Clinical trial NCT00165347: Protein Tyrosine Kinases (PTK) in Multiple Myeloma
Official title: Phase II Study of PTK787/ZK222584 in Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Multiple myeloma
PTK
Relapsed multiple myeloma
Refractory Multiple myeloma
Myeloma
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Novartis
First posted: 2005-09-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To determine the effectiveness of PTK in treating patients with relapsed or refractory myeloma
Secondary outcomes:
measure: To evaluate the progression free survival of patients treated with PTK
measure: to investigate the safety of PTK in patients with relapsed/refractory multiple myeloma
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Nikhil Munshi, MD
role: PRINCIPAL_INVESTIGATOR
References: