- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00511043
PTK787 in Refractory or Relapsed Diffuse Large Cell Lymphoma
Phase II Open Label Study of PTK787/ZK222584 in Adults Patients With Refractory or Relapsed Diffuse Large Cell Lymphoma
Study Overview
Detailed Description
In order for tumors to grow and spread to other parts of the body, they need to have a growing blood supply. Tumor cells have been shown to produce substances that stimulate the abnormal growth of new blood vessels that allow the tumor to grow. In adults, blood vessel cells normally divide very rapidly. It is thought that PTK787/ZK222584 may interfere with the growth of new blood vessels. A drug that interferes with the growth of new blood vessels might stop tumor growth, and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels. Since normal blood vessel cells divide very rapidly, it might be possible to stop tumor growth without harming normal tissues.
The purpose of this study is to find out if an investigational drug, PTK787/ZK 222584 is safe and effective in treating relapsed or refractory diffuse large cell lymphoma.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
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Columbia, North Carolina, United States, 29210
- South Carolina Oncology Associates
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically confirmed DLCL (de novo or transformed).
- Measurable/evaluable disease by radiographs, physical exam or bone marrow involvement.
- Refractory disease, induction chemotherapy failure or relapsed disease.
- Age ≥ 18 years old
- Performance Status:KPS ≥ 70
- Laboratory tests as specified by the protocol.
- Written informed consent
Exclusion Criteria:
- History of known central nervous system disease (i.e., primary brain tumor, malignant seizures, CNS metastases or carcinomatous meningitis).
- History of another primary malignancy ≤ 5 years, with the exception of inactive basal or squamous cell carcinoma of the skin
- Prior chemotherapy ≤ 3 weeks prior to registration. There is no limit to the number of prior chemotherapy regimens.
- Prior allogeneic transplant if >2.5% donor cells remain by engraftment studies (prior autologous transplant is allowed)
- Prior biologic or immunotherapy ≤ 2 weeks prior to registration.
- Prior full field (total organ site) radiotherapy ≤ 4 weeks or limited field radiotherapy ≤ 2 weeks prior to registration.
- Major surgery (i.e., laparotomy) ≤ 4 weeks prior to registration. Minor surgery ≤ 2 weeks prior to registration.
- Patients who have received investigational drugs ≤ 4 weeks prior to registration and/or registration
- Prior therapy with anti-VEGF targeted agents
- Pleural effusion or ascites that causes respiratory compromise (≥ CTC grade 2 dyspnea)
- QTc > 450 (male) or > 470 (female). Patients with congenital or acquired prolonged QTc syndrome
- Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control.
Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
- 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
- Severe active or uncontrolled infection
- Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
- Chronic renal disease with documented nephritic or nephrotic syndrome.
- Acute or chronic liver disease
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PTK787/ZK222584
- Patients with confirmed diagnosis of human immunodeficiency virus (HIV) infection are excluded at the investigator's discretion if he/she feels that 1) a potential drug interaction between PTK787/ZK 222584 and anti-HIV medications that could influence the efficacy of the anti-HIV medication, or 2) it may place the patient at risk due to the pharmacologic activity of PTK787/ZK 222584.
- Patients who are taking therapeutic warfarin sodium (Coumadin) or similar oral anticoagulants that are metabolized by the cytochrome P450 system.
- Patients unwilling to or unable to comply with the protocol
- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: All pts
PTK787
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PTK787 - 1250mg p.o. daily.
Initial dose of 750mg p.o daily starting on day 1 and increased weekly to an intermediate dose of 1000 mg and then a target dose of 1250mg unless a grade ≥ 2 toxicity.
Patients who tolerate the study target dose of 1250mg will remain on that dose until study completion at 12 months or until disease progression, unacceptable toxicity, withdrawal of consent or patient non-compliance with the protocol requirement.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response
Time Frame: approximately 1 year
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approximately 1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety
Time Frame: 30 days post last dose of study drug
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30 days post last dose of study drug
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell
- Lymphoma
- Lymphoma, Large B-Cell, Diffuse
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protein Kinase Inhibitors
- Vatalanib
Other Study ID Numbers
- Pro00008648
- CPTK787AUS39
- 7416 (Other Identifier: Legacy Duke IRB number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lymphoma, Large-Cell, Diffuse
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National Cancer Institute (NCI)WithdrawnDiffuse, Large B-cell Lymphoma | Lymphoma, Diffuse Large-Cell | Lymphoma, Diffuse Large-Cell B-cell | Large-Cell Lymphoma, Diffuse
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Memorial Sloan Kettering Cancer CenterRecruitingLymphoma | Lymphoma, B-Cell | DLBCL - Diffuse Large B Cell Lymphoma | Large B-cell Lymphoma | Large-cell Lymphoma | Mediastinal B-Cell Diffuse Large Cell LymphomaUnited States
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Roswell Park Cancer InstituteNational Cancer Institute (NCI); AmgenActive, not recruitingRecurrent Diffuse Large B-Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | CD20 Positive | Stage I Diffuse Large B-Cell Lymphoma | Stage II Diffuse Large B-Cell Lymphoma | Stage III Diffuse Large B-Cell Lymphoma | Stage IV Diffuse Large B-Cell LymphomaUnited States
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University of NebraskaNational Cancer Institute (NCI); Genta IncorporatedTerminatedStage III Adult Diffuse Large Cell Lymphoma | Stage IV Adult Diffuse Large Cell Lymphoma | Contiguous Stage II Adult Diffuse Large Cell Lymphoma | Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma | Stage I Adult Diffuse Large Cell LymphomaUnited States
-
Fox Chase Cancer CenterGenentech, Inc.WithdrawnStage III Adult Diffuse Large Cell Lymphoma | Stage IV Adult Diffuse Large Cell Lymphoma | Contiguous Stage II Adult Diffuse Large Cell Lymphoma | Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma | Stage I Adult Diffuse Large Cell LymphomaUnited States
-
Case Comprehensive Cancer CenterActive, not recruitingStage III Adult Diffuse Large Cell Lymphoma | Stage IV Adult Diffuse Large Cell Lymphoma | Contiguous Stage II Adult Diffuse Large Cell Lymphoma | Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma | Stage I Adult Diffuse Large Cell LymphomaUnited States
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University Hospital Southampton NHS Foundation...Hoffmann-La RocheTerminatedDiffuse Large B Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Relapsed Diffuse Large B-Cell LymphomaUnited Kingdom
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National Cancer Institute (NCI)CompletedStage III Adult Diffuse Large Cell Lymphoma | Stage IV Adult Diffuse Large Cell Lymphoma | Contiguous Stage II Adult Diffuse Large Cell Lymphoma | Noncontiguous Stage II Adult Diffuse Large Cell LymphomaUnited States
-
National Cancer Institute (NCI)TerminatedStage III Adult Diffuse Large Cell Lymphoma | Stage IV Adult Diffuse Large Cell Lymphoma | Contiguous Stage II Adult Diffuse Large Cell Lymphoma | Noncontiguous Stage II Adult Diffuse Large Cell LymphomaUnited States
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National Cancer Institute (NCI)CompletedRecurrent Adult Diffuse Large Cell Lymphoma | Stage IV Adult Diffuse Large Cell Lymphoma | Adult Diffuse Large Cell LymphomaCanada
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