Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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.

Eligibility 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

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)

Trial Contact Information

Trial Lead Organizations/Sponsors

Southwest Oncology Group

Alison T. Stopeck

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00016094
Information obtained from ClinicalTrials.gov on January 12, 2012

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