Status:
COMPLETED
Bevacizumab and Combination Chemotherapy in Treating Patients With Peripheral T-Cell Lymphoma or Natural Killer Cell Neoplasms
Lead Sponsor:
Eastern Cooperative Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
OBJECTIVES: Primary * Determine the 12-month progression-free survival of patients with peripheral T-cell or natural killer cell neoplasms treated with bevacizumab and combination chemotherapy compr...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 14 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00217425
Start Date
September 14 2006
End Date
March 1 2014
Last Update
June 18 2023
Active Locations (110)
Enter a location and click search to find clinical trials sorted by distance.
1
California Cancer Care, Incorporated - Greenbrae
Greenbrae, California, United States, 94904
2
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, United States, 94304
3
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
4
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60504