Overview

Phase II Evaluation of FTase Inhibitor (FTI)in Treatment of Advanced Multiple Myeloma

Status:
Completed
Trial end date:
2010-01-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have relapsed or refractory multiple myeloma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborators:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Treatments:
Tipifarnib
Criteria
DISEASE CHARACTERISTICS: Diagnosis of relapsed or refractory multiple myeloma confirmed by
the presence of the following: Bone marrow plasmacytosis with at least 10 percent plasma
cells Sheets of plasma cells OR Biopsy-proven plasmacytoma Documentation of at least one of
the following criteria: Serum myeloma (M)-protein component at least 1.0 g/dL by serum
protein electrophoresis Urine M-protein excretion more than 200 mg/24 hours by urine
protein electrophoresis Stage IIA or IIIA disease Measurable disease The following are not
considered measurable disease: Lytic bone lesions Anemia Bone marrow plasmacytosis Beta-2
microglobulin in serum Previously treated with conventional chemotherapy Progressing or
relapsing disease at time of study

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Eastern Cooperative Oncology
Group (ECOG) 0-3 Life expectancy: More than 8 weeks Hematopoietic: Absolute neutrophil
count at least 1,000/mm^3 Hepatic: aspartate aminotransferase (AST) or alanine transaminase
(ALT) no greater than 2 times upper limit of normal (ULN) Bilirubin no greater than 2 mg/dL
Renal: Creatinine no greater than 1.5 times ULN Calcium no greater than 12 mg/dL Other: Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception Capable of swallowing intact study medication tablets No concurrent serious
infection No grade 3 or greater peripheral neuropathy No life-threatening illness unrelated
to tumor No other active or invasive cancer within the past 3 years except nonmelanoma skin
cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior thalidomide allowed At least 14 days
since prior immunologic agents No concurrent immunologic agents Chemotherapy: See Disease
Characteristics At least 3 weeks since prior cytotoxic chemotherapy No other concurrent
cytotoxic therapy Endocrine therapy: At least 14 days since prior high-dose corticosteroids
No concurrent hormonal therapy No concurrent corticosteroids Radiotherapy: At least 3 weeks
since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified
Other: No other concurrent cancer therapy Concurrent pamidronate or other bisphosphonates
allowed