Clinical trial NCT00284804: A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease
Official title: An Open-label, Randomized, Multicenter, Phase II Study of MDX-060 in Combination With Gemcitabine, MDX060 in Combination With Dexamethasone, and Gemcitabine Monotherapy in Patients With Relapsed or Refractory Hodgkin's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hodgkin's Disease
Keywords: relapsed or refractory Hodgkin's Disease
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-02-01
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to determine the objective response rate in patients with relapsed or refractory Hodgkin's disease treated with MDX-060 in combination with gemcitabine or gemcitabine alone.

Detailed description: Secondary objectives include:

* to characterize progression-free survival
* to characterize time to progression
* to determine response duration
* to characterize the effect of study drug on health-related quality of life
* to explore the correlation of positron emission tomography (PET) scan results with objective responses observed with conventional imaging in this patient population
* to characterize the immunogenicity response of MDX-060
* to characterize the safety of MDX-060, and
* to characterize the pharmacokinetic profile of MDX-060

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Hodgkin's disease \[HD\] (excluding HIV-associated HD)
* Patients must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained
* Patients must have failed or relapsed following second line (i.e., salvage) chemotherapy or relapsed or failed following autologous stem cell transplant
* ECOG Performance Status of 0-2
* Patients must have bi-measurable disease
* At least 4 weeks since the last chemotherapy or radiation therapy with clinical evidence of recovery from any toxicity associated with such treatment
* Life expectancy 12 weeks or greater
* Screening laboratory values must be met
* Patients on corticosteroids must be tapered off the medication 2 weeks prior to study drug administration and remain off corticosteroids until study completion.

Exclusion Criteria:

* Previous treatment with any anti-CD30 antibody
* History of allogeneic transplant
* Any tumor lesion 10cm or greater in diameter
* Any other malignancy, excluding basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Any cancer from which the patient has been disease free for at least 5 years is permissible.
* Any significant active or chronic infection
* Apparent active or latent tuberculosis (TB) infection
* Patients who are pregnant or nursing
* Any underlying medical condition which, in the investigator's opinion, will make the administration of the study drug hazardous or obscure the interpretation of adverse events
* Concomitant chemotherapy, steroids, investigational agents, other anti-HD biologics, or radiation therapy

Primary outcomes:
measure: Overall response rate
timeFrame: Day 50/57
Secondary outcomes:
measure: Progression-free survival
timeFrame: Day 50/57
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope, National Medical Center
state: California
city: Fresno
country: United States
facility: California Oncology of the Central Valley
state: California
city: LaJolla
country: United States
facility: University of California, San Diego/Moores UCSD Cancer Center
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer & Research Institute
state: Florida
city: Chicago
country: United States
facility: Rush Cancer Institute
state: Illinois
city: Beech Grove
country: United States
facility: St. Francis Hospital Center
state: Indiana
city: Indianapolis
country: United States
facility: American Health Network of Indiana
state: Indiana
city: Boston
country: United States
facility: Division of Hematology/Oncology, Tufts-New England Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Las Vegas
country: United States
facility: Nevada Cancer Institute
state: Nevada
city: New Brunswick
country: United States
facility: The Cancer Institute of New Jersey
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Center
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Huntersville
country: United States
facility: Carolina BioOncology Institute, PLLC
state: North Carolina
city: Houston
country: United States
facility: M.D. Anderson Cancer Center, The University of Texas
state: Texas
city: Morgantown
country: United States
facility: Mary Babb Randolph Cancer Center
state: West Virginia
Study officials:
affiliation: Medarex
name: Medarex Medical Monitor
role: STUDY_DIRECTOR
References: