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LymphomaPhase 2NCT00516217

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

A Phase 2 study testing galiximab in people with Lymphoma, run by Alliance for Clinical Trials in Oncology at 56 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Lymphoma
What is being tested?
galiximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
56 sitesUnited States
Study dates
Jun 2008to Feb 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

56 sites in 1 country.

56 sites in 1 country

United States56 sites

  • Randolph Hospital

    Asheboro, North Carolina, 27203-5400

  • CancerCare of Maine at Eastern Maine Medical Center

    Bangor, Maine, 04401

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Graham Hospital

    Canton, Illinois, 61520

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Columbus, Ohio, 43210-1240

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital Cancer Program at Union Hospital

    Elkton MD, Maryland, 21921

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • Galesburg Clinic, PC

    Galesburg, Illinois, 61401

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Greensboro, North Carolina, 27403-1198

  • Mason District Hospital

    Havana, Illinois, 62644

  • Hopedale Medical Complex

    Hopedale, Illinois, 61747

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Howard Community Hospital

    Kokomo, Indiana, 46904

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, 19958

  • Cancer Resource Center - Lincoln

    Lincoln, Nebraska, 68510

  • McDonough District Hospital

    Macomb, Illinois, 61455

  • New York Weill Cornell Cancer Center at Cornell University

    New York, New York, 10021

  • Mount Sinai Medical Center

    New York, New York, 10029

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Alegant Health Cancer Center at Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Creighton University Medical Center

    Omaha, Nebraska, 68131-2197

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350

  • Oncology Hematology Associates of Central Illinois, PC - Ottawa

    Ottawa, Illinois, 61350

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • Proctor Hospital

    Peoria, Illinois, 61614

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224-1791

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Annie Penn Cancer Center

    Reidsville, North Carolina, 27320

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Lakeland Regional Cancer Care Center - St. Joseph

    Saint Joseph, Michigan, 49085

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Saint Joseph Regional Medical Center

    South Bend, Indiana, 46617

  • South Bend Clinic

    South Bend, Indiana, 46617

  • St. Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    St Louis, Missouri, 63110

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1096

Other trials in United States

About this study

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

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.

Read the detailed 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.

Conditions
Lymphoma
Being tested
galiximab
Keywords
recurrent adult Hodgkin lymphoma, adult lymphocyte predominant Hodgkin lymphoma
Medical subject headings
Lymphoma, Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • galiximabBiological

Study groups in NCT00516217
Study groupRoleWhat they receive
GalaximabExperimentalInduction: 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
Receives: Biological: galiximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Duration of treatment (up to 10 years)

Secondary outcomes (2)

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2007 (estimated)
  2. Study startJun 2008
  3. Primary completionSep 2011
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00516217
Sponsor's protocol ID
CALGB-50602
Other IDs
U10CA031946, CALGB-50602, CDR0000561185
Status last verified
Jul 2016
First submitted
14 Aug 2007
Last updated
6 Jul 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing galiximab in people with Lymphoma, run by Alliance for Clinical Trials in Oncology at 56 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response (time frame: Duration of treatment (up to 10 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00516217.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.

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