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Study of Alemtuzumab (Campath-1H) Monoclonal Antibody in Patients With Relapsed and Resistant Classical Hodgkin's Disease
This study has been completed.
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00129753
  Purpose

This is a phase II study of alemtuzumab (Campath-1H) monoclonal antibody in patients with relapsed and resistant classical Hodgkin's disease.


Condition Intervention Phase
Hodgkin's Disease
Drug: Alemtuzumab (Campath-1H) Monoclonal Antibody
Phase II

MedlinePlus related topics: Cancer Hodgkin's Disease
Drug Information available for: Alemtuzumab Immunoglobulins Globulin, Immune Campath
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment: 35
Study Start Date: June 2005
Estimated Study Completion Date: September 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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%.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00129753

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Anas Younes, M.D. UT MD Anderson Cancer Center
  More Information

Study ID Numbers: 2004-0742
Study First Received: August 11, 2005
Last Updated: November 2, 2006
ClinicalTrials.gov Identifier: NCT00129753  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Antibodies, Monoclonal
Lymphatic Diseases
Antibodies
Hodgkin's disease
Immunoproliferative Disorders
Alemtuzumab
Hodgkin lymphoma, adult
Lymphoproliferative Disorders
Lymphoma
Hodgkin Disease
Immunoglobulins

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009