Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy

NCT00490490 | Terminated Phase 2 Results DMC

• 3 other identifiers: IRB-0747997437LYMNHL0046
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the response rate of patients with relapsed or refractory low-grade or transformed low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma to Iodine-131 (I-131) tositumomab (Bexxar) therapy plus local palliative radiation therapy (XRT).

Conditions

Lymphoma, Non-Hodgkin

Outcome Measures

Primary Outcomes (1)

• Complete Response (CR) Rate

  Participants assessed for by the following Complete Response (CR) criteria CR or Functional CR * No evidence of disease and symptoms * Any macroscopic nodules detected in any organs no longer present. * Any palpable lymph node is normal and greatest diameter is \< 1.0 cm. * The enlarged organs decreased in size and not palpable * The bone marrow biopsy and aspirate are negative for disease * Negative for disease by PET-scan (functional CR) CR Unconfirmed (CRu) criteria * No evidence of disease and symptoms * Any lymph node mass \> 1.0 cm\^2 diameter has regressed is size by more than 75%. * No macroscopic nodules in any organs * Any palpable lymph node is normal and greatest diameter is \< 1.0 cm. * The bone marrow biopsy and aspirate are negative for disease * The bone marrow biopsy may have increased number or size of lymphoid aggregates without cytologic or architectural atypia

  12 weeks

Secondary Outcomes (2)

• Overall Response Rate (ORR)

  12 weeks

• Time-to-Progression (TTP)

  2 years

Study Arms (1)

Tositumomab + XRT + KI

EXPERIMENTAL

Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)

Drug: Bexxar (tositumomab); Procedure: External beam radiotherapy (XRT); Drug: Potassium Iodide (KI)

Interventions

Bexxar (tositumomab) DRUG

Tositumomab is a CD20-directed radiotherapeutic (131-iodine) monoclonal antibody indicated for the treatment of patients with CD20-positive, relapsed or refractory, low-grade, follicular, or transformed non-Hodgkin's lymphoma who have progressed during or after rituximab therapy, including patients with rituximab-refractory non-Hodgkin's lymphoma. Tositumomab (standard regimen) will be administered at whole body exposure of 75 cGy.

Also known as: 131-iodine tositumomab

Tositumomab + XRT + KI

External beam radiotherapy (XRT) PROCEDURE

Patient-specific XRT will begin within 24 hours of administration of the therapeutic dose of tositumomab. Subjects will receive local XRT to bulky sites of disease measuring at least 5 cm in at least one dimension. The size and number of fields to be treated will determined by the investigators, but will encompass the patient's most symptomatic/threatening site(s) of disease and not cumulatively include more than 25% of the active bone marrow. Subjects will be treated with the 2 x 2 Gy regimen (2 daily fractions of 2 Gy). Sites of disease previously-irradiated with 30 to 40 Gy will not be treated on this study.

Also known as: Radiotherapy (RT)

Tositumomab + XRT + KI

Potassium Iodide (KI) DRUG

Potassium iodide (KI) will be administered as: * Saturated solution potassium iodide (SSKI) 4 drops orally 3-times-a-day, * Lugol's solution 20 drops orally 3-times-a-day, OR * KI tablets 130 mg orally once per day KI treatment will start at least 24 hours prior to tositumomab, and continue daily for 14 days following the last dose of tositumomab

Also known as: Saturated Solution Potassium Iodide (SSKI), Lugol's solution, Potassium iodide tablets

Tositumomab + XRT + KI

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed low grade CD20+ B cell non-Hodgkin lymphoma (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)
• Fully recovered from all toxicities associated with prior surgery, radiation, chemotherapy or immunotherapy
• An institutional review board- (IRB)-approved signed informed consent
• Age 19 years or older
• Expected survival of at least 6 months
• Prestudy Performance Status of 0, 1 or 2 according to the World Health Organization (WHO)
• Absolute neutrophil count (ANC) of at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hct \> 30%
• Hgb \> 9.0 gm
• Bilirubin ≤ 2.0
• Creatinine ≤ 2.0
• Bone marrow involvement with lymphoma less than 25% (bilateral bone marrow) within 6 weeks of enrollment

You may not qualify if:

• Disease progression within 3 months of last chemotherapy
• Prior myeloablative therapies with bone marrow transplantation or peripheral stem cell rescue
• Platelet count less than 100,000/mm³
• Hypocellular bone marrow (≤ 15% cellularity)
• Marked reduction in bone marrow precursors of one or more cell lines
• History of failed stem cell collection
• Prior treatment with fludarabine
• Prior radioimmunotherapy
• Presence of central nervous system (CNS) lymphoma
• HIV or AIDS-related lymphoma
• Evidence of myelodysplasia on bone marrow biopsy
• 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 filgrastim
• Sargramostim therapy within 3 weeks prior to treatment

Sponsors & Collaborators

• Stanford University: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

tositumomab I-131; Radiotherapy; Potassium Iodide; Lugol's solution

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Iodides; Iodine Compounds; Inorganic Chemicals; Potassium Compounds

Results Point of Contact

• Title: Susan J. Knox, MD, Associate Professor of Radiation Oncology
• Organization: Stanford University Medical Center

sknox@stanford.edu

(650) 725-2720

Study Officials

• Susan J Knox

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiation Oncology

Study Record Dates

• First Submitted: June 20, 2007
• First Posted: June 22, 2007
• Study Start: January 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2013
• Last Updated: March 29, 2017
• Results First Posted: March 29, 2017

Record last verified: 2017-02

Locations

US (1)