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Galiximab in Treating Patient...

Galiximab in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

Last Updated: 2016-07-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2015-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lymphoma

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

galiximab

Intervention Type BIOLOGICAL

Interventions

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galiximab

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sonali Smith, MD

Role: STUDY_CHAIR

University of Chicago

Locations

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Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, United States

Site Status

CCOP - Christiana Care Health Services

Newark, Delaware, United States

Site Status

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

St. Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital

Canton, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Site Status

Eureka Community Hospital

Eureka, Illinois, United States

Site Status

Galesburg Clinic, PC

Galesburg, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Hopedale Medical Complex

Hopedale, Illinois, United States

Site Status

McDonough District Hospital

Macomb, Illinois, United States

Site Status

BroMenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center

Normal, Illinois, United States

Site Status

Community Hospital of Ottawa

Ottawa, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, United States

Site Status