Status:
COMPLETED
Study of Safety and Efficacy of a Sequential Regimen Consisting of Three Cycles of Fludarabine Followed by Tositumomab and Iodine I 131 Tositumomab
Lead Sponsor:
GlaxoSmithKline
Conditions:
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a single-arm, single institution, phase II study of fludarabine monophosphate followed by Iodine I 131 Tositumomab for patients with previously untreated, advanced-stage (stage III or IV) low-...
Eligibility Criteria
Inclusion
- Patients must be age 18 years or older.
- Patients must have a histologically-confirmed diagnosis of low-grade or follicular non-Hodgkin's B-cell lymphoma.
- Patients must have Ann Arbor stage III or IV extent of disease after completing staging.
- Patients must have bi-dimensionally measurable disease. At least one lesion must have both perpendicular diameters \> 2 cm.
- Patients must have evidence that their tumor expresses the CD20 antigen by immunohistochemistry or flow cytometry.
- Patients must have no previous treatment for NHL.
- Patients must have a Karnofsky performance status of at least 60% and an anticipated survival of at least 3 months.
- Patients must have absolute granulocyte count greater than or equal to 1500 cells/mm3 and a platelet count \> 100,000 cells/mm3 within 14 days of study entry and not require sustained support with hematopoietic cytokines or transfusion of blood products.
- Patients must have adequate renal and hepatic function.
- Patients must sign IRB approved informed consent form(s) prior to study entry.
Exclusion
- Patients who received systemic steroids within 1 week of study entry, except patients on maintenance steroid therapy for a non-cancerous disease.
- Patients with evidence of active infection requiring intravenous antibiotics at the time of study entry.
- Patients with New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation.
- Patients with known HIV Infection.
- Patients with known brain or leptomeningeal metastases.
- Patients who are pregnant or nursing. Patients of childbearing potential must undergo a pregnancy test at screening and on the day fludarabine treatment is started. Treatment is not to be administered until a negative result is obtained. Males and females must agree to use effective contraception for 6 months following the iodine I 131 tositumomab therapy.
- Patients with prior malignancy other than lymphoma, except for adequately-treated skin cancer in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years.
- Patients with hypersensitivity to fludarabine.
- Patients who are receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.
- Patients who are HAMA positive.
- Patients with previous allergic reaction to iodine. This does not include reacting to intravenous iodine containing contrast materials.
- Inclusion Criteria for Iodine I 131 Tositumomab Therapy
- Patients who completed 3 cycles of fludarabine.
- Patients must have absolute granulocyte count ≥ to 1500/mm3, platelet count of ≥ 100,000/mm3 (≥ 150,000/mm3 if \> 25% bone marrow involvement at restaging), and not require sustained support with hematopoietic cytokines or transfusions with blood products.
- Patients must have adequate renal and hepatic function.
- Exclusion criteria for Antibody Therapy
- Patients with active obstructive hydronephrosis.
- Patients with evidence of active infection requiring intravenous antibiotics.
- Patients who are pregnant.
Key Trial Info
Start Date :
August 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00933335
Start Date
August 1 1998
End Date
August 1 2010
Last Update
January 18 2017
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