Status:
COMPLETED
Brentuximab Vedotin, Ifosfamide, Carboplatin, and Etoposide in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Seagen Inc.
Conditions:
Recurrent Hodgkin Lymphoma
Refractory Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase I/II trial studies the side effects and best dose of brentuximab vedotin that can be combined with ifosfamide, carboplatin, and etoposide in treating patients with Hodgkin lymphoma that has...
Detailed Description
PRIMARY OBJECTIVES: I. To determine maximally tolerated dose of brentuximab vedotin that can be combined with ifosfamide, carboplatin and etoposide chemotherapy in patients with relapsed or refractor...
Eligibility Criteria
Inclusion
- Patients must have primary refractory or first relapse of cluster of differentiation 30 (CD30)+ Hodgkin lymphoma
- Patients must have measurable disease defined as lesions that can be accurately measured in two dimensions by computed tomography (CT), magnetic resonance imaging (MRI), medical photograph (skin or oral lesion), plain x-ray, or other conventional technique and a greatest transverse diameter of 1 cm or greater; or palpable lesions with both diameters \>= 2 cm; further, at least 1 of these lesions must be positive by positron emission tomography (PET) scan (i.e., Deauville score of 4 or more); Note: CT scans remain the standard for evaluation of nodal disease
- Patients must have a CT of chest, abdomen, and pelvis with PET within 28 days of enrollment; patients with evidence of lymphadenopathy in the neck must have a dedicated CT of neck
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (performance status of 2 will be allowed if poor performance status is thought to be directly secondary to patient's Hodgkin lymphoma \[HL\])
- Absolute neutrophil count (ANC) \>= 1,500/uL, performed within 28 days prior to registration
- Platelets \>= 100,000/uL (without transfusion or growth factor support), performed within 28 days prior to registration
- Serum creatinine \< 1.5 mg/dl or creatinine clearance (CrCl) \> 60 mL/min, performed within 28 days prior to registration
- Total bilirubin \< 2 times upper limit of normal (unless due to Gilbert's syndrome), performed within 28 days prior to registration
- Aspartate aminotransferase (AST) \< 2.5 times upper limit of normal, performed within 28 days prior to registration
- All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
- Patients must be anticipated to complete 2 cycles of chemotherapy
Exclusion
- Patients known to be positive for human immunodeficiency virus (HIV)
- Pregnant or nursing women; men or women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
- Patients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, breast or cervical cancer in situ, or other cancer from which the patient has been disease-free for 5 years or greater, unless approved by the protocol chair or co-chair
- Patients with known allergy, intolerance, or resistance (i.e., remission duration less than 6 months or lack of response) to ifosfamide, carboplatin, or etoposide
- Patients with evidence of active central nervous system lymphoma
- Patients with prior receipt of brentuximab vedotin
- Patients with peripheral neuropathy of \> grade 1
- Patients who have other medical conditions that would contraindicate treatment with aggressive chemotherapy (including active infection, uncontrolled hypertension, congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, or uncontrolled arrhythmia); if the patient's cardiac history is questionable, a measurement of left ventricular ejection fraction should be obtained within 42 days prior to registration; patients with left ventricular ejection fraction \< 50% are not eligible
- Prior failed (\< 5 x 10\^6 CD34/kg) peripheral blood stem cell (PBSC) collection
- Patients who had pelvic radiation within 12 months
- Previous chemotherapy/immunotherapy within 3 weeks before study entry
- Concurrent use of other anti-cancer agents or experimental treatments
Key Trial Info
Start Date :
October 10 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02227199
Start Date
October 10 2014
End Date
July 28 2025
Last Update
November 18 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109