Phase 2
N=30
SGN-30 and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
Adult Lymphocyte Depletion Hodgkin Lymphoma · Adult Lymphocyte Predominant Hodgkin Lymphoma · Adult Mixed Cellularity Hodgkin Lymphoma · Adult Nodular Sclerosis Hodgkin Lymphoma · Recurrent Adult Hodgkin Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00337194 ↗Enrolled (actual)
30
Serious AEs
33.3%
Results posted
Feb 2015
Primary outcome: Primary: Number of Participants With Overall Response (OR) — 15; 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- monoclonal antibody SGN-30 (Biological); placebo (Other); vinorelbine tartrate (Drug); pegylated liposomal doxorubicin hydrochloride (Drug); gemcitabine hydrochloride (Drug); laboratory biomarker analysis (Other); pharmacological study (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Overall Response (OR) |
15; 4 | — |
| SECONDARY Event Free Survival (EFS) |
11.3; 4.1 | — |
| SECONDARY Overall Survival (OS) At 1 Year |
86; 30 | — |
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 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.
Eligibility Criteria
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 = = 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 ( = 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
Data sourced from ClinicalTrials.gov (NCT00337194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.