Status:
COMPLETED
SGN-30 and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Lymphocyte Depletion Hodgkin Lymphoma
Adult Lymphocyte Predominant Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This randomized phase II trial studies the side effects and how well giving monoclonal antibody SGN-30 together with combination chemotherapy works in treating patients with Hodgkin lymphoma that has ...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the complete and partial response rates following treatment with the anti-cluster of differentiation (CD) 30 antibody, SGN-30 (monoclonal antibody SGN-30), and gem...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically documented CD30-positive classical Hodgkin lymphoma according to the World Health Organization (WHO) classification of lymphoid malignancies that is recurrent or refractory after at least one prior therapy
- Note: Patients with nodular lymphocyte predominant HL are not eligible; all other subtypes including nodular sclerosis, lymphocyte-depleted, lymphocyte rich, and mixed cellularity HL may be enrolled
- Core needle biopsies are acceptable if they contain adequate tissue for primary diagnosis and immunophenotyping; bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies; fine needle aspirates are not acceptable; if the original diagnostic specimen is not available, specimens obtained at relapse may be submitted; if multiple specimens are available, please submit the most recent; failure to submit pathology specimens within 60 days of patient registration will be considered a major protocol violation
- Patients must have relapsed or refractory disease after at least one prior therapy, with at least a 3 week interval from the completion of the most recent chemotherapy or radiotherapy regimen; recovery to =\< grade 1 from all toxicities related to the prior treatments is required; patients who have previously received a stem cell transplant are permitted to enroll on this study
- Prior treatment with an anti-CD30 antibody, gemcitabine, vinorelbine, or pegylated liposomal doxorubicin is not permitted
- No uncontrolled angina, no myocardial infarction (MI) within 6 months of study entry, and no New York Heart Association (NYHA) class II or greater congestive heart failure (CHF)
- Baseline left ventricular ejection fraction (LVEF) by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) must be \>= 45%
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Measurable disease must be present on either physical examination or imaging studies; evaluable or non-measurable disease alone is not acceptable
- Measurable disease is defined as any lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 10 mm
- Non-measurable disease includes all other lesions, including small lesions (\< 10 mm) and truly non-measurable lesions
- Lesions that are considered non-measurable include the following:
- Bone lesions (lesions, if present, should be noted)
- Bone marrow involvement (if present, this should be noted)
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Pregnant or nursing women may not be enrolled; women of childbearing potential must have a negative serum or urine pregnancy test prior to registration; women and men of reproductive potential should agree to use an effective means of birth control
- Corrected diffusion capacity of carbon monoxide (DLCO) \>= 50%
- Absolute neutrophil count (ANC) \>= 1,200/uL
- Platelet count \>= 100,000/uL
- Creatinine =\< 2.0 mg/dL
- Bilirubin =\< 2.0 mg/dL
- Absent a history of Gilbert's disease
- Aspartate aminotransferase (AST) =\< 2.0 x upper limits of normal
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00337194
Start Date
April 1 2006
End Date
October 1 2014
Last Update
February 23 2015
Active Locations (1)
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1
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606