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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00516217
• Other study ID #: CALGB-50602
• Secondary ID: U10CA031946CALGB
• Status: Completed
• Phase: Phase 2
• First received: August 14, 2007
• Last updated: July 1, 2016
• Start date: June 2008
• Est. completion date: February 2015

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2015
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma

Intervention

Biological:
• galiximab

Locations

Country	Name	City	State
United States	Randolph Hospital	Asheboro	North Carolina
United States	CancerCare of Maine at Eastern Maine Medical Center	Bangor	Maine
United States	St. Joseph Medical Center	Bloomington	Illinois
United States	Graham Hospital	Canton	Illinois
United States	Memorial Hospital	Carthage	Illinois
United States	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio
United States	Danville Regional Medical Center	Danville	Virginia
United States	Elkhart General Hospital	Elkhart	Indiana
United States	Union Hospital Cancer Program at Union Hospital	Elkton MD	Maryland
United States	Eureka Community Hospital	Eureka	Illinois
United States	Galesburg Clinic, PC	Galesburg	Illinois
United States	Galesburg Cottage Hospital	Galesburg	Illinois
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Moses Cone Regional Cancer Center at Wesley Long Community Hospital	Greensboro	North Carolina
United States	Mason District Hospital	Havana	Illinois
United States	Hopedale Medical Complex	Hopedale	Illinois
United States	Kinston Medical Specialists	Kinston	North Carolina
United States	Howard Community Hospital	Kokomo	Indiana
United States	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana
United States	Tunnell Cancer Center at Beebe Medical Center	Lewes	Delaware
United States	Cancer Resource Center - Lincoln	Lincoln	Nebraska
United States	McDonough District Hospital	Macomb	Illinois
United States	Mount Sinai Medical Center	New York	New York
United States	New York Weill Cornell Cancer Center at Cornell University	New York	New York
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	BroMenn Regional Medical Center	Normal	Illinois
United States	Community Cancer Center	Normal	Illinois
United States	Alegant Health Cancer Center at Bergan Mercy Medical Center	Omaha	Nebraska
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Immanuel Medical Center	Omaha	Nebraska
United States	Community Hospital of Ottawa	Ottawa	Illinois
United States	Oncology Hematology Associates of Central Illinois, PC - Ottawa	Ottawa	Illinois
United States	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Oncology Hematology Associates of Central Illinois, PC - Peoria	Peoria	Illinois
United States	OSF St. Francis Medical Center	Peoria	Illinois
United States	Proctor Hospital	Peoria	Illinois
United States	Illinois Valley Community Hospital	Peru	Illinois
United States	Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Perry Memorial Hospital	Princeton	Illinois
United States	Annie Penn Cancer Center	Reidsville	North Carolina
United States	Virginia Commonwealth University Massey Cancer Center	Richmond	Virginia
United States	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	Saint Joseph Regional Medical Center	South Bend	Indiana
United States	South Bend Clinic	South Bend	Indiana
United States	St. Margaret's Hospital	Spring Valley	Illinois
United States	Lakeland Regional Cancer Care Center - St. Joseph	St. Joseph	Michigan
United States	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey
United States	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington	District of Columbia
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response	Overall response is defined as achievement of a complete response (CR) or partial response (PR) as defined by the Revised Response Criteria for Malignant Lymphoma.; CR: complete disappearance of all detectable disease PR: >=50% decrease in the sum of the product of diameters of indicator lesions.	Duration of treatment (up to 10 years)	No
Secondary	12 Month Overall Survival Rate	Percentage of patients who were alive at 12 months. The 12-month survival rate was estimated using the Kaplan Meier method.	12 months	No
Secondary	6 Month Progression Free Survival Rate	Percentage of patients who were progression free at 6 months. The 6-month progression free rate was estimated using the Kaplan Meier method.; Relapse was assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Progression required a appearance of any new lesion > 1.5 cm, at least 50% increase from nadir in the sum of products of involved nodes, or a 50% increase in the longest diameter of any single node.	6 months	No