Non-Hodgkin's LymphomaNCT00022958
Expanded Access Study of Iodine-131 Anti-B1 Antibody
A study testing Iodine-131 Anti-B1 Antibody in people with Non-Hodgkin's Lymphoma, run by Corixa Corporation at 1 site in United States.
Trial summary
The primary objective of this study is to make Iodine-131 Anti-B1 Antibody more broadly available to patients. Secondary endpoints of the study will be to obtain additional information on the efficacy and safety of Iodine-131 Anti-B1 Antibody. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- Iodine-131 Anti-B1 Antibody
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 1998to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a histologically confirmed diagnosis of low-grade NHL or transformed low-grade NHL according to International Working Formulation for Clinical Usage. (The following low-grade histologies are to be included: small lymphocytic; follicular, small cleaved; and follicular, mixed small-cleaved and large cell [<50% large cell component]). Tumor must be positive for CD20 antigen.
- Patients must have been treated with at least one chemotherapy regimen and have relapsed or progressed, or failed to achieve an objective response (CR or PR) on their last chemotherapy regimen.
- Patients must have a Karnofsky performance status of at least 60% and an anticipated survival of at least 3 months.
- Patients must have an absolute granulocyte count greater than or equal to 1,500/mm3, a platelet count greater than or equal to 100,000/mm3, and not require sustained support of hematopoietic cytokines or transfusion of blood products.
- Patients must have adequate renal function (defined as serum creatinine <1.5 times upper limit of normal), hepatic function (defined as total bilirubin <1.5 times upper limit of normal), and hepatic transaminases (defined as AST <5 times upper limit of normal).
Who cannot join
- Patients with a mean of >25% of the intratrabecular marrow space involved with lymphoma on bilateral iliac crest bone marrow biopsy. Patients with a <10% lymphoma involvement on unilateral biopsy do not require bilateral biopsy.
- Patients who have received cytotoxic chemotherapy, radiation therapy, immunotherapy, or cytokine treatment within 4 weeks prior to study entry (6 weeks for nitrosourea compounds) or who exhibit persistent clinical evidence of toxicity. Patients who have received systemic steroids within 1 week of study entry are excluded, except patients on maintenance steroid therapy for a non-cancerous disease.
- Patients who have undergone treatment with either stem cell or bone marrow transplant.
- Patients with active obstructive hydronephrosis.
- Patients with evidence of active infection requiring IV antibiotics at the time of study entry.
- Patients with New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation.
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- Patients with known HIV infection.
- Patients who are pregnant or nursing. Males and females must agree to use a contraceptive method from enrollment to 6 months after receiving Iodine-131 Anti-B1 Antibody.
- Patients with prior malignancy other than lymphoma, except for adequately-treated skin cancer (basal cell or squamous cell carcinoma), in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years. Patients who have been disease-free of another cancer for greater than 5 years must be carefully assessed at the time of study entry to rule out recurrent disease.
- Patients with progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with more than 3500 cGy.
- Patients who previously received radioimmunotherapy.
- Patients who are receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.
- Patients with known brain or leptomeningeal metastases.
- Patients who are HAMA positive.
Trial locations and contacts
1 site in 1 country.
United States1 site
Central Recruiting Information
South San Francisco, California
About this study
Official title: Expanded Access Study of Iodine-131 Anti-B1 Antibody for Relapsed/Refractory Low-Grade and Transformed Low-Grade Non-Hodgkin's Lymphoma
The primary objective of this study is to make Iodine-131 Anti-B1 Antibody more broadly available to patients. Secondary endpoints of the study will be to obtain additional information on the efficacy and safety of Iodine-131 Anti-B1 Antibody.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- Iodine-131 Anti-B1 Antibody
- Keywords
- Non-Hodgkin's Lymphoma, Radioimmunotherapy, Monoclonal Antibody, Corixa, Bexxar, Anti-B1 Antibody, Tositumomab, Iodine -131 Anti-B1 Antibody, Iodine I 131 Tositumomab
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodine-131 Anti-B1 AntibodyDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2001 (estimated)
- Study startSep 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Corixa Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00022958
- Sponsor's protocol ID
- CP-98-020
- Status last verified
- Aug 2004
- First submitted
- 16 Aug 2001
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Study of Iodine-131 Anti-B1 Antibody for Relapsed/Refractory Low-Grade and Transformed Low-Grade Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00022958
- Acronym / sponsor ID
- CP-98-020
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- Non-Hodgkin's Lymphoma, Radioimmunotherapy, Monoclonal Antibody, Corixa, Bexxar, Anti-B1 Antibody, Tositumomab, Iodine -131 Anti-B1 Antibody
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Corixa CorporationIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Sep 1998
- First posted
- 20 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to make Iodine-131 Anti-B1 Antibody more broadly available to patients. Secondary endpoints of the study will be to obtain additional information on the efficacy and safety of Iodine-131 Anti-B1 Antibody.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must have a histologically confirmed diagnosis of low-grade NHL or transformed low-grade NHL according to International Working Formulation for Clinical Usage. (The following low-grade histologies are to be included: small lymphocytic; follicular, small cleaved; and follicular, mixed small-cleaved and large cell [<50% large cell component]). Tumor must be positive for CD20 antigen.
- Patients must have been treated with at least one chemotherapy regimen and have relapsed or progressed, or failed to achieve an objective response (CR or PR) on their last chemotherapy regimen.
- Patients must have a Karnofsky performance status of at least 60% and an anticipated survival of at least 3 months.
- Patients must have an absolute granulocyte count greater than or equal to 1,500/mm3, a platelet count greater than or equal to 100,000/mm3, and not require sustained support of hematopoietic cytokines or transfusion of blood products.
- Patients must have adequate renal function (defined as serum creatinine <1.5 times upper limit of normal), hepatic function (defined as total bilirubin <1.5 times upper limit of normal), and hepatic transaminases (defined as AST <5 times upper limit of normal).
Key exclusion criteria (14 listed)
- Patients with a mean of >25% of the intratrabecular marrow space involved with lymphoma on bilateral iliac crest bone marrow biopsy. Patients with a <10% lymphoma involvement on unilateral biopsy do not require bilateral biopsy.
- Patients who have received cytotoxic chemotherapy, radiation therapy, immunotherapy, or cytokine treatment within 4 weeks prior to study entry (6 weeks for nitrosourea compounds) or who exhibit persistent clinical evidence of toxicity. Patients who have received systemic steroids within 1 week of study entry are excluded, except patients on maintenance steroid therapy for a non-cancerous disease.
- Patients who have undergone treatment with either stem cell or bone marrow transplant.
- Patients with active obstructive hydronephrosis.
- Patients with evidence of active infection requiring IV antibiotics at the time of study entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iodine-131 Anti-B1 Antibody | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iodine-131 Anti-B1 Antibody in people with Non-Hodgkin's Lymphoma, run by Corixa Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.