Full Text View
Tabular View
No Study Results Posted
Related Studies
Bevacizumab in Treating Patients With Non-Hodgkin's Lymphoma
This study has been completed.
Study NCT00016094   Information provided by National Cancer Institute (NCI)
First Received: May 6, 2001   Last Updated: April 21, 2009   History of Changes

May 6, 2001
April 21, 2009
April 2001
September 2008   (final data collection date for primary outcome measure)
  • 6-month progression-free survival rate [ Designated as safety issue: No ]
  • Response rate [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Correlation of tumor vascular endothelial growth factor (VEGF) and VEGF receptor 1 and 2 expression with histology and response [ Designated as safety issue: No ]
  • Correlation of biologic measures of VEGF activity with response [ Designated as safety issue: No ]
  • 6-month progression-free survival rate
  • Response rate
  • Toxicity
  • Correlation of tumor vascular endothelial growth factor (VEGF) and VEGF receptor 1 and 2 expression with histology and response
  • Correlation of biologic measures of VEGF activity with response
Complete list of historical versions of study NCT00016094 on ClinicalTrials.gov Archive Site
 
 
 
Bevacizumab in Treating Patients With Non-Hodgkin's Lymphoma
Bevacizumab (rhuMAb VEGF) Therapy For Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma

RATIONALE: 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

PURPOSE: Phase II trial to study the effectiveness of bevacizumab in treating patients who have non-Hodgkin's lymphoma.

OBJECTIVES:

  • Determine the 6-month progression-free survival rate and response rate in patients with relapsed aggressive non-Hodgkin's lymphoma treated with bevacizumab.
  • Determine the toxicity of this drug in these patients.
  • Correlate tumor vascular endothelial growth factor (VEGF) and VEGF receptor 1 and 2 expression with histology and response in patients treated with this drug.
  • Correlate biologic measures of VEGF activity with response in patients treated with this drug.

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.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.

Phase II
Interventional
Treatment
Lymphoma
Biological: bevacizumab
 
Stopeck AT, Unger JM, Rimsza LM, Bellamy WT, Iannone M, Persky DO, Leblanc M, Fisher RI, Miller TP. A phase II trial of single agent bevacizumab in patients with relapsed, aggressive non-Hodgkin lymphoma: Southwest oncology group study S0108. Leuk Lymphoma. 2009 Apr 15;:1-8 [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
September 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed aggressive non-Hodgkin's lymphoma (NHL)

    • Diffuse large cell
    • High-grade Burkitt's or Burkitt-like
    • Primary mediastinal
    • Anaplastic large cell
    • Mantle cell
  • No transformed NHL
  • Relapsed disease (first or second relapse) after 1 or 2 prior chemotherapy regimens (including investigational agents and/or other antibody therapies) for lymphoma

    • Pre-induction and autologous bone marrow transplantation are considered as 1 prior therapy
    • Rituximab given in combination with or as consolidation after a chemotherapy regimen (without an intervening relapse) is considered 1 prior therapy (rituximab given as a single agent after relapse is considered a separate regimen)
  • Must not be suitable for transplantation or aggressive treatment if in first relapse
  • Bidimensionally measurable disease
  • No CNS involvement by lymphoma

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 500/mm^3
  • Platelet count at least 75,000/mm^3
  • Hematocrit at least 28%

Hepatic:

  • PT no greater than 2 seconds of upper limit of normal (ULN)
  • PTT no greater than ULN
  • Bilirubin less than 2.0 mg/dL
  • SGOT/SGPT less than 2.5 times ULN (no greater than 5 times ULN if evidence of liver metastasis)

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min
  • Proteinuria no greater than 500 mg by 24-hour urine collection

Cardiovascular:

  • No uncompensated coronary artery disease by EKG or physical examination
  • No transient ischemic attack within the past 6 months
  • No cerebrocardiovascular accident within the past 6 months
  • No myocardial infarction within the past 6 months
  • No unstable angina within the past 6 months
  • No uncontrolled atrial fibrillation within the past 6 months
  • No other arterial thromboembolic event within the past 6 months
  • No uncontrolled hypertension
  • No clinical evidence of severe peripheral vascular disease
  • No venous stasis ulcers
  • No prior deep venous or arterial thrombosis within the past 3 months

Other:

  • No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No acute healing bone fracture
  • No prior uncontrolled seizures
  • No diabetic ulcers
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • At least 12 weeks since prior rituximab

Chemotherapy:

  • See Disease Characteristics
  • At least 2 weeks since prior chemotherapy and recovered

Endocrine therapy:

  • No concurrent oral steroids
  • Concurrent steroid inhaler or nasal spray allowed

Radiotherapy:

  • At least 2 weeks since prior radiotherapy

Surgery:

  • At least 4 weeks since prior major surgery except placement of venous access device

Other:

  • At least 2 weeks since other prior therapy
  • No concurrent chronic oral or parenteral anticoagulants (unless for patency of indwelling IV catheter) or anti-platelet therapy (more than 325 mg aspirin per day)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00016094
Laurence H. Baker, Southwest Oncology Group - Group Chair's Office
CDR0000068594, SWOG-S0108
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Alison T. Stopeck, MD University of Arizona
National Cancer Institute (NCI)
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP