Galiximab in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma - Full Text View

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	Biological: galiximab	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Galiximab (Anti-CD80) for Patients With Relapsed/Refractory Hodgkin Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Hodgkin Disease Lymphoma

U.S. FDA Resources

Further study details as provided by Cancer and Leukemia Group B:

Primary Outcome Measures:

Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Survival [ Time Frame: 10 years post study entry ] [ Designated as safety issue: No ]
Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment:	30
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2018
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Galaximab Treatment of Patients with relapsed/refractory Hodgkin Lymphoma with monoclonal antibody therapy	Biological: galiximab 500 mg/sq m IV infusion over 60 min on days 1,8,15,and 22 of Mon 1; then once q 4 wks until progression

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

Show 56 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Sonali M. Smith, MD

University of Chicago

More Information

Additional Information:

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

No publications provided

Responsible Party:	Monica M. Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00516217 History of Changes
Other Study ID Numbers:	CDR0000561185, U10CA031946, CALGB-50602
Study First Received:	August 14, 2007
Last Updated:	April 6, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cancer and Leukemia Group B:

recurrent adult Hodgkin lymphoma
adult lymphocyte predominant Hodgkin lymphoma

Additional relevant MeSH terms:

Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms

Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013