Patient case: 73-year-old male with melanoma; genetic feature: tumor cells negative for PD-L1 expression

Clinical trial: ABT-510 in Treating Patients With Metastatic Melanoma

Summary: RATIONALE: ABT-510 may stop the growth of melanoma by blocking blood flow to the tumor.
  PURPOSE: This phase II trial is studying how well giving ABT-510 works in treating patients with metastatic melanoma.

Detailed description: OBJECTIVES:
  -  Examine the safety profile of ABT-510 in patients with metastatic malignant melanoma.
  -  Examine the antitumor activity (i.e., time to progression and response rates) in patients treated with ABT-510.
  -  Determine the pharmacodynamic effects of ABT-510 and its potential impact on immune cell function in these patients.
  OUTLINE: Patients receive ABT-510 subcutaneously twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
  Blood samples are obtained at baseline, before treatment on day 1 of cycles 2 and 3, and then every other course thereafter for pharmacological and ancillary studies. Samples are evaluated for EC enumeration, expression profiling, circulating tumor cell quantification, analysis of T-cell functions (i.e., immunophenotyping for NK-, T- and B-cell phenotypes as well as ELISPOT analysis against common environmental pathogens and T cell spectratyping), and angiogenesis bioassays. Patients also undergo ultrasound-guided core tumor biopsies for histological analysis of microvascular density (CD38 and von Willebrand Factor immunohistochemistry) at baseline and before treatment on day 1 of courses 3 and 5.
  After completion of study treatment, patients are followed every 3 months for up to 5 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed malignant melanoma
  -  Stage IV disease
  -  No known potentially curative standard therapy that exists or is proven capable of extending life expectancy
  -  Measurable disease
  -  No history of or current CNS metastases
  -  MRI of the brain to confirm absence of CNS metastases within the past 28 days is required
  -  No known, presently active carcinomatous meningitis
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-2
  -  Life expectancy ≥ 6 months
  -  ANC ≥ 1,500/mm³
  -  Platelet count ≥ 100,000/mm³
  -  Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)
  -  AST ≤ 3 times ULN
  -  Creatinine ≤ 2.5 times ULN
  -  Hemoglobin ≥ 9.0 g/dL
  -  Prothrombin time normal
  -  Willing to return to Mayo Clinic Rochester, Jacksonville or Scottsdale for follow-up
  -  Must be able to self-administer or has a caregiver who can reliably administer subcutaneous injections
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  No uncontrolled or current infection
  -  No New York Heart Association class III-IV heart disease
  -  No recent history of (i.e., ≤ 12 weeks from study day 1) or current cancer-related bleeding event (e.g., hemoptysis)
  -  No recent history of (within the past 4 weeks) or current noncancer-related clinically significant bleeding event
  -  No uncontrolled hypertension
  -  No history of stroke or other CNS bleeding events (e.g., aneurysms)
  PRIOR CONCURRENT THERAPY:
  -  At least 4 weeks since prior chemotherapy and recovered (6 weeks for mitomycin C or nitrosoureas)
  -  At least 4 weeks since prior immunotherapy, biologic therapy, radiotherapy, or surgery
  -  No concurrent anticoagulation therapy or antiplatelet therapy
  -  No other concurrent antineoplastic agents (e.g., cytotoxic chemotherapy, immunotherapy, radiotherapy, or investigational therapy) except local radiotherapy for supportive reasons involving a small radiation field

Relevance to patient case: not relevant