CI-994 in Treating Patients With Advanced Myeloma

Multiple Myeloma Clinical Trial

Official title:

A Multicenter Phase 2 Study of Oral N-Acetyl Dinaline (CI-994) in the Treatment of Patients With Advanced Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005624
• Other study ID #: MCC-11560
• Secondary ID: PD-994-04NCI-G00
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2000
• Last updated: September 21, 2012
• Start date: August 1997
• Est. completion date: February 2003

Study information

• Verified date: September 2012
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 2003
• Est. primary completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS: Histologically confirmed stage IIA or IIIA myeloma with a measurable M- component in the serum or urine Progressing disease after conventional chemotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:

Greater than 8 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 75,000/mm3 (transfusion independent) Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST/ALT no greater than 2 times ULN Renal: Creatinine no greater than 1.5 times ULN Calcium no greater than 12 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No life threatening illness unrelated to the tumor No concurrent serious infection No prior malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix Must be capable of swallowing intact medication capsules No medical or psychiatric condition that would prevent written informed consent

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 14 days since prior immunologic agents No concurrent immunologic agents Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 2 weeks since prior high dose corticosteroids No concurrent anticancer hormonal therapy No concurrent corticosteroids Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• CI-994
CI-994 as outlined in treatment arm.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Cancer Institute (NCI), Parke-Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	Response Rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.	5 years	No
Secondary	Duration of Response	Response of duration in months	5 years	No
Secondary	Number of Participants with Overall Survival (OS)	Participants surviving at end of study.	5 years	No
Secondary	Number of Participants with Adverse Events	Review of adverse events utilizing Common Toxicity Criteria (CTC) V3.	5 years	Yes