Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Bevacizumab in Treating Patients With Non-Hodgkin's Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Over 18	NCI	SWOG-S0108 S0108, NCT00016094

Objectives

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

Entry Criteria

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

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)

Patient Characteristics:

Age:

• Over 18

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 500/mm³
• Platelet count at least 75,000/mm³
• 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

Expected Enrollment

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

Outcomes

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

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.

Stopeck AT, Unger JM, Rimsza LM, et al.: A phase II trial of single agent bevacizumab in patients with relapsed, aggressive non-Hodgkin lymphoma: Southwest oncology group study S0108. Leuk Lymphoma 50 (5): 728-35, 2009.[PUBMED Abstract]

Stopeck AT, Bellamy W, Unger J, et al.: Phase II trial of single agent bevacizumab (Avastin) in patients with relapsed, aggressive non-Hodgkin's lymphoma (NHL): Southwest Oncology Group study S0108. [Abstract] J Clin Oncol 23 (Suppl 16): A-6592, 583s, 2005.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Alison Stopeck, MD, Protocol chair		Ph: 520-626-2816; 800-622-2673 Email: astopeck@azcc.arizona.edu

Registry Information
Official Title		Bevacizumab (rhuMAb VEGF) Therapy For Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma
Trial Start Date		2001-04-15
Trial Completion Date		2008-09-01
Registered in ClinicalTrials.gov		NCT00016094
Date Submitted to PDQ		2001-03-12
Information Last Verified		2009-01-12
NCI Grant/Contract Number		CA32102

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