Phase II Study of Campath-1H Antibody to Treat Waldenstrom's Macroglobulinemia

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Bayer
University of California, Los Angeles
Northwestern University
Arizona Oncology Associates
Information provided by (Responsible Party):
Steven P. Treon, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00142181
First received: September 1, 2005
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to determine the safety and effects (good or bad) of Campath-1H antibody in the treatment of lymphoplasmacytic lymphoma.


Condition Intervention Phase
Lymphoplasmacytic Lymphoma
Waldenstrom's Macroglobulinemia
Drug: 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 Campath-1H in Patients With Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine the effectiveness of Campath-1H in treating patients with Waldenstrom's macroglobulinemia. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the safety of Campath-1H. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 27
Study Start Date: March 2003
Study Completion Date: June 2008
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Campath-1H
30 mg IV three times a week, 6-12 weeks.
Drug: Campath-1H
Participant will receive three test doses of Campath-1H (3, 10, and 30mg). If this is tolerated then they will receive Campath-IH three times a week for 6 weeks.

Detailed Description:
  • Patients will receive 3 test doses of Campath-1H (3mg, 10mg, 30mg). If the patient tolerates these three test doses, then they will receive a total of 6 weeks of Campath-1H therapy three times a week.
  • After the patient receives the first 6 weeks of therapy at the 30mg therapeutic dose they will be re-assessed by blood testing. If it is determined that their disease has progressed in the period of time while the patient was on Campath-1H, the patient will be removed from the study.
  • If it is determined that the patient has achieved a complete remission after 6 weeks of Campath-1H treatment a bone marrow biopsy will be performed to confirm complete remission and the patient will not receive any additional treatment but will be followed for a period of 2 years.
  • If the disease has remained stable or partial response has been achieved the patient will enter the second phase of therapy in which they will receive an additional 6 weeks of Campath-1H therapy. The patient will then be reassessed as described above.
  • No additional therapy (as part of this study) will be performed after a 12 week course of Campath-1H.
  • While the patient is on Campath-1H blood test will be performed at 3-6 month intervals over a period extending for 2 years following the last treatment. Bone marrow biopsies and/or aspirations will be conducted as necessary.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of lymphoplasmacytic lymphoma including patients with Waldenstrom's macroglobulinemia
  • Adequate organ function: ANC > 500/ul; PLT > 25,000/ul; serum creatinine < 2.5; serum total bilirubin and SGOT < 2.5 times the upper normal limit.
  • Age greater than 18 years
  • Life expectancy of 6 months or greater
  • ECOG performance status of 0-2

Exclusion Criteria:

  • Chemotherapy, steroid therapy, or radiation therapy within 21 days of study entry.
  • Prior Campath-1H or monoclonal antibody therapy within 3 months of study entry.
  • Pregnant women
  • Serious co-morbid disease, uncontrolled bacterial, fungal, or viral infection.
  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: NCT00142181

Locations
United States, Massachusetts
Beth Isreal Deaconness Medical Center
Boston, Massachusetts, United States, 02115
Dana-farber Cancer Insitiute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Bayer
University of California, Los Angeles
Northwestern University
Arizona Oncology Associates
Investigators
Principal Investigator: Steven P. Treon, MD, MA, PhD Dana-Farber Cancer Institute
  More Information

Publications:
Responsible Party: Steven P. Treon, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00142181     History of Changes
Other Study ID Numbers: 02-079
Study First Received: September 1, 2005
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Lymphoplasmacytic lymphoma
Waldenstrom's Macroglobulinemia
Antibody
Campath-1H

Additional relevant MeSH terms:
Lymphoma
Waldenstrom Macroglobulinemia
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Plasma Cell
Paraproteinemias
Vascular Diseases
Alemtuzumab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014