Melanoma (Skin)
Conditions
Keywords
stage IV melanoma
Brief 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.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 18-week progression-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate as defined by RECIST criteria | — |
| Overall survival time | — |
| Frequency of NK-cells, T-cells, and B-cells before the start of the first 5 courses of treatment | — |