Bevacizumab and Combination Chemotherapy in Treating Patients With Peripheral T-Cell Lymphoma or Natural Killer Cell Neoplasms
Condition: Lymphoma
MeSH terms: Lymphoma; Neoplasms
Intervention: bevacizumab; cyclophosphamide; doxorubicin; prednisone; vincristine
Intervention description: A - CHOP: 15 mg/kg IV infusion once every 21 days for 6-8 cycles. Bevacizumab is to be administered prior to CHOP therapy. Continuous bevacizumab: 15 mg/kg IV infusion once every 21 days.
Initial dose should be infused over 90 minutes. If no adverse reactions occur, the second dose should be administered over 60 minutes. Again, if no adverse reactions occur, the third and subsequent doses should be administered over 30 minutes. If infusion-related adverse reactions occur, subsequent infusions should be administered over the shortest period that is well-tolerated. Infusions should be run in via a volumetric infusion device. Do NOT administer as an IV push or bolus.; IV infusion per institutional guidelines.; Intravenously, either as a bolus injection or as a continuous infusion through a central venous line.; Prednisone is taken orally.; IV push using extravasation precautions.
Intervention MeSH terms: Prednisone; Cyclophosphamide; Bevacizumab; Doxorubicin; Liposomal doxorubicin; Vincristine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anaplastic large cell lymphoma; stage I adult T-cell leukemia/lymphoma; stage II adult T-cell leukemia/lymphoma; stage III adult T-cell leukemia/lymphoma; stage IV adult T-cell leukemia/lymphoma; peripheral T-cell lymphoma

Summary:

      RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different
      ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and
      help kill them or carry cancer-killing substances to them. Bevacizumab may also stop the
      growth of cancer cells by blocking blood flow to the cancer. Drugs used in chemotherapy work
      in different ways to stop the growth of cancer cells, either by killing the cells or by
      stopping them from dividing. Giving bevacizumab together with combination chemotherapy may
      kill more cancer cells.

      PURPOSE: This phase II trial is studying how well giving bevacizumab together with several
      chemotherapy drugs (combination chemotherapy) works in treating patients with peripheral
      T-cell lymphoma or natural killer cell neoplasms.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Diagnosis of peripheral T-cell or natural killer cell neoplasm

               -  Any stage disease allowed

               -  HTLV-positive tumors allowed

          -  At least one objective measurable disease parameter. Abnormal positron emission
             tomography scans are not considered evidence of measurable disease unless results are
             confirmed by CT scan or other appropriate imaging techniques

          -  Age 18 and over

          -  ECOG Performance status 0-2

          -  Absolute neutrophil count ≥ 1,000/mm^3(500/mm^3 if due to bone marrow involvement with
             lymphoma)

          -  Platelet count ≥ 100,000/mm^3(50,000/mm^3 if due to bone marrow involvement with
             lymphoma)

          -  Bilirubin ≤ 2.0 mg/dL (≤ 3 times upper limit of normal [ULN] if due to hepatic
             involvement with lymphoma)

          -  AST ≤ 2 times ULN (5 times ULN if due to hepatic involvement with lymphoma)

          -  PT, INR, and PTT ≤ 1.5 times normal

          -  Creatinine ≤ 2.0 mg/dL

          -  Urinary protein:creatinine ratio ≤ 1

          -  History of deep venous thrombosis allowed provided patient is on a stable dose of
             anticoagulants for at least 2 weeks prior to study entry

          -  LVEF ≥ 50%

          -  History of pulmonary embolism allowed provided patient is on a stable dose of
             anticoagulants for at least 2 weeks prior to study entry

          -  One prior cycle of CHOP for PTCL allowed

          -  More than 4 weeks since prior major invasive surgery or open biopsy

          -  At least 7 days since prior minor surgery. Peripheral lymph node core biopsy, bone
             marrow biopsy, fine needle aspiration, skin biopsy, or central line placement are not
             considered minor surgical procedures

          -  More than 7 days since prior and no concurrent anti-platelet drugs (e.g., ticlopidine,
             clopidogrel, or cilostazol) except aspirin or other nonsteroidal anti-inflammatory
             drugs

          -  Concurrent anticoagulants allowed provided patient is on a stable dose

               -  INR must be stable for at least 2 weeks prior to study entry

               -  PT/INR and/or PTT must be closely monitored and levels kept within acceptable
                  range for underlying thrombotic disease

               -  Concurrent heparin flush for maintenance of central line patency allowed

        EXCLUSION CRITERIA:

          -  Anaplastic lymphoma kinase (ALK)-positive T-cell large cell lymphoma. ALK-negative
             T-cell large cell lymphoma allowed

          -  Cutaneous T-cell lymphoma

          -  History of or current radiographic evidence of CNS metastasis, including previously
             treated, resected, or asymptomatic brain lesions or leptomeningeal involvement

          -  Evidence of bleeding diathesis or coagulopathy

          -  Cerebrovascular accident within the past 6 months

          -  Myocardial infarction within the past 6 months

          -  Unstable angina within the past 6 months

          -  New York Heart Association class II-IV congestive heart failure

          -  Uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or diastolic
             BP > 100 mm Hg)

          -  Other clinically significant cardiovascular or peripheral vascular disease

          -  Abdominal fistula within the past 6 months

          -  Gastrointestinal perforation within the past 6 months

          -  Intra-abdominal abscess within the past 6 months

          -  Concurrent major surgery

          -  Pregnant or nursing. Female patients must have negative pregnancy test. Fertile
             patients must use effective contraception

          -  History of active seizures

          -  Significant traumatic injury within the past 4 weeks

          -  Non-healing ulcer (unless involved with lymphoma)

          -  Bone fracture

          -  Active infection requiring parenteral antibiotics

          -  HIV positivity

          -  Other active malignancy within the past 6 months except carcinoma in situ of the
             cervix or basal cell carcinoma of the skin