Phase 2
N=29
Galiximab in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00516217 ↗Enrolled (actual)
29
Serious AEs
27.6%
Results posted
Feb 2015
Primary outcome: Primary: Overall Response — 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- galiximab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response |
3 | — |
| SECONDARY 12 Month Overall Survival Rate |
79 | — |
| SECONDARY 6 Month Progression Free Survival Rate |
21 | — |
Summary
RATIONALE: Monoclonal antibodies, such as galiximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.
PURPOSE: This phase II trial is studying how well galiximab works in treating patients with relapsed or refractory Hodgkin's lymphoma.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed classical Hodgkin lymphoma (HL):
- 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
- Recurrent or refractory disease after at least two prior standard chemotherapy regimens
- Nodular lymphocyte predominant HL allowed
- Measurable disease must be present on either physical examination or imaging studies
- 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
- Evaluable or non-measurable disease alone is not acceptable including any of 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
- Ineligible for a stem cell transplantation
- Patients eligible for CALGB-50502 should not be considered for this study
- No known CNS involvement
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC ≥ 500/μL
- Platelet count ≥ 50,000/μL
- Creatinine ≤ 2.0 mg/dL
- Total bilirubin ≤ 2.0 mg/dL (no history of Gilbert Disease)
- AST ≤ 2.5 times upper limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study
- No known HIV infection
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered to ≤ grade 1 from all toxicities related to prior treatments
- At least 4 weeks since prior chemotherapy, radiotherapy, or biologic anticancer therapy
- Prior autologous and/or allogeneic stem cell transplantation allowed
- No prior anti-CD80 antibody
- No concurrent steroids, hormones, or other chemotherapeutic agents except for steroids given for adrenal failure and hormones administered for non-disease-related conditions (e.g., insulin for diabetes)
- The use of dexamethasone and other steroidal antiemetics is prohibited unless to treat acute grade 3 or 4 monoclonal antibody-associated infusion reactions not responsive to transient discontinuation of antibody infusion or acetaminophen and diphenhydramine
- Dexamethasone is also allowed for re-treatment after an infusion reaction
Data sourced from ClinicalTrials.gov (NCT00516217). 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.