Galiximab in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring recurrent adult Hodgkin lymphoma, adult lymphocyte predominant Hodgkin 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
Sites / Locations
- Tunnell Cancer Center at Beebe Medical Center
- CCOP - Christiana Care Health Services
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
- St. Joseph Medical Center
- Graham Hospital
- Memorial Hospital
- University of Chicago Cancer Research Center
- Eureka Community Hospital
- Galesburg Clinic, PC
- Galesburg Cottage Hospital
- Mason District Hospital
- Hopedale Medical Complex
- McDonough District Hospital
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- OSF St. Francis Medical Center
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- St. Margaret's Hospital
- Elkhart General Hospital
- Howard Community Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Saint Joseph Regional Medical Center
- South Bend Clinic
- CancerCare of Maine at Eastern Maine Medical Center
- Union Hospital Cancer Program at Union Hospital
- Lakeland Regional Cancer Care Center - St. Joseph
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
- Cancer Resource Center - Lincoln
- CCOP - Missouri Valley Cancer Consortium
- Immanuel Medical Center
- Alegant Health Cancer Center at Bergan Mercy Medical Center
- Creighton University Medical Center
- Cancer Institute of New Jersey at Cooper - Voorhees
- New York Weill Cornell Cancer Center at Cornell University
- Mount Sinai Medical Center
- Randolph Hospital
- Presbyterian Cancer Center at Presbyterian Hospital
- Wayne Memorial Hospital, Incorporated
- Moses Cone Regional Cancer Center at Wesley Long Community Hospital
- Kinston Medical Specialists
- Annie Penn Cancer Center
- Wake Forest University Comprehensive Cancer Center
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
- Danville Regional Medical Center
- Virginia Commonwealth University Massey Cancer Center
Arms of the Study
Arm 1
Experimental
Galaximab
Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity