Susan Knox
Study of Bexxar Combined With External Beam Radiation Therapy for Patients With Relapsed, Bulky Non-Hodgkin's Lymphoma
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
We hope to learn whether I-131 tositumomab combined with external beam radiation therapy is an effective means of treating relapsed, bulky non-Hodgkin's lymphoma. The purpose of the study is to determine the overall response rate with responses described as: Site-dependent and overall CR and functional CR (CR of CRu/PR with PET negativity), or PR rates.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Tositumomab and iodine I 131 tositumomab
- Procedure: External beam radiotherapy
Phase:
Phase 2Eligibility
Ages Eligible for Study:
19 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 low grade CD20+ B cell NHL patients who have relapsed after chemotherapy or are chemotherapy resistant and have one or more sites of disease measuring more than 5 cm.
- The patients must have failed at least one chemotherapy regimen
- No anticancer treatment for three weeks prior to study initiation (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
- Expected survival of at least 6 months
- Prestudy Performance Status of 0, 1 or 2 according to the WHO
- 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
o Acceptable birth control method for men and women of reproductive potential
o Female patients who are not pregnant or lactating
Key Exclusion Criteria:
- Disease progression within 3 months of last chemotherapy
- 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:
0 Platelet count less than 100,000/mm3
0 Hypocellular bone marrow (less than or equal to 15% cellularity)
0 Marked reduction in bone marrow precursors of one or more cell lines
0 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 or abnormal bone marrow cytogenetics
- 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 and/or sponsor, 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:
Study of Bexxar Combined With External Beam Radiation Therapy for Patients With Relapsed, Bulky Non-Hodgkin's LymphomaAnticipated start date:
1/29/2007Lead Sponsor:
Stanford UniversityCollaborator(s):
- GlaxoSmithKline
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- Percentage of patients with CR (CR or CRu/PR with PET negativity)
Secondary Outcomes:
- Overall Response Rate (CR + PR), irradiated Site-dependent functional CR (CR of CRu/PR with PET negativity), or PR rate
- Duration of Response
- Toxicity associated with the addition of XRT to involved bulky sites of disease with concurrent Iodine I-131 Tositumomab therapy (Bexxar)
- Time to Progression (TTP)
- Overall Survival
- HAMA incidence
- Toxicity that triggers the stopping rule
Total Number to be Enrolled:
25Total Number to be Enrolled at Stanford:
25More Information
Secondary ID(s):
- 97437
- LYMNHL0046
- NCT00490490
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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