ABT-510 in Treating Patients With Metastatic Melanoma

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)

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