Clinical trial NCT00462982: Sunitinib in Treating Patients With Brain Metastases Caused by Kidney Cancer or Melanoma
Official title: A Phase II Study of SU11248 (Sunitinib) in Patients With Renal Cell Carcinoma and Melanoma Metastatic to the Brain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-04-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Central Nervous System (CNS) Response Rate by RECIST Criteria
timeFrame: up to a year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Lauren E. Abrey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Sloan Kettering Cancer Center
name: Paul B. Chapman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Sloan Kettering Cancer Center
name: Robert J. Motzer, MD
role: PRINCIPAL_INVESTIGATOR
References: