Protein Tyrosine Kinases (PTK) in Multiple Myeloma

NCT ID: NCT00165347

Last Updated: 2007-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2006-10-31

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 month of treatment.

Physical exam, vital signs, blood work, a quality of life assessment, and x-ray or MRI wil be performed every 4 weeks.

Patients will remain on the study until their disease fails to respond to treatment or there are intolerable side effects. Typically treatment is performed for 12 weeks and up to one year in patients that are stable and responding.

Conditions

Multiple Myeloma

Keywords

Multiple myeloma; PTK; Relapsed multiple myeloma; Refractory Multiple myeloma; Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

PTK787/ZK222584

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Principal Investigators

Nikhil Munshi, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

03-257

Identifier Type: -

Identifier Source: org_study_id