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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Gemcitabine

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