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A Phase II Study of Galiximab (Anti-CD80) for Patients With Relapsed/Refractory Hodgkin Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

A Phase II Study of Galiximab (Anti-CD80) for Patients With Relapsed/Refractory Hodgkin Lymphoma


OBJECTIVES:

Primary

- To determine the response rate (complete and overall response) in patients with
relapsed or refractory Hodgkin lymphoma (HL) treated with galiximab.

Secondary

- To assess the duration of response, progression-free survival, and overall survival of
patients with relapsed or refractory HL.

- To assess the safety and tolerability of galiximab in patients with relapsed or
refractory HL.

- To determine if FDG-PET correlates with outcome in patients with relapsed or refractory
HL treated with galiximab.

OUTLINE: This is a multicenter study.

- Induction therapy: Patients receive galiximab IV over 60 minutes on days 1, 8, 15, and
22 in month 1.

- Extended induction therapy: Patients receive galiximab IV over 60 minutes once every
four weeks in the absence of disease progression or unacceptable toxicity.

Patients also undergo FDG-PET/CT imaging at baseline and at time of first restaging (within
7 days prior to week 8 treatment).

After completion of study treatment, patients are followed periodically for 10 years.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Sonali M. Smith, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000561185

NCT ID:

NCT00516217

Start Date:

June 2008

Completion Date:

December 2018

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • adult lymphocyte predominant Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Mount Sinai Medical CenterNew York, New York  10029
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
CancerCare of Maine at Eastern Maine Medical CenterBangor, Maine  04401
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
South Bend ClinicSouth Bend, Indiana  46617
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Immanuel Medical CenterOmaha, Nebraska  68122
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Danville Regional Medical CenterDanville, Virginia  24541
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Randolph HospitalAsheboro, North Carolina  27203
Moses Cone Regional Cancer Center at Wesley Long Community HospitalGreensboro, North Carolina  27401
Annie Penn Cancer CenterReidsville, North Carolina  27320
Western Pennsylvania Cancer Institute at Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224-1791
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921
Alegant Health Cancer Center at Bergan Mercy Medical CenterOmaha, Nebraska  68124
Kinston Medical SpecialistsKinston, North Carolina  28501
Galesburg Clinic, PCGalesburg, Illinois  61401