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

Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00142181
Collaborator
Brigham and Women's Hospital (Other), Beth Israel Deaconess Medical Center (Other), Massachusetts General Hospital (Other), Bayer (Industry), University of California, Los Angeles (Other), Northwestern University (Other), Arizona Oncology Associates (Other)
27
Enrollment
3
Locations
1
Arm
63
Duration (Months)
9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of Campath-1H in Patients With Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
Study Start Date :
Mar 1, 2003
Actual Primary Completion Date :
Oct 1, 2005
Actual Study Completion Date :
Jun 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. To determine the effectiveness of Campath-1H in treating patients with Waldenstrom's macroglobulinemia. [2 years]

Secondary Outcome Measures

  1. To determine the safety of Campath-1H. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Beth Isreal Deaconness Medical Center Boston Massachusetts United States 02115
2 Dana-farber Cancer Insitiute Boston Massachusetts United States 02115
3 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Steven P. Treon, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00142181
Other Study ID Numbers:
  • 02-079
First Posted:
Sep 2, 2005
Last Update Posted:
Dec 21, 2012
Last Verified:
Dec 1, 2012
Keywords provided by Steven P. Treon, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
Lymphoplasmacytic lymphoma
Waldenstrom's Macroglobulinemia
Antibody
Campath-1H
Additional relevant MeSH terms:
Lymphoma
Waldenstrom Macroglobulinemia
Alemtuzumab

Study Results

No Results Posted as of Dec 21, 2012