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Protein Tyrosine Kinases (PTK) in Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PTK787/ZK222584
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple myeloma, PTK, Relapsed multiple myeloma, Refractory Multiple myeloma, Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dana-Farber Cancer Institute

Outcomes

Primary Outcome Measures

To determine the effectiveness of PTK in treating patients with relapsed or refractory myeloma

Secondary Outcome Measures

To evaluate the progression free survival of patients treated with PTK
to investigate the safety of PTK in patients with relapsed/refractory multiple myeloma

Full Information

First Posted
September 9, 2005
Last Updated
December 20, 2007
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00165347
Brief Title
Protein Tyrosine Kinases (PTK) in Multiple Myeloma
Official Title
Phase II Study of PTK787/ZK222584 in Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Novartis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple myeloma, PTK, Relapsed multiple myeloma, Refractory Multiple myeloma, Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
PTK787/ZK222584
Primary Outcome Measure Information:
Title
To determine the effectiveness of PTK in treating patients with relapsed or refractory myeloma
Secondary Outcome Measure Information:
Title
To evaluate the progression free survival of patients treated with PTK
Title
to investigate the safety of PTK in patients with relapsed/refractory multiple myeloma

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikhil Munshi, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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Protein Tyrosine Kinases (PTK) in Multiple Myeloma

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