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ABT-510 in Treating Patients With Metastatic Melanoma

A Phase II Study of Anti-angiogenesis Therapy for Metastatic Melanoma Using ABT-510

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00602199
Enrollment
42
Registered
2008-01-28
Start date
2004-11-30
Completion date
2005-06-30
Last updated
2011-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma (Skin)

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

OTHERimmunoenzyme technique
OTHERimmunohistochemistry staining method
OTHERlaboratory biomarker analysis
OTHERpharmacological study
PROCEDUREbiopsy

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Mayo Clinic
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frame
18-week progression-free survival rate

Secondary

MeasureTime 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026