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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00490490
First received: June 20, 2007
Last updated: September 17, 2013
Last verified: September 2013

June 20, 2007
September 17, 2013
January 2007
January 2013   (final data collection date for primary outcome measure)
Determine percentage of patients with CR at 12 weeks (CR or CRu/PR with PET negativity) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Percentage of patients with CR (CR or CRu/PR with PET negativity). [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT00490490 on ClinicalTrials.gov Archive Site
  • Overall Response Rate (CR + PR), irradiated Site-dependent functional CR (CR of CRu/PR with PET negativity), or PR rate [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Duration of Response [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Overall Response Rate (CR + PR), irradiated Site-dependent functional CR (CR of CRu/PR with PET negativity), or PR rate. [ Time Frame: Following treatment ]
  • Duration of Response [ Time Frame: Following treatment ]
  • 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 rule. [ Time Frame: During and following treatment ]
Not Provided
Not Provided
 
Study of Bexxar Combined With External Beam Radiation Therapy for Patients With Relapsed, Bulky Non-Hodgkin's Lymphoma
Study of Bexxar Combined With External Beam Radiation Therapy for Patients With Relapsed, Bulky Non-Hodgkin's Lymphoma

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma, Non-Hodgkin
  • Drug: Tositumomab and iodine I 131 tositumomab
    patient specific, calculated, IV
    Other Name: Bexxar
  • Procedure: External beam radiotherapy
    patient specific, calculated
    Other Name: teletherapy
  • Drug: SSKI
    130 mg, PO
    Other Names:
    • potassium iodide,
    • Lugol's solution
Experimental: Tositumomab and iodine I 131 tositumomab

Dosimetric dose: 450 mg of Tositumomab infused over 1 hour ,5 mCi (0.18 GBq) Iodine I 131 Tositumomab (35mg) infused over 20 minutes followed by a 10 minute saline flush.

Therapeutic dose: 450 mg of Tositumomab infused over 1 hour, individualized mCi (GBq) activity of Iodine I 131 Tositumomab (35 mg) infused over 20 minutes followed by a 10 minute saline flush.

Interventions:
  • Drug: Tositumomab and iodine I 131 tositumomab
  • Procedure: External beam radiotherapy
  • Drug: SSKI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00490490
LYMNHL0046, 97437, 7479
Yes
Stanford University
Stanford University
GlaxoSmithKline
Principal Investigator: Susan J Knox Stanford University
Stanford University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP