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

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2008

Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00516217
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: fludeoxyglucose F 18
Drug: galiximab
Phase II

MedlinePlus related topics:   Cancer    Hodgkin's Disease    Lymphoma   

ChemIDplus related topics:   Fluorodeoxyglucose F18    Galiximab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   A Phase II Study of Galiximab (Anti-CD80) for Patients With Relapsed/Refractory Hodgkin Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Complete response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Safety and tolerability [ Designated as safety issue: Yes ]

Estimated Enrollment:   56
Study Start Date:   June 2008
Estimated Primary Completion Date:   November 2008 (Final data collection date for primary outcome measure)

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516217

Locations
United States, Delaware
CCOP - Christiana Care Health Services     Recruiting
      Newark, Delaware, United States, 19713
      Contact: Clinical Trial Office - CCOP - Christiana Care Health Services     302-733-6227        
Tunnell Cancer Center at Beebe Medical Center     Recruiting
      Lewes, Delaware, United States, 19958
      Contact: Clinical Trials Office - Tunnell Cancer Center     302-645-3171        
United States, Illinois
University of Chicago Cancer Research Center     Recruiting
      Chicago, Illinois, United States, 60637-1470
      Contact: Clinical Trials Office - University of Chicago Cancer Research     773-834-7424        
United States, Maryland
Union Hospital Cancer Program at Union Hospital     Recruiting
      Elkton MD, Maryland, United States, 21921
      Contact: Stephen S. Grubbs, MD     410-398-4000        
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis     Recruiting
      Saint Louis, Missouri, United States, 63110
      Contact: Nancy L. Bartlett, MD     314-362-4843        
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees     Recruiting
      Voorhees, New Jersey, United States, 08043
      Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo     856-325-6757        
United States, North Carolina
Kinston Medical Specialists     Recruiting
      Kinston, North Carolina, United States, 28501
      Contact: Peter R. Watson, MD     252-559-2200 ext. 201        
Wayne Memorial Hospital, Incorporated     Recruiting
      Goldsboro, North Carolina, United States, 27534
      Contact: James N. Atkins, MD     919-580-0000        
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center     Recruiting
      Columbus, Ohio, United States, 43210-1240
      Contact: Clinical Trials Office - OSU Comprehensive Cancer Center     614-293-4976     osu@emergingmed.com    
United States, Pennsylvania
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital     Recruiting
      Pittsburgh, Pennsylvania, United States, 15224-1791
      Contact: John Lister     412-578-5000        
United States, Virginia
Danville Regional Medical Center     Recruiting
      Danville, Virginia, United States, 24541
      Contact: Clinical Trials Office - Danville Regional Medical Center     434-799-3753        
Virginia Commonwealth University Massey Cancer Center     Recruiting
      Richmond, Virginia, United States, 23298-0037
      Contact: Clinical Trials Office -Virginia Commonwealth University Masse     804-628-1939        

Sponsors and Collaborators
Cancer and Leukemia Group B
National Cancer Institute (NCI)

Investigators
Study Chair:     Sonali M. Smith, MD     University of Chicago    
Investigator:     Nancy L. Bartlett, MD     Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000561185, CALGB-50602
First Received:   August 14, 2007
Last Updated:   October 3, 2008
ClinicalTrials.gov Identifier:   NCT00516217
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent adult Hodgkin lymphoma  
adult lymphocyte predominant Hodgkin lymphoma  

Study placed in the following topic categories:
Lymphatic Diseases
Hodgkin's disease
Immunoproliferative Disorders
Hodgkin lymphoma, adult
Lymphoproliferative Disorders
Hodgkin Disease
Lymphoma
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on October 07, 2008




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