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CI-994 in Treating Patients With Advanced Myeloma

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CI-994
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring refractory multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, plasma cell neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • H. Lee Moffitt Cancer Center and Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CI-994 Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)
Response Rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

Secondary Outcome Measures

Duration of Response
Response of duration in months
Number of Participants with Overall Survival (OS)
Participants surviving at end of study.
Number of Participants with Adverse Events
Review of adverse events utilizing Common Toxicity Criteria (CTC) V3.

Full Information

First Posted
May 2, 2000
Last Updated
September 21, 2012
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI), Parke-Davis
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1. Study Identification

Unique Protocol Identification Number
NCT00005624
Brief Title
CI-994 in Treating Patients With Advanced Myeloma
Official Title
A Multicenter Phase 2 Study of Oral N-Acetyl Dinaline (CI-994) in the Treatment of Patients With Advanced Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
August 1997 (undefined)
Primary Completion Date
February 2003 (Actual)
Study Completion Date
February 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI), Parke-Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
refractory multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, plasma cell neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CI-994 Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CI-994
Other Intervention Name(s)
Oral N-Acetyl Dinaline, Tacedinaline, HDAC Inhibitor, CAS 112522-64-2, Acetyldinaline, PD 123654
Intervention Description
CI-994 as outlined in treatment arm.
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
Response Rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Duration of Response
Description
Response of duration in months
Time Frame
5 years
Title
Number of Participants with Overall Survival (OS)
Description
Participants surviving at end of study.
Time Frame
5 years
Title
Number of Participants with Adverse Events
Description
Review of adverse events utilizing Common Toxicity Criteria (CTC) V3.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Alsina, M.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

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CI-994 in Treating Patients With Advanced Myeloma

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