ABT-510 in Treating Patients With Metastatic Melanoma

Melanoma (Skin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00602199
• Other study ID #: CDR0000582475
• Secondary ID: P30CA015083MC037
• Status: Completed
• Phase: Phase 2
• First received: January 11, 2008
• Last updated: May 13, 2011
• Start date: November 2004
• Est. completion date: June 2005

Study information

• Verified date: May 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Drug:
• ABT-510

Other:
• immunoenzyme technique

• immunohistochemistry staining method

• laboratory biomarker analysis

• pharmacological study

Procedure:
• biopsy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

References & Publications (1)

Markovic SN, Suman VJ, Rao RA, Ingle JN, Kaur JS, Erickson LA, Pitot HC, Croghan GA, McWilliams RR, Merchan J, Kottschade LA, Nevala WK, Uhl CB, Allred J, Creagan ET. A phase II study of ABT-510 (thrombospondin-1 analog) for the treatment of metastatic me — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	18-week progression-free survival rate			No
Secondary	Objective response rate as defined by RECIST criteria			No
Secondary	Overall survival time			No
Secondary	Frequency of NK-cells, T-cells, and B-cells before the start of the first 5 courses of treatment			No