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Bevacizumab (rhuMab VEGF) (NSC-704865) Therapy for Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma

Phase 2
19 Years
Not Enrolling
Anaplastic Large Cell Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Mantle Cell Lymphoma

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Trial Information

Bevacizumab (rhuMab VEGF) (NSC-704865) Therapy for Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma


I. To estimate the 6-month progression-free survival rate in patients with relapsed
aggressive NHL treated with single agent bevacizumab therapy.

II. To evaluate response rate and toxicity in patients with relapsed aggressive NHL treated
with this regimen.

III. To measure tumor VEGF and VEGF receptor 1 and 2 expression (Flt-1 and Flk-1/KDR) and to
explore the correlation between expression level and histology and response.

IV. To measure pre-therapy, week 8 and time to progression biologic measures of VEGF
activity including plasma VEGF levels, urinary VEGF levels, and circulating number of
endothelial cells and explore the correlation with response.


Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every
28 days for a maximum of 24 courses in the absence of disease progression or unacceptable

Patients are followed every 6 months for 3 years

Inclusion Criteria:

- Patients must have biopsy proven relapsed (first or second relapse) non-Hodgkin's
lymphoma, aggressive histology of one of the following histologic subtypes;
transformed non-Hodgkin's lymphoma patients are not eligible for this study:

- Diffuse large (formerly Working Formulation Groups F, G, H)

- High-grade, Burkitt's or Burkitt-like

- Primary mediastinal

- Anaplastic large cell

- Mantle cell

- Note: patients being registered to this study at first relapse must not be
suitable for transplant or aggressive treatment at first relapse

- Patients must have measurable disease; all techniques used to measure disease must be
completed within 28 days prior to registration and must have been done after
completion of prior therapy

- Patients must have had a chest x-ray or CT scan of the chest and a CT scan of the
abdomen and pelvis within 28 days prior to registration and they must have been done
after completion of prior chemotherapy

- Patients must have either a unilateral or bilateral bone marrow aspirate and biopsy
within 42 days prior to registration

- Patients must have had 1 or 2 prior chemotherapy regimens (pre-induction and
autologous bone marrow transplantation will be considered as one prior therapy) for
lymphoma; this includes investigational agents and/or other antibody therapies; all
prior therapy must have been completed at least 2 weeks prior to registration; due to
possible interactions with the rituximab antibody; patients previously receiving
rituximab must have completed rituximab therapy at least 12 weeks prior to
registration; if rituximab is given as a single agent after a relapse, it is
considered a separate regimen and will be counted as such; if the rituximab is given
in combination for either the first or second relapse or as consolidation after
chemotherapy regimen without an intervening relapse, it will be considered part of
the combination regimen and counted as one prior therapy; patients must have
recovered from any chemotherapy-related toxicities prior to registration

- Patient must not have undergone major surgery within 4 weeks prior to registration
(this does not apply to placement of venous access device) or received any
radiotherapy within 2 weeks prior to registration

- Patients must not be receiving or planning to receive oral steroids for any condition
at the time of registration; use of a steroid inhaler or nasal spray is allowed

- Patients must not require chronic use of oral or parenteral anticoagulants (other
than that used to maintain patency of an indwelling IV catheter) or anti-platelet
therapy > 325 mg per day of aspirin

- Patients must not have any acute healing bone fracture

- Patients must not have a history of uncontrolled seizures

- A pretreatment sample of plasma whole blood, bone marrow (if there is bone marrow
involvement with lymphoma) urine and unstained diagnostic paraffin slides must be
submitted for correlative studies)

- All patients must have a performance status of 0, 1 or 2 according to Zubrod criteria

- Patients must not have central nervous system involvement with lymphoma

- ANC >= 500

- Platelets >= 75,000

- Hematocrit >= 28%

- Prothrombin time (PT) =< 2 seconds of the institutional upper limit of normal (IULN)
and partial prothrombin time (PTT) =< IULN within 14 days prior to registration

- Serum creatinine =< 1.5 mg/dl or measured creatinine clearance >= 60 mL/min

- Patients must have a 24 hour proteinuria =< 500mg/24hours

- Total bilirubin < 2.0 mg/dl

- SGOT/SGPT =< 5 x IULN for subjects with documented liver metastasis or < 2.5 x IULN
for subjects without evidence of liver metastasis

- Patients must not have uncompensated coronary artery disease on electrocardiogram or
physical exam, or history of previous thromboembolic events, including transient
ischemic attack (TIA), cerebrovascular accident (CVA), myocardial infarction (MI),
unstable angina, or uncontrolled atrial fibrillation in the past 6 months

- Patients must not have uncontrolled hypertension

- Patients must not have clinical evidence of peripheral vascular disease, diabetic
ulcers or venous stasis, ulcers, or a history of deep venous or arterial thrombosis
within the last 3 months

- Patients with known AIDS syndrome or HIV associated complex are not eligible

- Pregnant or nursing women may not participate; women and men of reproductive
potential may not participate unless they have agreed to use an effective
contraceptive method

- No prior malignancy is allowed except for adequately treated basal cell or squamous
cell skin cancer, in situ cervical cancer, or other cancer for which the patient has
been disease-free for 5 years

- If day 1, 28, or 42 falls on a weekend of holiday, the limit may be extended to the
next working day; in calculating days of tests and measurements, the day a test or
measurement is done is considered day 0; therefore, if a test is done on a Monday,
the Monday 2 weeks later would be considered day 14; this allows for efficient
patient scheduling without exceeding the guidelines

- All patients must be informed of the investigational nature of this study and give
written informed consent in accordance with institutional and federal guidelines

- At the time of patient registration, the treating institution's name and ID number
must be provided to the statistical center in order to ensure that the current
(within 365 days) date of institutional review board approval for this study has been
entered into the database

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival rate in patients treated with single agent bevacizumab

Outcome Description:

A 6-month progression-free survival estimate of 40% or greater will indicate that further investigation of this therapy at this dose and schedule is warranted.

Outcome Time Frame:

Date of registration to date of first observation of progressive disease, or death due to any cause, assessed up to 6 months

Safety Issue:


Principal Investigator

Alison Stopeck

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

April 2001

Completion Date:

September 2008

Related Keywords:

  • Anaplastic Large Cell Lymphoma
  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Burkitt Lymphoma
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Mantle-Cell



Southwest Oncology Group San Antonio, Texas  78245