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

This study has been terminated.
(Low Accrual)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Susan Knox, Stanford University
ClinicalTrials.gov Identifier:
NCT00490490
First received: June 20, 2007
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Lymphoma, Non-Hodgkin
Drug: Tositumomab and iodine I 131 tositumomab
Procedure: External beam radiotherapy
Drug: SSKI
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Bexxar Combined With External Beam Radiation Therapy for Patients With Relapsed, Bulky Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 8
Study Start Date: January 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Detailed 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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490490

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
GlaxoSmithKline
Investigators
Principal Investigator: Susan J Knox Stanford University
  More Information

No publications provided

Responsible Party: Susan Knox, Associate Professor of Radiation Oncology, Stanford University
ClinicalTrials.gov Identifier: NCT00490490     History of Changes
Other Study ID Numbers: LYMNHL0046, 97437, 7479
Study First Received: June 20, 2007
Last Updated: June 19, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Iodine
Cadexomer iodine
Lugol's solution
Iodine-131 anti-B1 antibody
Antibodies, Monoclonal
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hemostatics
Coagulants
Hematologic Agents
Antineoplastic Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 26, 2014