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

This study has been terminated.
(Terminated due to slow accrual.)
Sponsor:
Information provided by:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00129753
First received: August 11, 2005
Last updated: October 8, 2010
Last verified: October 2010
  Purpose

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.

Condition Intervention Phase
Hodgkin's Disease
Lymphoma
Drug: Alemtuzumab (Campath-1H)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Alemtuzumab (Campath-1H) Monoclonal Antibody in Patients With Relapsed and Resistant Classical Hodgkin's Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Patients With Response [ Time Frame: After 12 weeks of therapy ] [ Designated as safety issue: Yes ]
    Response assessment of 12 weeks Campath-1H: Complete Response (CR), Partial Response (PR), No Change or Progressive Disease.


Enrollment: 0
Study Start Date: June 2005
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alemtuzumab Drug: Alemtuzumab (Campath-1H)
Escalating dose 3mg, 10 mg, 30 mg on three consecutive days, then 30 mg three times per week by subcutaneous injections for 12 weeks. Each 30 mg dose will be divided in 2 injections to be administered in each thigh.
Other Names:
  • Campath
  • Campath-1H
  • Campath-1H Monoclonal Antibody

  Show Detailed Description

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: Anas Younes, M.D. / Professor, UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00129753     History of Changes
Other Study ID Numbers: 2004-0742
Study First Received: August 11, 2005
Results First Received: April 24, 2009
Last Updated: October 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Campath-1H Monoclonal Antibody
Alemtuzumab
Campath
Campath-1H
Relapsed and Resistant Classical Hodgkin's Disease
Lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Alemtuzumab
Antibodies
Antibodies, Monoclonal
Immunoglobulins
Antineoplastic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014