Phase 2
Completed N=12
Safety and Efficacy Study of I-131 Tositumomab in Patients With Relapsed/Refractory Hodgkin's Lymphoma
Hodgkin's Disease
Source: ClinicalTrials.gov NCT00484874 ↗
Enrolled (actual)
12
Serious AEs
33.3%
Results posted
Aug 2018
Primary outcomePrimary: Non-myeloablative Maximum Tolerated Dose of I-131 Tositumomab That Can be Given to Patients With Relapsed/Refractory Hodgkin's Lymphoma. — 79 cGy
Summary
The purpose of this study is to find the highest safe dose of Iodine-131 Tositumomab (Bexxar®) that can be given to patients who have relapsed/refractory Hodgkin's lymphoma, what side effects these patients get when they take Bexxar® and if Bexxar® is effective in treating relapsed/refractory Hodgkin's lymphoma. Bexxar® works by delivering doses of radiation to cancer cells.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Non-myeloablative Maximum Tolerated Dose of I-131 Tositumomab That Can be Given to Patients With Relapsed/Refractory Hodgkin's Lymphoma. |
79 | — |
| PRIMARY Overall and Complete Response Rates |
25; 25 | — |
| SECONDARY Median Time to Progression Following I-131 Tositumomab Therapy. |
12 | — |
| SECONDARY Frequency of Visualization of Hodgkin's Lymphoma With I-131 Tositumomab Imaging and Tumor Radiation Absorbed Dose |
100 | — |
Eligibility Criteria
Inclusion Criteria
- Biopsy-proven Hodgkin's lymphoma that is relapsed or refractory and the patient has previously had a transplant or is ineligible for transplant
- All stages and histologic subtypes of Hodgkin's lymphoma
- Malignant cells may be CD20+ or CD20-
- May have previously had either a non-myeloablative or myeloablative allogeneic or autologous stem cell transplant
- If prior history of greater than 1 transplant, eligible if other entry criteria are met
- No upper limit on the amount of prior chemotherapy
- Must be at least 4 weeks out from their most recent chemotherapy or radiation therapy, 6 weeks if the last regimen included BCNU, or mitomycin
- Age 18 or greater
- Karnofsky performance status ≥ 60
- Organ and marrow function within 4 weeks of registration on the protocol as defined below:
- Leukocytes >2,000/mm3
- Absolute neutrophil count >1,000/ mm3
- Platelets >75,000/ mm3
- Hemoglobin >7 g/dL
- Creatinine <2.5 mg/dL
- Less than 25% bone marrow involvement with Hodgkin's lymphoma within 4 weeks of registration on the protocol
- If female, not pregnant or breast feeding
- Ability to understand and the willingness to sign a written informed consent document
- At least one measurable target lesion, measuring 1.5 cm in at least one dimension by standard CT imaging which is FDG -avid on PET/CT.
- 2-year expected survival from other diseases
Exclusion Criteria
- Receiving any other investigational agents at the same time
- Hypocellular bone marrow (less than or equal to 10% cellularity) or marked decrease in any one (or more) hematopoietic precursor within 4 weeks of registration on the protocol
- Inability to follow basic radiation safety precautions
- Active infections requiring intravenous antibiotics until after resolution of the infection
Data sourced from ClinicalTrials.gov (NCT00484874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.