Brentuximab is an antibody-drug conjugate (ADC), which is the combination of an antibody (a protein that binds to cells) and a chemotherapy molecule. Brentuximab works by using the antibody portion to enter into the Hodgkin lymphoma cells and then releasing the chemotherapy portion, which attempts to destroy the cell. The intravenous chemotherapy drugs Adriamycin, Vinblastine and Dacarbazine (AVD) which you will receive in this research study are approved for use in people with Hodgkin Lymphoma. A drug called bleomycin is usually included with AVD, but since it appears to be a less effective drug with significant potential risks, it is being replaced in this study with the drug brentuximab. In this research study, the investigators are looking to see whether brentuximab in combination with AVD is effective in treating limited-stage Hodgkin Lymphoma.
Each treatment cycle is 28 days. You will receive brentuximab alone on Day 1 and 15 of the first cycle (lead-in cycle). After cycle 1, you will receive brentuximab combined with AVD on Day 1 and 15 for 4-6 cycles, depending on your response to therapy. Brentuximab and AVD will be given to you by intravenous infusion (IV). The following test and procedures will be performed on Days 1 and 15 of each cycle: * Review of any side effects you have experienced and all medications you are taking * Performance Status * Physical exam and vital signs * Routine blood tests * Questionnaire to evaluate symptoms of neuropathy * Research blood sample to look at markers to see how your body is responding to study medication * PET-CT scan prior to completing cycle 2 of combination brentuximab/AVD After the final dose of the study drug: The following assessments will be performed within one month of your last dose of study medication: * Review of any side effects you have experienced and all medications you are taking * Performance Status * Physical exam and vital signs * Routine blood tests * Questionnaire to evaluate symptoms of neuropathy * Research blood sample to look at markers to see how your body is responding to study medication * PET-CT scan Follow up will include the following * Review of any side effects you have experienced and all medications you are taking * Performance Status * Review and Physical exam * Routine blood tests * Questionnaire to evaluate symptoms of neuropathy * CT scans
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg
Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine
Moffitt Cancer Center
Tampa, Florida, United States
Massachusetts General Hosptial
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Complete Response Rate
Complete response rate at the end of therapy as measured by Positron emission tomography-computed tomography (PET/CT). Response is evaluated using Revised International Working Group Criteria. Complete response is defined as disappearance of all evidence of disease.
Time frame: End of Therapy (median duration of four months)
Overall Response Rate After One Cycle of Brentuximab
The number of participants achieving a Partial Response (PR) or Complete Response (CR) after one cycle of Brentuximab monotherapy as measured via PET/CT response. Response is evaluated using the Revised International Working Group Criteria. * CR: Disappearance of all evidence of disease * PR: Regression of measurable disease and no new sites
Time frame: 28 days
Overall Response Rate
The number of participants achieving a Partial Response (PR) or Complete Response (CR) at the end of therapy as measured via PET/CT response. Response is evaluated using the Revised International Working Group Criteria. * CR: Disappearance of all evidence of disease * PR: Regression of measurable disease and no new sites
Time frame: End of Therapy (median duration of four months)
Grade III or IV Adverse Events
A summary of the grade 3 or 4 adverse events experienced by participants as determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The data is shown as the number of participants that experienced at least one grade 3 or 4 adverse event for each of the specified toxicities.
Time frame: 2 years
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