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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014