SGN-30 and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

Completed · Phase 2 · Has a placebo group

Conditions studied: Adult Lymphocyte Depletion Hodgkin Lymphoma, Adult Lymphocyte Predominant Hodgkin Lymphoma, Adult Mixed Cellularity Hodgkin Lymphoma, Adult Nodular Sclerosis Hodgkin Lymphoma, Recurrent Adult Hodgkin Lymphoma

In brief

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 returned after a period of improvement or did not respond to previous treatment. Monoclonal antibodies, such as SGN-30, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as gemcitabine hydrochloride, vinorelbine tartrate, and pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody SGN-30 together with combination chemotherapy may kill more cancer cells and shrink tumors.

Key facts

Study ID

NCT00337194

Run by

National Cancer Institute (NCI)

People needed

30

Starts

2006-04-01

Expected to finish

2014-10-01

Last updated by the study team

2015-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Cancer and Leukemia Group B — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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