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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Completed

Phase 2

Conditions

Metastatic Cancer

Melanoma (Skin)

Kidney Cancer

Treatments

Drug: sunitinib malate

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00462982

P30CA008748 (U.S. NIH Grant/Contract)

07-009

MSKCC-07009

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)