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Phase II Open Label Study of PTK787/ZK222584 in Adults Patients With Refractory or Relapsed Diffuse Large Cell Lymphoma

Phase 2
18 Years
Not Enrolling
Lymphoma, Large-Cell, Diffuse

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Trial Information

Phase II Open Label Study of PTK787/ZK222584 in Adults Patients With Refractory or Relapsed Diffuse Large Cell Lymphoma

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.

Inclusion Criteria:

- Histologically confirmed DLCL (de novo or transformed).

- Measurable/evaluable disease by radiographs, physical exam or bone marrow

- 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

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

approximately 1 year

Safety Issue:


Principal Investigator

David A Rizzieri, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Food and Drug Administration

Study ID:

Pro00008648 (7416)



Start Date:

November 2005

Completion Date:

June 2010

Related Keywords:

  • Lymphoma, Large-Cell, Diffuse
  • PTK787
  • DLCL
  • Diffuse large cell lymphoma
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin



Duke University Medical CenterDurham, North Carolina  27710
University of North Carolina at Chapel HillChapel Hill, North Carolina  27599
South Carolina Oncology AssociatesColumbia, North Carolina  29210