Phase II Study of Bexxar in Relapsed/Refractory Diffuse Large Cell Lymphoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Stanford University.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Stanford University
Collaborators:
Corixa Corporation
GlaxoSmithKline
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00490009
First received: June 20, 2007
Last updated: May 18, 2011
Last verified: May 2011
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Purpose
The purpose of this study is to obtain safety and efficacy data using tositumomab or Bexxar in patients with relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL).
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: Tositumomab and iodine I 131 tositumomab Drug: Tylenol Drug: Benadryl Drug: SSKI |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Bexxar in Relapsed/Refractory Diffuse Large Cell Lymphoma (DLCL) |
Resource links provided by NLM:
Drug Information available for:
Promethazine hydrochloride
Diphenhydramine
Promethazine
Acetaminophen
Diphenhydramine hydrochloride
Iodine
Potassium iodide
Sodium iodide I 131
Iodide
Diphenhydramine citrate
Tositumomab
U.S. FDA Resources
Further study details as provided by Stanford University:
Primary Outcome Measures:
- Response rate and duration of response [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to Progression (TTP), Overall Survival, HAMA incidence, safety and tolerance (including collection of data on late effects) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 25 |
| Study Start Date: | September 2004 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Tositumomab and iodine I 131 tositumomab
patient specific, IV
Other Name: Bexxar
Drug: Tylenol
650 mg, oral
Other Name: acetaminophen
Drug: Benadryl
50 mg, oral
Other Name: Diphenhydramine
Drug: SSKI
130 mg, oral
Other Name: potassium iodide
New treatment modalities are needed for diffuse large cell B cell non-Hodgkin's lymphoma (DLCL). Only 35-40% of patients with DLCL are curable with standard therapy. Therefore, approximately 60-65% of DLCL patients subsequently need salvage therapy. Salvage regimens (e.g. ESHAP, DHAP, (R)-ICE, etc) are very toxic, especially in elderly patients, and have a response rate (RR) of only 45-60% in these patients. The median survival from the time of relapse is less than one year and only a small fraction of such patients benefit from autologous stem cell transplant (ASCT).
There is a lack of efficacious treatment options for patients with relapsed/refractory 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed DLCL CD20+ B cell 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 (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
- Prestudy Karnofsky Performance Status of >= 70%
Acceptable laboratory status within 2 weeks prior to patient enrollment including:
- ANC of at least 1,500/mm3, 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:
- 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
- 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, 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490009
Locations
| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
Sponsors and Collaborators
Stanford University
Corixa Corporation
GlaxoSmithKline
Investigators
| Principal Investigator: | Susan J Knox | Stanford University |
More Information
No publications provided
| Responsible Party: | Susan J Knox, Stanford University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00490009 History of Changes |
| Other Study ID Numbers: | LYMNHL0019, 95337, LYMNHL0019 |
| Study First Received: | June 20, 2007 |
| Last Updated: | May 18, 2011 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell Acetaminophen Diphenhydramine Iodine-131 anti-B1 antibody Antibodies, Monoclonal Antipyretics |
Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Antiemetics Autonomic Agents Gastrointestinal Agents Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 22, 2013