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

Phase 2
18 Years
Not Enrolling
Melanoma (Skin)

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Trial Information

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


- 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.

Inclusion Criteria


- 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

- No known, presently active carcinomatous meningitis


- 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)


- At least 4 weeks since prior chemotherapy and recovered (6 weeks for mitomycin C or

- At least 4 weeks since prior immunotherapy, biologic therapy, radiotherapy, or

- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

18-week progression-free survival rate

Safety Issue:


Principal Investigator

Svetomir Markovic, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

November 2004

Completion Date:

June 2005

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • Melanoma