib malate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lauren E. Abrey, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Paul B. Chapman, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Robert J. Motzer, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

P30CA008748

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MSKCC-07009

Identifier Type: -

Identifier Source: secondary_id

07-009

Identifier Type: -

Identifier Source: org_study_id