ABI-007 in Treating Patients With Inoperable Locally Recurrent or Metastatic Melanoma
- Conditions
- Melanoma (Skin)
- Registration Number
- NCT00081042
- Lead Sponsor
- Jonsson Comprehensive Cancer Center
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well ABI-007 works in treating patients with inoperable (unresectable) locally recurrent or metastatic melanoma.
- Detailed Description
OBJECTIVES:
Primary
* Determine the antitumor activity of ABI-007 in patients with inoperable locally recurrent or metastatic melanoma.
* Determine the safety and tolerability of this drug in these patients.
Secondary
* Determine the time to disease progression, in terms of the rate and duration of response or stable disease, in patients treated with this drug.
* Determine the survival of patients treated with this drug.
* Determine the effects of this drug on biomarkers of melanoma in these patients.
* Correlate biomarker levels with response in patients treated with this drug.
OUTLINE: This is an open-label, multicenter study. Patients are assigned to 1 of 2 treatment cohorts according to prior cytotoxic chemotherapy (previously treated vs chemotherapy-naïve).
* Cohort I (previously treated): Patients receive ABI-007 IV over 30 minutes on days 1, 8, and 15.
* Cohort II (chemotherapy-naïve): Patients receive a higher dose of ABI-007 as in cohort I.
In both cohorts, courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 6 months and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 24-70 patients (12-35 per cohort) will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States