CI-994 in Treating Patients With Advanced Myeloma
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|ClinicalTrials.gov Identifier: NCT00005624|
Recruitment Status : Completed
First Posted : July 26, 2004
Last Update Posted : September 25, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: CI-994||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Phase 2 Study of Oral N-Acetyl Dinaline (CI-994) in the Treatment of Patients With Advanced Myeloma|
|Study Start Date :||August 1997|
|Actual Primary Completion Date :||February 2003|
|Actual Study Completion Date :||February 2003|
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.
- Overall Response Rate (ORR) [ Time Frame: 5 years ]Response Rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
- Duration of Response [ Time Frame: 5 years ]Response of duration in months
- Number of Participants with Overall Survival (OS) [ Time Frame: 5 years ]Participants surviving at end of study.
- Number of Participants with Adverse Events [ Time Frame: 5 years ]Review of adverse events utilizing Common Toxicity Criteria (CTC) V3.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|