LymphomaPhase 3NCT00004874
Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma
A Phase 3 study testing tositumomab and iodine I 131 tositumomab in people with Lymphoma, run by University of Nebraska at 1 site in United States.
Trial summary
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase III trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory non-Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 19 to 120 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- tositumomab and iodine I 131 tositumomab
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1998to Nov 2012
- Phase
- Phase 3
- 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 19 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven relapsed or refractory, low grade or transformed low grade B-cell non-Hodgkin's lymphoma including the following: Small lymphocytic Follicular small cleaved cell Follicular mixed small cleaved and large cell (less than 50% large cell component) Tumor must be positive for CD20 antigen Relapse or disease progression following at least 1 chemotherapy regimen or failure to achieve an objective response (complete or partial response) on prior chemotherapy regimen No disease progression, within 1 year of irradiation, arising in a field previously irradiated with more than 3500 cGy Mean of no greater than 25% intratrabecular marrow space involved with lymphoma on bilateral iliac crest bone marrow biopsy A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS: Age: 19 and over Performance status: Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) AST less than 5 times ULN Renal: Creatinine less than 1.5 times ULN No active obstructive hydronephrosis Cardiovascular: No New York Heart Association class III or IV heart disease Other: No active infection requiring IV antibiotics No other concurrent illness that would preclude evaluation No prior malignancy within the past 5 years except adequately treated skin cancer, carcinoma in situ of the cervix, or lymphoma HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No prior allergic reaction to iodine other than IV iodine containing contrast materials Human antimouse antibody negative
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy or cytokine treatment and recovered No prior hematologic stem cell transplantation Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (at least 6 weeks since prior nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No prior radioimmunotherapy Surgery: Not specified Other: No concurrent IV antibiotics
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
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
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase III trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
Read the detailed description
OBJECTIVES: I. Determine the efficacy and safety of iodine I 131 monoclonal antibody anti-B1 in patients with relapsed or refractory, low grade or transformed low grade B-cell non-Hodgkin's lymphoma.
OUTLINE: On day 1, patients receive unlabeled monoclonal antibody anti-B1 (MOAB anti-B1) IV over 1 hour followed by a tracer dose of iodine I 131 MOAB anti-B1 IV over 30 minutes to determine biodistribution and a therapeutic dose of iodine I 131 MOAB anti-B1. Patients receive unlabeled MOAB anti-B1 IV over 1 hour followed by a therapeutic dose of iodine I 131 MOAB anti-B1 IV over 30 minutes on day 8. Patients are followed at weeks 13 and 25 and then every 6 months for up to 2 years.
PROJECTED ACCRUAL: Expanded Access Trial, no maximum accrual
- Conditions
- Lymphoma
- Being tested
- tositumomab and iodine I 131 tositumomab
- Keywords
- recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent small lymphocytic lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Follicular, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tositumomab and iodine I 131 tositumomabRadiation
Also called Iodine-131 Anti-B1 Antibody
Dosimetric Dose:Unlabeled anti-B1 (450mg) will be given as peripheral or central IV infusion over one hour or longer depending upon rate-dependent side effects. A trace-labeled dose of 131I-anti-B will be infused over 20 minutes, if rate-dependent side effects permit. An amount of unlabeled Anti-B1 Antibody is added to the 5 mCi of Iodine-131 Anti-B1 Antibody sufficient to result in a final amount of 35 mg of Anti-B1 antibody. On study Day 7 (may be delayed up to study Day 14), patients will receive the therapeutic dose, which consists of an infusion of 450mg of Anti-B1 Antibody followed by an infusion of Iodine-131 Anti-B1 Antibody.
What is being measured
The primary outcome is the main question the study is designed to answer.
Expanded Access
The primary objective of this stud is to make Iodin-131 Anti-B1 Antibody more broadly available to patients
Measured: Study completion
Secondary outcomes (2)
Safety
Secondary endpoints of the study will be to obtain additional information on the safety of Iodine-131 Anti-B1 Antibody
Measured: Study completion
efficacy
Secondary endpoints of the study will be to obtain additional information on the efficacy of Iodine-131 Anti-B1 Antibody
Measured: study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2003 (estimated)
- Study startNov 1998
- Primary completionApr 2002
- Study completionNov 2012
Why it stopped: lack of FDA approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Coulter Pharmaceutical, Inc.
- Responsible party
- Principal investigator, Julie M Vose, MD, University of Nebraska
- Investigators
- Julie M. Vose, MD, Study chair, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004874
- Sponsor's protocol ID
- 259-98
- Other IDs
- P30CA036727, UNMC-259-98, COULTER-CP-98-020
- Status last verified
- Jan 2018
- First submitted
- 7 Mar 2000
- Last updated
- 17 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. 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
- NCT00004874
- Acronym / sponsor ID
- 259-98
- Conditions
- Lymphoma
- Keywords
- recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent small lymphocytic lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of FDA approval
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Coulter Pharmaceutical, Inc.
- Study start
- Nov 1998
- Primary completion
- Apr 2002 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 16 Dec 2003 (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.
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase III trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
Detailed description
OBJECTIVES: I. Determine the efficacy and safety of iodine I 131 monoclonal antibody anti-B1 in patients with relapsed or refractory, low grade or transformed low grade B-cell non-Hodgkin's lymphoma.
OUTLINE: On day 1, patients receive unlabeled monoclonal antibody anti-B1 (MOAB anti-B1) IV over 1 hour followed by a tracer dose of iodine I 131 MOAB anti-B1 IV over 30 minutes to determine biodistribution and a therapeutic dose of iodine I 131 MOAB anti-B1. Patients receive unlabeled MOAB anti-B1 IV over 1 hour followed by a therapeutic dose of iodine I 131 MOAB anti-B1 IV over 30 minutes on day 8. Patients are followed at weeks 13 and 25 and then every 6 months for up to 2 years.
PROJECTED ACCRUAL: Expanded Access Trial, no maximum accrual
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| tositumomab and iodine I 131 tositumomabAlso: Iodine-131 Anti-B1 AntibodyDosimetric Dose:Unlabeled anti-B1 (450mg) will be given as peripheral or central IV infusion over one hour or longer depending upon rate-dependent side effects. A trace-labeled dose of 131I-anti-B will be infused over 20 minutes, if rate-dependent side effects permit. An amount of unlabeled Anti-B1 Antibody is added to the 5 mCi of Iodine-131 Anti-B1 Antibody sufficient to result in a final amount of 35 mg of Anti-B1 antibody. On study Day 7 (may be delayed up to study Day 14), patients will receive the therapeutic dose, which consists of an infusion of 450mg of Anti-B1 Antibody followed by an infusion of Iodine-131 Anti-B1 Antibody. | Radiation | – |
Primary outcome
Expanded Access
Time frame: Study completion
The primary objective of this stud is to make Iodin-131 Anti-B1 Antibody more broadly available to patients
2 secondary outcomes
Safety
Time frame: Study completion
efficacy
Time frame: study completion
Results and safety
The study was stopped early (reason given: lack of FDA approval). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
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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.
Julie M. Vose, MD study chair
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tositumomab and iodine I 131 tositumomab in people with Lymphoma, run by University of Nebraska 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?
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: stopped early, as of the sponsor's last update on 17 Jan 2018. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of FDA approval). 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.
What does the primary outcome measure?
Expanded Access (time frame: Study completion). It is what the study was designed to measure, not a finding.
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 17 Jan 2018.