Status:
COMPLETED
Protein Tyrosine Kinases (PTK) in Multiple Myeloma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Novartis
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether or not cancer cells in the body are affected by PTK and whether it affects the growth of these cells.
Detailed Description
Patients will take PTK orally once a day for the duration of their time on the study. Each cycle of chemotherapy will last for 4 weeks. Measurement of vital signs will be done weekly during the first...
Eligibility Criteria
Inclusion
- Older than 18 years of age.
- Confirmed diagnosis of active progressive multiple myeloma
- History of \> 2 prior cytotoxic treatment regimens. Bone marrow transplantation will be considered as one regimen.
- Current measurable disease based on serum and/or urine M protein and/or measurable plasmacytoma.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Absolute neutrophil count (ANC) \> 1,500 mm3
- Platelets \> 100,000 mm3
- Serum creatinine \< 1.5 upper limit of normal (ULN)
- Serum bilirubin \< 1.5 ULN
- AST/AGOT and ALT/SGPT \< 3.0 ULN
- Life expectancy \> 12 weeks
Exclusion
- Chemotherapy \< 3 weeks prior to registration.
- Biologic or immunotherapy \< 2 weeks prior to registration
- Full field radiotherapy \< 4 weeks or limited field radiotherapy \< 2 weeks prior to registration.
- History or presence of central nervous system (CNS) disease
- History of leukemia
- History of another primary malignancy with the exception of inactive basal or squamous cell carcinoma of the skin
- Major surgery \< 4 weeks prior to registration
- Prior therapy with anti-vascular endothelial growth factor (VEGF) agents excluding thalidomide, Revimid, velcade and arsenic trioxide
- Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
- Pleural effusion or ascites that cause respiratory compromise
- Female patients that are pregnant or breast feeding
- Uncontrolled high blood pressure, history of labile hypertension or history of poor compliance with an antihypertensive regimen
- Unstable angina pectoris
- Symptomatic congestive heart failure
- Myocardial infarction \< 6 months prior to registration
- Serious uncontrolled cardiac arrhythmia
- Uncontrolled diabetes
- Active or uncontrolled infection
- Acute or chronic liver disease
- Impairment of gastrointestinal (GI) function or GI disease
- Confirmed HIV infection
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00165347
Start Date
December 1 2003
End Date
October 1 2006
Last Update
December 21 2007
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115