Alemtuzumab (Campath-1H) Monoclonal Antibody in Patients With Relapsed and Resistant Classical Hodgkin's Disease

• Status: Withdrawn
• Trial end date: 2006-09-05
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

To determine the safety and efficacy of Campath-1H (Alemtuzumab) in patients with relapsed and resistant classical Hodgkin's lymphoma.

Secondary Objectives:

1. To determine the duration of response and time to progression after Campath-1H therapy in this patient population.

2. To determine the effect of Campath-1H on serum IL-6, IL-10, and IL-13 levels in patients with relapsed and resistant classical Hodgkin's lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Alemtuzumab; Antibodies; Antibodies, Monoclonal; Immunoglobulins

Criteria

Inclusion Criteria:

• Relapsed or refractory Hodgkin's disease with a minimum of 2 prior treatment regimens, including autologous bone marrow transplantation.

• Must have histologically proven diagnosis of nodular sclerosis or mixed cellularity Hodgkin's disease.

• Hodgkin's lymphoma should be limited to lymph nodes, spleen, and bone marrow.

• Must have bi-dimensionally measurable disease defined as a lymph node at least 2 cm by computed tomography (CT) scan.

• Platelet count equal to or greater than 50,000/uL; absolute neutrophil count equal to or greater than 1,000/uL.

• Must sign a consent form.

• Males or females equal to or greater than 18 years of age.

• Patients may be taking voriconazole, itraconazole, or diflucan.

Exclusion Criteria:

• No serious inter-current infections requiring therapy.

• No Hodgkin-specific therapy within the last 3 weeks.

• Pregnant women and women of childbearing potential and men of reproductive potential who are not practicing adequate contraception.

• Lymphocyte depletion or lymphocyte predominance histology.

• History of HIV infection.

• Central nervous system (CNS) involvement with lymphoma including epidural disease and cord compression.

• Prior allogeneic stem cell transplantation.

• Patients receiving steroids within 3 weeks of registration.

• Patients with a history of prior severe opportunistic infections that are controlled by T-cell immunity, such as pneumocystis pneumonia (PCP), herpes virus infections, mycobacterial disease, invasive mold infections or endemic fungi.

• Patients with an ejection fraction of less than 40%.