Study of Bexxar Combined With External Beam Radiation Therapy for Patients With Relapsed, Bulky Non-Hodgkin's Lymphoma

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

Study of Bexxar Combined With External Beam Radiation Therapy for Patients With Relapsed, Bulky Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00490490
• Other study ID #: LYMNHL0046
• Secondary ID: 974377479
• Status: Terminated
• Phase: Phase 2
• First received: June 20, 2007
• Last updated: June 19, 2014
• Start date: January 2007
• Est. completion date: June 2011

Study information

• Verified date: June 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

We hope to learn whether I-131 tositumomab combined with external beam radiation therapy is an effective means of treating relapsed, bulky non-Hodgkin's lymphoma. The purpose of the study is to determine the overall response rate with responses described as: Site-dependent and overall CR and functional CR (CR of CRu(Complete Response Unconfirmed)/PR with PET negativity), or PR rates.

Description:

At the present time over 1,600 patients have been treated with iodine I 131 tositumomab (Bexxar) in a variety of clinical trials. The overall clinical data demonstrate that patients with relapsed or refractory low-grade or transformed low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma derive significant therapeutic benefit from iodine I 131 tositumomab. Data describing its safety and efficacy are available for over 700 patients. In aggregate, the data demonstrate that iodine I 131 tositumomab produces: 1) high overall and complete response rates, 2) clinically meaningful prolongations of response compared to those achieved after patients last prior therapies, 3) durable complete responses, and 4) manageable toxicity in patients with low grade or transformed non-Hodgkin's lymphoma. The purpose of this study is to study the safety and efficacy of this treatment in combination with external beam radiation in patients with relapsed bulky NHL.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:- Histologically confirmed low grade CD20+ B cell 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), and fully recovered from all toxicities associated with prior surgery, radiation, chemotherapy or immunotherapy

• An IRB approved signed informed consent

• Age greater and or equal to 19 years

• Expected survival of at least 6 months

• Prestudy Performance Status of 0, 1 or 2 according to the WHO

• Acceptable laboratory status within 2 weeks prior to patient enrollment including:

• ANC of at least 1,500/mm^3, platelet count at least 100,000/mm3, Hct greater than 30% and Hgb greater than 9.0 gm

• Bilirubin less than or equal to 2.0, Creatinine less than or equal to 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 of reproductive potential

• Female patients who are not pregnant or lactating

Exclusion Criteria:- Disease progression within 3 months of last chemotherapy

• Prior myeloablative therapies with bone marrow transplantation or peripheral stem cell rescue

• Patients with impaired bone marrow reserve as indicated by one or more of the following:

• Platelet count less than 100,000/mm^3

• Hypocellular bone marrow (less than or equal to 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 CNS lymphoma

• Patients with HIV or AIDS-related lymphoma

• Patients with evidence of myelodysplasia on bone marrow biopsy or 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 G-CSF or GM-CSF therapy within 3 weeks prior to treatment

• Pregnant or lactating women

• Presence of 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 CA of the skin, in situ CA of the cervix, or treated prostate cancer with stable PSA) 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• Tositumomab and iodine I 131 tositumomab
patient specific, calculated, IV

Procedure:
• External beam radiotherapy
patient specific, calculated

Drug:
• SSKI
130 mg, PO

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine percentage of patients with CR at 12 weeks (CR or CRu/PR with PET negativity)		12 weeks	Yes
Secondary	Overall Response Rate (CR + PR), irradiated Site-dependent functional CR (CR of CRu/PR with PET negativity), or PR rate		12 weeks	Yes
Secondary	Duration of Response		12 weeks	Yes
Secondary	Determination of toxicity associated with the addition of XRT to involved bulky sites of disease with concurrent Iodine I-131 Tositumomab therapy (Bexxar), Time to Progression (TTP), Overall Survival, HAMA incidence, Toxicity that triggers the stopping r		12 weeks	Yes