ABT-510 in Treating Patients With Metastatic Melanoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00602199
First received: January 11, 2008
Last updated: May 13, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin)
Drug: ABT-510
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: pharmacological study
Procedure: biopsy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Anti-angiogenesis Therapy for Metastatic Melanoma Using ABT-510

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 18-week progression-free survival rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate as defined by RECIST criteria [ Designated as safety issue: No ]
  • Overall survival time [ Designated as safety issue: No ]
  • Frequency of NK-cells, T-cells, and B-cells before the start of the first 5 courses of treatment [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: November 2004
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602199

Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Svetomir Markovic, MD, PhD Mayo Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Svetomir Nenad Markovic, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00602199     History of Changes
Other Study ID Numbers: CDR0000582475, P30CA015083, MC0375, 1439-04
Study First Received: January 11, 2008
Last Updated: May 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
stage IV melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on April 20, 2014