Patient case: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

Clinical trial: Vatalanib in Treating Patients With Metastatic Cutaneous Melanoma That Cannot be Removed by Surgery

Summary: RATIONALE: Vatalanib 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 vatalanib works in treating patients with metastatic cutaneous melanoma that cannot be removed by surgery.

Detailed description: OBJECTIVES:
  Primary
  -  To determine the response rate in patients with unresectable metastatic cutaneous melanoma treated with vatalanib.
  Secondary
  -  To determine the time to progression in these patients.
  -  To determine the 6-month and 1-year survival of these patients.
  -  To determine the overall survival of these patients.
  -  To determine the safety and toxicity of this drug in these patients.
  OUTLINE: This is a multicenter study.
  Patients receive oral vatalanib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  After completion of study therapy, patients are followed at 8 weeks and then periodically thereafter.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed metastatic cutaneous melanoma
  -  Unresectable disease
  -  Measurable disease, defined as ≥ 1 bidimensionally measurable lesion by clinical or radiological techniques (i.e., chest x-ray, CT scan, or conventional MRI scan) using RECIST criteria
  -  No history or presence of CNS disease (i.e., primary brain tumor, malignant seizures, clinically symptomatic CNS metastases, or carcinomatous meningitis)
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-2
  -  Life expectancy ≥ 12 weeks
  -  Hemoglobin ≥ 10 g/dL
  -  Platelet count ≥ 100,000/mm^3
  -  WBC ≥ 3,000/mm^3
  -  ANC ≥ 1,500/mm^3
  -  Bilirubin ≤ 1.5 x upper limit of normal (ULN)
  -  Alkaline phosphatase ≤ 3 x ULN (≤ 5 if liver metastases are present)
  -  Transaminases ≤ 3 x ULN (≤ 5 if liver metastases are present)
  -  Creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min
  -  Total urinary protein ≤ 500 mg by 24-hour urine collection
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective barrier contraception
  -  No history of other malignant disease except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
  -  No other serious or uncontrolled illness which, in the opinion of the investigator, precludes study entry
  -  No medical or psychiatric condition that precludes giving informed consent
  -  No history of renal disease (e.g., glomerulonephritis) or renal vascular disease
  -  No acute or chronic active liver disease (e.g., hepatitis or cirrhosis)
  -  No concurrent severe and/or uncontrolled medical conditions that would compromise participation in the study, including any of the following:
  -  Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen
  -  Unstable angina pectoris
  -  Symptomatic congestive heart failure
  -  Myocardial infarction within the past 6 months
  -  Serious uncontrolled cardiac arrhythmia
  -  Uncontrolled diabetes
  -  Active or uncontrolled infection
  -  No impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of vatalanib including, but not limited to, any of the following conditions:
  -  Ulcerative disease
  -  Uncontrolled nausea
  -  Vomiting
  -  Diarrhea which might result in malabsorption
  -  Any known malabsorption syndrome
  -  Bowel obstruction
  -  Inability to swallow the capsules/tablets
  PRIOR CONCURRENT THERAPY:
  -  Recovered from all prior therapy
  -  Prior adjuvant therapy allowed
  -  Prior radiotherapy allowed
  -  Measurable target lesions must not have been irradiated
  -  No more than one line of prior systemic therapy for advanced melanoma
  -  More than 4 weeks since prior chemotherapy, immunotherapy, or investigational agent
  -  More than 2 weeks since prior surgery
  -  No concurrent warfarin or other similar oral anticoagulants that are metabolized by the cytochrome p450 system
  -  Concurrent heparin allowed
  -  Concurrent radiotherapy for symptomatic disease is allowed, provided the lesions being irradiated contribute ≤ 20% of the sum of the longest diameter for all target lesions being used to determine response

Relevance to patient case: not relevant