Clinical trial NCT00490490: Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy
Official title: Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy for Patients With Relapsed, Bulky Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lymphoma, Non-Hodgkin
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2007-06-22
Enrollment: 8
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Detailed description: Response will be assessed on the basis of the presence or absence of measurable lesion ≥ 1.4 x 1.4 cm (operationally defined as ≥ 2.0 cm2) by radiographic evaluation OR ≥ 1.0 cm in greatest diameter detected by palpation on physical exam

Eligibility criteria: INCLUSION CRITERIA

* 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
* Acceptable birth control method for men and women

EXCLUSION CRITERIA

* 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
* Presence of human anti-mouse antibody (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 cancer of the skin, in situ carcinoma of the cervix, or treated prostate cancer with stable prostate-specific antigen, PSA) for which the patients has not been disease free for at least 3 years
* Major surgery, other than diagnostic surgery within 4 weeks
* Pleural effusion
* Pregnant
* Lactating

Primary outcomes:
measure: Complete Response (CR) Rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 12 weeks
measure: Time-to-Progression (TTP)
timeFrame: 2 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Susan J Knox
role: PRINCIPAL_INVESTIGATOR
References: