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

Metastatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00462982
• Other study ID #: 07-009
• Secondary ID: P30CA008748MSKCC
• Status: Completed
• Phase: Phase 2
• First received: April 18, 2007
• Last updated: November 24, 2015
• Start date: March 2007
• Est. completion date: August 2008

Study information

• Verified date: November 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Melanoma
• Melanoma (Skin)
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Drug:
• sunitinib malate

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	up to a year	No