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


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Response Rate (ORR)

Outcome Description:

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

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Melissa Alsina, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Federal Government

Study ID:

MCC-11560

NCT ID:

NCT00005624

Start Date:

August 1997

Completion Date:

February 2003

Related Keywords:

  • Multiple Myeloma
  • refractory multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • plasma cell neoplasm
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612