A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 2

Conditions

Hodgkin's Disease

Treatments

Drug: MDX-060

Study type

Interventional

Funder types

Industry

Identifiers

NCT00284804

MDX060-05/05E

Details and patient eligibility

About

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.

Full 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

Enrollment

74 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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