Clinical trial NCT00490009: Phase 2 Study of Bexxar in Relapsed/Refractory DLCL
Official title: Phase 2 Study of Bexxar in Relapsed/Refractory Diffuse Large Cell Lymphoma (DLCL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Corixa Corporation
name: GlaxoSmithKline
First posted: 2007-06-22
Enrollment: 9
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 this study is to obtain safety and efficacy data using Bexxar in patients with relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL).

Detailed description: There is a lack of efficacious treatment options for patients with relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL) who are not appropriate candidates for stem cell transplantation. DLCL is a relatively radiosensitive disease and patients with DLCL have been reported to respond to anti-CD20 monoclonal antibody (MAB) therapy. Therefore, radioimmunotherapy targeting CD20 is a rational and promising therapeutic approach for this patient population.

This study evaluated if Bexxar is safe and efficacious for diffuse large cell Non-Hodgkin's lymphoma.

Eligibility criteria: Inclusion Criteria:

* Histologically-confirmed, diffuse large cell lymphoma (DLCL), CD20+ B-cell non-Hodgkin lymphoma (NHL) who have relapsed after chemotherapy or are chemotherapy resistant, without prior history of low grade NHL. The patient must have failed at least one chemotherapy regimen containing an anthracycline or equivalent chemotherapeutic agent.
* No anticancer treatment for three weeks prior to the treatment dose of Bexxar (6 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
* Prestudy Karnofsky Performance Status of ≥ 70%
* Absolute neutrophil count (ANC) ≥ 1,500/mm³
* Platelet count ≥ 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
* Female patients who are not pregnant
* Not lactating

Exclusion Criteria:

* Prior myeloablative therapies with bone marrow transplantation or peripheral stem cell rescue
* Platelet count \< 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
* Patients with known HIV or AIDS-related lymphoma
* Patients with evidence of myelodysplasia on bone marrow biopsy
* Patients who have received prior external beam radiation therapy to more than 25% of active bone marrow
* Patients who have received filgrastim or sargramostim therapy within 3 weeks prior to treatment
* Pregnant
* Lactating
* 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, would compromise other protocol objectives
* Another primary malignancy (other than squamous cell and basal cell carcinoma of the skin, in situ carcinoma of the cervix, or treated prostate cancer with stable prostate specific antigen levels) for which the patients has not been disease-free for at least 3 years
* Major surgery, other than diagnostic surgery, within 4 weeks
* Patients with pleural effusion

Primary outcomes:
measure: Clinical Response Rate
timeFrame: 6 years
Secondary outcomes:
measure: Time to Progression (TTP)
timeFrame: 1.5 months; 3 months; 6 months; or Not Progressed
measure: Overall Survival (OS) Rate
timeFrame: 6 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: