Susan Knox
Phase II Study of Bexxar in Relapsed/Refractory Diffuse Large Cell Lymphoma
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purpose of this study is to obtain safety and efficacy data using tositumomab or Bexxar in patients with relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL).
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Tositumomab and iodine I 131 tositumomab
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- Histologically confirmed DLCL CD20+ B cell NHL who have relapsed after chemotherapy or are chemotherapy resistant, without prior history of low grade NHL. The patient must have failed at least one chemotherapy regimen containing an anthracycline or equivalent chemotherapeutic agent.
- No anticancer treatment for three weeks prior to the treatment dose of Bexxar (six weeks if Rituximab, nitrosourea or Mitomycin C), and fully recovered from all toxicities associated with prior surgery, radiation, chemotherapy or immunotherapy
- An IRB approved signed informed consent
- Age greater and or equal to 19 years
- Prestudy Karnofsky Performance Status of >= 70%
- Acceptable laboratory status within 2 weeks prior to patient enrollment including:
o ANC of at least 1,500/mm3, platelet count at least 100,000/mm3, Hct greater than 30% and Hgb greater than 9.0 gm%
o Bilirubin less than or equal to 2.0, Creatinine less than or equal to 2.0
o Bone marrow involvement with lymphoma less than 25% (bilateral bone marrow) within 6 weeks of enrollment
- Acceptable birth control method for men and women of reproductive potential
- Female patients who are not pregnant or lactating
Key Exclusion Criteria:
- Prior myeloablative therapies with bone marrow transplantation or peripheral stem cell rescue
- Patients with impaired bone marrow reserve as indicated by one or more of the following:
o Platelet count less than 100,000/mm^3
o Hypocellular bone marrow (less than or equal to 15% cellularity)
o Marked reduction in bone marrow precursors of one or more cell lines
o History of failed stem cell collection
- Prior treatment with Fludarabine
- Prior radioimmunotherapy
- Presence of CNS lymphoma
- Patients with HIV or AIDS-related lymphoma
- Patients with evidence of myelodysplasia on bone marrow biopsy
- Patients who have received prior external beam radiation therapy to more than 25% of active bone marrow
- Patients who have received G-CSF or GM-CSF therapy within 3 weeks prior to treatment
- Pregnant or lactating women
- Presence of HAMA reactivity in patients with prior exposure to murine antibodies or proteins
- Serious nonmalignant disease or infection, which, in the opinion of the investigator, would compromise other protocol objectives
- Another primary malignancy (other than squamous cell and basal cell CA of the skin, in situ CA of the cervix, or treated prostate cancer with stable PSA) for which the patients has not been disease free for at least 3 years
- Major surgery, other than diagnostic surgery, within 4 weeks
- Patients with pleural effusion
Additional Study Details
Official Title:
Phase II Study of Bexxar in Relapsed/Refractory Diffuse Large Cell Lymphoma (DLCL)Anticipated start date:
9/14/2004Lead Sponsor:
Stanford UniversityCollaborator(s):
- Corixa
- GlaxoSmithKline
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- Response rate and duration of response
Secondary Outcomes:
- Time to Progression (TTP), Overall Survival, HAMA incidence, safety and tolerance (including collection of data on late effects)
Total Number to be Enrolled:
25Total Number to be Enrolled at Stanford:
25More Information
Secondary ID(s):
- 95337
- LYMNHL0019
- NCT00490009
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
9/2/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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