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

NCT00462982 | Completed Phase 2 Results

• 3 other identifiers: 07-009P30CA008748MSKCC-07009
• Study Type: interventional
• Target: 8
• 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 brain metastases caused by kidney cancer or melanoma.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Sunitinib

EXPERIMENTAL

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

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 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)

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

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

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; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Robert Motzer
• Organization: Memorial Sloan Kettering Cancer Center

motzerr@mskcc.org

646-422-4312

Study Officials

• Lauren E. Abrey, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Paul B. Chapman, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Robert J. Motzer, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: April 18, 2007
• First Posted: April 19, 2007
• Study Start: March 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 30, 2015
• Results First Posted: December 30, 2015

Record last verified: 2015-11

Locations

US (1)