Status:
COMPLETED
Phase II Study of Campath-1H Antibody to Treat Waldenstrom's Macroglobulinemia
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Conditions:
Lymphoplasmacytic Lymphoma
Waldenstrom's Macroglobulinemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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.
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 wee...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00142181
Start Date
March 1 2003
End Date
June 1 2008
Last Update
December 21 2012
Active Locations (3)
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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