CI-994 in Treating Patients With Advanced Myeloma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of CI-994 in treating patients who have advanced myeloma.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter Phase 2 Study of Oral N-Acetyl Dinaline (CI-994) in the Treatment of Patients With Advanced Myeloma|
- Overall Response Rate (ORR) [ Time Frame: 5 years ] [ Designated as safety issue: No ]Response Rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
- Duration of Response [ Time Frame: 5 years ] [ Designated as safety issue: No ]Response of duration in months
- Number of Participants with Overall Survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]Participants surviving at end of study.
- Number of Participants with Adverse Events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]Review of adverse events utilizing Common Toxicity Criteria (CTC) V3.
|Study Start Date:||August 1997|
|Study Completion Date:||February 2003|
|Primary Completion Date:||February 2003 (Final data collection date for primary outcome measure)|
Experimental: CI-994 Treatment
Patients receive CI-994 orally daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed for 30 days and then every 2 months.
CI-994 as outlined in treatment arm.
OBJECTIVES: I. Determine the antitumor activity of CI-994 in patients with advanced myeloma. II. Determine the response rate, response duration, and overall survival of this patient population with this treatment regimen. III. Determine the safety of this treatment in these patients.
OUTLINE: This is a multicenter study. Patients receive CI-994 orally daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed for 30 days and then every 2 months.
PROJECTED ACCRUAL: A total of 8-63 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005624
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Melissa Alsina, M.D.||H. Lee Moffitt Cancer Center and Research Institute|