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Anaplastic Large Cell LymphomaPhase 2NCT00016094

S0108 Bevacizumab in Treating Patients With Non-Hodgkin's Lymphoma

A Phase 2 study testing bevacizumab and laboratory biomarker analysis in people with Anaplastic Large Cell Lymphoma and Recurrent Adult Burkitt Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase II trial to study the effectiveness of bevacizumab in treating patients who have non-Hodgkin's lymphoma. Monoclonal antibodies such as bevacizumab may stop the growth of cancer by stopping blood flow to the tumor. Bevacizumab may be an effective treatment for non-Hodgkin's lymphoma Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
bevacizumab and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
Apr 2001to Sep 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 36Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Southwest Oncology Group

    San Antonio, Texas, 78245

Other trials in United States

About this study

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

Phase II trial to study the effectiveness of bevacizumab in treating patients who have non-Hodgkin's lymphoma. Monoclonal antibodies such as bevacizumab may stop the growth of cancer by stopping blood flow to the tumor. Bevacizumab may be an effective treatment for non-Hodgkin's lymphoma

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

OUTLINE:

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 toxicity.

Patients are followed every 6 months for 3 years

Being tested
bevacizumab, laboratory biomarker analysis
Medical subject headings
Lymphoma, Large-Cell, Anaplastic, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bevacizumabBiological

    Also called anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00016094
Study groupRoleWhat they receive
Treatment (bevacizumab)ExperimentalPatients 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 toxicity.
Receives: Biological: bevacizumab; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startApr 2001
  3. Primary completionAug 2005
  4. Study completionSep 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00016094
Sponsor's protocol ID
NCI-2012-03039
Other IDs
S0108, U10CA032102, CDR0000068594
Status last verified
Jan 2013
First submitted
6 May 2001
Last updated
29 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab and laboratory biomarker analysis in people with Anaplastic Large Cell Lymphoma and Recurrent Adult Burkitt Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival rate in patients treated with single agent bevacizumab (time frame: Date of registration to date of first observation of progressive disease, or death due to any cause, assessed up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00016094.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2013.

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