CC-4047 in Treating Patients With Advanced Solid Tumors That Did Not Respond to Treatment
RATIONALE: CC-4047 may stop the growth of tumor cells by blocking blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of CC-4047 in treating patients with advanced solid tumors that did not respond to treatment.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I, Open-Label Study to Determine the Maximum Tolerated Dose (MTD) and to Evaluate the Safety Profile of CC-4047 in Subjects With Advanced Solid Tumors|
- Maximum tolerated dose [ Time Frame: after initial 28 day cycle ]To determine the maximum tolerated dose (MTD) of daily CC-4047 in an initial 28-day cycle (21 days of CC-4047 followed by 7 days of no therapy) in subjects with advanced solid tumors (Cohort A).
- Dose-limiting toxicity [ Time Frame: Courses repeat every 28 days for up to 24 months in the absence of unacceptable toxicity. ]
- Tumor response as assessed by RECIST criteria [ Time Frame: after every 2 courses (28 days/ course) ]
- Duration of response [ Time Frame: Courses repeat every 28 days for up to 24 months in the absence of disease progression. ]
- Fetal hemoglobin levels as assessed thereafter [ Time Frame: at baseline and every 28 days thereafter ]
|Study Start Date:||March 2007|
|Study Completion Date:||August 2012|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Oral CC-4047 once daily on days 1-21 followed by a 7-day recovery period. Cohorts of 3-6 patients receive escalating doses of CC-4047 until the maximum tolerated dose (MTD) is determined.
- Determine the maximum tolerated dose of CC-4047 in patients with advanced refractory solid tumors.
- Assess the safety of this drug in these patients.
- Assess the antitumor activity of this drug in these patients.
- Determine the effect of this drug on fetal hemoglobin levels in these patients.
OUTLINE: This is a open-label, uncontrolled, nonrandomized, dose-escalation, multicenter study.
- Treatment phase (course 1): Patients receive oral CC-4047 once daily on days 1-21 followed by a 7-day recovery period.
Cohorts of 3-6 patients receive escalating doses of CC-4047 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT).
Patients with no clinical evidence of progressive disease or DLT after course 1 continue study treatment during the extension phase. Patients who develop a DLT during course 1 may continue study treatment at the discretion of the investigator.
- Extension phase: Patients continue taking CC-4047 at their assigned cohort dose as in course 1. Patients who tolerate a treatment-phase dose higher than the MTD continue treatment at the MTD. Courses repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection at baseline and periodically during study to evaluate fetal hemoglobin levels.
After completion of study treatment, patients are followed at 28 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482521
|United States, Ohio|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Study Chair:||Matthew M. Cooney, MD||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Principal Investigator:||Robert Dreicer, MD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|