Phase II Evaluation of FTI (R115777) (NSC 702818) in Treatment of Advanced Multiple Myeloma
18 Years
N/A
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
Phase II Evaluation of FTI (R115777) (NSC 702818) in Treatment of Advanced Multiple Myeloma
OBJECTIVES:
- Determine the objective response rate and disease-stabilization rate in patients with
relapsed or refractory multiple myeloma treated with R115777.
- Determine whether the degree of inhibition of FTase activity and farnesylation of
lamin-B, H-RAS, K-RAS, and N-RAS in peripheral blood mononuclear cells (PBMC) and tumor
tissue correlates with tumor response in patients treated with this drug.
- Determine whether the presence of activating RAS mutations in myeloma cells correlates
with disease response in patients treated with this drug.
- Correlate R115777 plasma levels, degree of farnesylation inhibition in PBMC and tumor
tissue, and RAS mutation status with tumor response in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral R115777 twice daily on days 1-21. Treatment repeats every 4 weeks in
the absence of disease progression or unacceptable toxicity.
Patients are followed every 4 weeks.
PROJECTED ACCRUAL: A total of 12-42 patients will be accrued for this study within 8-25
months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of relapsed or refractory multiple myeloma
- Bone marrow plasmacytosis with at least 10% plasma cells, sheets of plasma
cells, or biopsy-proven plasmacytoma
- Myeloma (M)-protein in serum or urine
- Stage IIA or IIIA
- Previously treated with conventional chemotherapy
- Measurable disease
- Serum M-protein component at least 1.0 g/dL OR
- Urine M-protein excretion greater than 200 mg/24 hours
- The following are not considered measurable disease:
- Lytic bone lesions
- Anemia
- Bone marrow plasmacytosis
- Beta-2 microglobulin in serum
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-3
Life expectancy:
- More than 8 weeks
Hematopoietic:
- Absolute neutrophil count at least 1,000/mm^3
Hepatic:
- Bilirubin no greater than 2 mg/dL
- AST or ALT no greater than 2 times upper limit of normal (ULN)
Renal:
- Creatinine no greater than 1.5 times ULN
- Calcium no greater than 12 mg/dL
Other:
- Capable of swallowing intact tablets
- No other life-threatening illness unrelated to tumor
- No concurrent serious infection
- No other active or invasive malignancy within the past 3 years except nonmelanoma
skin cancer
- No peripheral neuropathy grade 3 or greater
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 forms of effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 2 weeks since prior immunologic agents
- Prior thalidomide allowed
- No concurrent immunotherapy
Chemotherapy:
- See Disease Characteristics
- At least 3 weeks since prior cytotoxic chemotherapy
- No other concurrent cytotoxic therapy
Endocrine therapy:
- At least 2 weeks since prior high-dose corticosteroids
- No concurrent corticosteroids
- No concurrent hormonal therapy
Radiotherapy:
- At least 3 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- Not specified
Other:
- Concurrent pamidronate or other bisphosphonates allowed
- No concurrent anticancer therapy
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Melissa Alsina, MD
Investigator Role:
Study Chair
Investigator Affiliation:
H. Lee Moffitt Cancer Center and Research Institute
Authority:
United States: Federal Government
Study ID:
CDR0000068759
NCT ID:
NCT00021203
Start Date:
January 2001
Completion Date:
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- refractory multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
Name | Location |
|---|---|
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
