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Bevacizumab and Combination C...

Bevacizumab and Combination Chemotherapy in Treating Patients With Peripheral T-Cell Lymphoma or Natural Killer Cell Neoplasms

Last Updated: 2023-06-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-14

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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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 comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP).

Secondary

* Determine the overall response rate (complete remission \[CR, unconfirmed CR, or functional CR\] and partial remission) in these patients after courses 3, 6, and 8 of this treatment regimen.
* Determine the overall survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive 6-8 cycles of A-CHOP followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 \[max. 2 mg\]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.

After completion of study treatment, patients are followed every 3 months for 2 years, and then every 6 months for up to 5 years.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study within 22 months.

ACTUAL ACCRUAL: 46

Conditions

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Lymphoma

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (A-CHOP followed by MA)

Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 \[max. 2 mg\]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.

Group Type EXPERIMENTAL

bevacizumab

Intervention Type BIOLOGICAL

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.

cyclophosphamide

Intervention Type DRUG

IV infusion per institutional guidelines.

doxorubicin

Intervention Type DRUG

Intravenously, either as a bolus injection or as a continuous infusion through a central venous line.

prednisone

Intervention Type DRUG

Prednisone is taken orally.

vincristine

Intervention Type DRUG

IV push using extravasation precautions.

Interventions

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bevacizumab

Intervention Type BIOLOGICAL

cyclophosphamide

IV infusion per institutional guidelines.

Intervention Type DRUG

doxorubicin

Intravenously, either as a bolus injection or as a continuous infusion through a central venous line.

Intervention Type DRUG

prednisone

Prednisone is taken orally.

Intervention Type DRUG

vincristine

IV push using extravasation precautions.

Intervention Type DRUG

Other Intervention Names

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NSC 704865, RhuMAb VEGF, Recombinant Humanized Monoclonal Anti-VEGF Antibody. Cytoxan, Neosar, CTX, CPM. Adriamycin, Rubex, Adriamycin RDF, Adriamycin PFS, hydroxydaunorubicin, hydroxydaunomycin, ADR. Deltasone, Orasone, Medicorten, Panasol-S, Liquid-Pred. Oncovin, Vincasar PFS vincristine sulfate, VCR, leucocristine, LCR.

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristen N. Ganjoo, MD

Role: STUDY_CHAIR

Veterans Affairs Medical Center - Palo Alto

Locations

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California Cancer Care, Incorporated - Greenbrae

Greenbrae, California, United States

Site Status

Veterans Affairs Medical Center - Palo Alto

Palo Alto, California, United States

Site Status

Front Range Cancer Specialists

Fort Collins, Colorado, United States

Site Status

Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status

St. Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital

Canton, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

Site Status

Hematology and Oncology Associates

Chicago, Illinois, United States

Site Status

Eureka Community Hospital

Eureka, Illinois, United States

Site Status

Galesburg Clinic, PC

Galesburg, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Hopedale Medical Complex

Hopedale, Illinois, United States

Site Status

Midwest Center for Hematology/Oncology

Joliet, Illinois, United States

Site Status

North Shore Oncology and Hematology Associates, Limited - Libertyville

Libertyville, Illinois, United States

Site Status

McDonough District Hospital

Macomb, Illinois, United States

Site Status

La Grange Oncology Associates - Geneva

Naperville, Illinois, United States

Site Status

Cancer Care and Hematology Specialists of Chicagoland - Niles

Niles, Illinois, United States

Site Status

BroMenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center

Normal, Illinois, United States

Site Status

Community Hospital of Ottawa

Ottawa, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, United States

Site Status

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

OSF St. Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois Valley Community Hospital

Peru, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

Swedish-American Regional Cancer Center

Rockford, Illinois, United States

Site Status

Hematology Oncology Associates - Skokie

Skokie, Illinois, United States

Site Status

St. Margaret's Hospital

Spring Valley, Illinois, United States

Site Status

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Site Status

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Site Status

Saint Anthony Memorial Health Centers

Michigan City, Indiana, United States

Site Status