Clinical trial · Interventional
Study to Treat Relapsed Follicular Non-Hodgkin's Lymphoma With Radiation and Bexxar
Feasibility Study of External Beam Radiotherapy and Iodine-131 Tositumomab (Bexxar) for Patients With Relapsed Follicular Non-Hodgkin's Lymphoma
NCT00475332CI-TRIAL-00006269terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left our institution
Summary
Brief summary (as posted)
The purpose of this study is to determine the feasibility of treating relapsed follicular lymphoma with a combination of Bexxar and External Beam Radiotherapy (EBRT). Patients will receive EBRT (20 Gy in 10 fractions) followed by Bexxar.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| External Beam Radiation Therapy | Procedure | — | UNRESOLVED |
| Iodine I -01 Tositumomab (Bexxar) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The Primary Endpoint of the Study Will be to Determine the Feasibility of Combining External Beam Radiotherapy (EBRT) and Bexxar by Assessing the Toxicities Associated With the Treatment.
- timeFrame
- 2 yr 3 mos
- description
- 13 patients will be enrolled initially and followed for 3 months. If less than 10 of these patients reach a grade III or IV toxicity, then 12 more patients will be enrolled and the study will be deemed feasible. If 11 or more of the first group experience grade III/IV toxicity, the trial will stop early.
Secondary outcomes (1)
- measure
- The Secondary Endpoint Will be to Assess Response Rates and Patterns of Failure in Patients Treated With Bexxar and External Beam Radiotherapy (EBRT).
- timeFrame
- 2 yr 3 mos
- description
- Tumor response to treatment is measured using the RECIST criteria: Response Evaluation Criteria in Solid Tumors which defines Complete Response, Partial Response, Progressive Disease, and Stable Disease, by using tumor measurements as seen on CT or MRI
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Relapsed Stage I-IV (no evidence of bone marrow involvement) Follicular Non- Hodgkin's Lymphoma (NHF). Patients must have received at least 1 prior therapeutic regimen of chemotherapy or Rituximab and demonstrated progression as demonstrated by biopsy. * One or more of the relapsed sites must be 5 cm or greater in dimension as assessed on two dimensional imaging from CT or MRI scan. * Biopsy at time of relapse confirming continued presence of CD 20 positive follicular lymphoma. * No anti-cancer therapy for 3 weeks (six weeks if Rituximab, nitrosourea or Mitomycin C) prior to study initiation, and fully recovered from all toxicities associated with prior surgery, chemotherapy, or immunotherapy. * An IRB-approved signed informed consent. * Expected survival rate greater than 3 months. * Prestudy performance status of 0 or 1 according to the World Health Organization (WHO) criteria * Acceptable hematologic status within two weeks prior to patient registration, including: * Absolute neutrophil count (ANC) (\[segmented neutrophils + bands\] x total white blood cells) greater than 1,500/mm\^3 * Platelet counts greater than 100,000/mm\^3 * Female patients who are not pregnant or lactating. * Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician, however, abstinence is not an acceptable method). * Patients previously on Phase II drugs if no long-term toxicity is expected, and the patient has been off the drug for eight or more weeks with no significant post-treatment toxicities observed. Exclusion Criteria * Patients with impaired bone marrow reserve, as indicated by one or more of the following: * Prior myeloablative therapies with bone marrow transplantation (either autologous or allogeneic) or peripheral blood stem cell (PBSC) rescue. * Platelet count \> 100,000 cells/mm\^3 * Hypocellular bone marrow * Marked reduction in bone marrow precursors of one or more cell lines (granulocytic,megakaryocytic, erythroid). * History of failed stem cell collection * Presence of bone marrow involvement with follicular lymphoma (FL) \> 25% based on bone marrow biopsy done within 2 months of enrollment. * Evidence of transformation from original FL to a more aggressive NHL histology. * Prior radioimmunotherapy. * All relapsed sites are \< 5 cm in dimension as assessed on two dimensional imaging from CT or MRI scan. * Presence of CNS (central nervous system) involvement. * Presence of primary Non-Hodgkin Lymphoma (NHL) of bone. * Patients with HIV or AIDS-related lymphoma. * Patients with abnormal renal function: serum creatinine \> 2.0 mg/dL. * Patients who have received prior external beam radiation therapy within three months of registration. * Patients who have received G-CSF (granulocyte colony-stimulating factor) or GM-CSF (granulocyte-macrophage colony stimulating factor) therapy within two weeks prior to treatment. * Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives. * Major surgery, other than diagnostic surgery, within four weeks. * Presence of anti-murine antibody (HAMA) reactivity.
References
Publications (6)
- BACKGROUNDWiseman GA, White CA, Sparks RB, Erwin WD, Podoloff DA, Lamonica D, Bartlett NL, Parker JA, Dunn WL, Spies SM, Belanger R, Witzig TE, Leigh BR. Biodistribution and dosimetry results from a phase III prospectively randomized controlled trial of Zevalin radioimmunotherapy for low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma. Crit Rev Oncol Hematol. 2001 Jul-Aug;39(1-2):181-94. doi: 10.1016/s1040-8428(01)00107-x. PMID 11418315
- BACKGROUNDKoral KF, Dewaraja Y, Li J, Lin Q, Regan DD, Zasadny KR, Rommelfanger SG, Francis IR, Kaminski MS, Wahl RL. Update on hybrid conjugate-view SPECT tumor dosimetry and response in 131I-tositumomab therapy of previously untreated lymphoma patients. J Nucl Med. 2003 Mar;44(3):457-64. PMID 12621015
- BACKGROUNDKoral KF, Dewaraja Y, Li J, Barrett CL, Regan DD, Zasadny KR, Rommelfanger SG, Francis IR, Kaminski MS, Wahl RL. Initial results for Hybrid SPECT--conjugate-view tumor dosimetry in 131I-anti-B1 antibody therapy of previously untreated patients with lymphoma. J Nucl Med. 2000 Sep;41(9):1579-86. PMID 10994741
- BACKGROUNDGokhale AS, Mayadev J, Pohlman B, Macklis RM. Gamma camera scans and pretreatment tumor volumes as predictors of response and progression after Y-90 anti-CD20 radioimmunotherapy. Int J Radiat Oncol Biol Phys. 2005 Sep 1;63(1):194-201. doi: 10.1016/j.ijrobp.2005.01.017. PMID 16111589
- BACKGROUNDKaminski MS, Zelenetz AD, Press OW, Saleh M, Leonard J, Fehrenbacher L, Lister TA, Stagg RJ, Tidmarsh GF, Kroll S, Wahl RL, Knox SJ, Vose JM. Pivotal study of iodine I 131 tositumomab for chemotherapy-refractory low-grade or transformed low-grade B-cell non-Hodgkin's lymphomas. J Clin Oncol. 2001 Oct 1;19(19):3918-28. doi: 10.1200/JCO.2001.19.19.3918. PMID 11579112
- BACKGROUNDKaminski MS, Tuck M, Estes J, Kolstad A, Ross CW, Zasadny K, Regan D, Kison P, Fisher S, Kroll S, Wahl RL. 131I-tositumomab therapy as initial treatment for follicular lymphoma. N Engl J Med. 2005 Feb 3;352(5):441-9. doi: 10.1056/NEJMoa041511.