LymphomaPhase 1NCT00028613
Radiolabeled Monoclonal Antibody in Treating Patients With Previously Treated Large Cell Lymphoma
A Phase 1 study testing iodine I 131 monoclonal antibody Lym-1 in people with Lymphoma, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances such as radioactive iodine to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibodies in treating patients who have large cell lymphoma that has… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- iodine I 131 monoclonal antibody Lym-1
- Type of treatment
- Surgery or procedure
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2001to Oct 2001
- Phase
- Phase 1
- 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
- Histologic diagnosis of B-cell diffuse large cell lymphoma (REAL classification system) confirmed by an independent central pathology reviewer.
- The tumor's B-cell phenotype will be confirmed by positive L-26 (CD20).
- Previous treatment with 2 common combination chemotherapy regimens. Patients previously treated with unlabeled monoclonal antibody therapy are eligible.
- Men or women at least 18 years of age.
- Karnofsky Performance Score (KPS) estimated to be > 60 at the time of the scheduled therapeutic dose of 131I-Lym-1.
- Life expectancy estimated to be at least 3 months from the time of the therapeutic dose of 131I Lym-1.
- Measurable disease demonstrable by physical examination or computerized tomography (CT).
- CT scan evidence of at least one indicator lesion with at least one diameter that measures > 2 cm. (The CT scan should be done within 2 weeks of the imaging study.)
Who cannot join
- Inability or unwillingness to comply with the following:
- Bone marrow biopsy
- Return for follow-up visits
- Remaining motionless for extended periods of time for imaging procedures
- Serial blood/urine sampling (for dosimetry patients only)
- Pregnancy (Women of childbearing potential must be practicing an effective method of contraception.)
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- Presence of a second malignancy except for basal cell skin carcinoma or carcinoma in-situ of the cervix
- Presence of active lymphomatous meningitis or other CNS involvement with lymphoma.
- HIV positive patients.
- Prior total body irradiation, or a course of prior radiation > 3,000 cGy delivered to > 20% of the central marrow or the lumbar vertebrae within 6 months of screening.
- Serum creatinine or total bilirubin > 2 x the upper limit of normal.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase > 3 x the upper limit of normal.
- Significant marrow lymphoma (defined as lymphoma cells constituting greater than 20% of the hematopoietic marrow elements from an iliac crest biopsy). A prior bone marrow biopsy is acceptable if it meets the following criteria:
- If there is prior bone marrow involvement, the biopsy must be performed within 45 days of screening.
- If there is no prior bone marrow involvement, the biopsy must be performed within 90 days of screening
- WBC count < 3,500/mm3, granulocyte count < 1,500/mm3, or platelet count < 125,000/mm3.
- Positive human anti-mouse antibodies (HAMA) serum values, defined as > 74 ng/mL at screening.
- Patients who have not recovered from toxicities of most recent anti-lymphoma therapy.
- Treatment with:
- Colony stimulating factor G-CSF or GM-CSF within 120 hours of screening laboratory assessment.
- Erythropoietin (EPO) within a month of screening laboratory assessment
- Whole blood or platelet transfusion within 120 hours of screening laboratory assessment
- History or electrocardiographic (ECG) evidence of Q-wave myocardial infarction within 6 months of screening or congestive heart failure (CHF; NYHA Stage III or IV).
- Known hypersensitivity to iodine or iodine-containing organic substances.
- Patients who require therapy with anticoagulants or antiplatelet drugs which cannot be discontinued during the study.
- Patients who are known to have antiplatelet antibodies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Safety Study Of 131I-Lym-1 For The Treatment Of Previously Treated Diffuse Large B-Cell Lymphoma
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances such as radioactive iodine to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibodies in treating patients who have large cell lymphoma that has been previously treated.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of iodine I 131 monoclonal antibody Lym-1 in patients with previously treated diffuse large cell lymphoma.
- Determine the safety of this drug in these patients.
- Determine the response of patients to this drug.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive unlabeled monoclonal antibody Lym-1 IV over 40 minutes followed 15-30 minutes later by iodine I 131 monoclonal antibody Lym-1 IV over 2 minutes.
Cohorts of 3-6 patients receive escalating doses of iodine I 131 monoclonal antibody Lym-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed weekly for 8 weeks and then every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 8-36 patients will be accrued for this study.
- Conditions
- Lymphoma
- Being tested
- iodine I 131 monoclonal antibody Lym-1
- Keywords
- recurrent adult diffuse large cell lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iodine I 131 monoclonal antibody Lym-1Radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2003 (estimated)
- Study startMar 2001
- Primary completionOct 2001
- Study completionOct 2001
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 Case Comprehensive Cancer CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Omer N. Koc, MD, Study chair, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00028613
- Sponsor's protocol ID
- BRLX1400
- Other IDs
- CWRU-BRLX-1400, BRLX-303680, CWRU-090036, NCI-G01-2038
- Status last verified
- Jan 2014
- First submitted
- 4 Jan 2002
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Safety Study Of 131I-Lym-1 For The Treatment Of Previously Treated Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00028613
- Acronym / sponsor ID
- BRLX1400
- Conditions
- Lymphoma
- Keywords
- recurrent adult diffuse large cell lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2001
- Primary completion
- Oct 2001 (actual)
- Study completion
- Oct 2001 (actual)
- First posted
- 30 Jun 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: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances such as radioactive iodine to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibodies in treating patients who have large cell lymphoma that has been previously treated.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of iodine I 131 monoclonal antibody Lym-1 in patients with previously treated diffuse large cell lymphoma.
- Determine the safety of this drug in these patients.
- Determine the response of patients to this drug.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive unlabeled monoclonal antibody Lym-1 IV over 40 minutes followed 15-30 minutes later by iodine I 131 monoclonal antibody Lym-1 IV over 2 minutes.
Cohorts of 3-6 patients receive escalating doses of iodine I 131 monoclonal antibody Lym-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed weekly for 8 weeks and then every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 8-36 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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 (8 listed)
- Histologic diagnosis of B-cell diffuse large cell lymphoma (REAL classification system) confirmed by an independent central pathology reviewer.
- The tumor's B-cell phenotype will be confirmed by positive L-26 (CD20).
- Previous treatment with 2 common combination chemotherapy regimens. Patients previously treated with unlabeled monoclonal antibody therapy are eligible.
- Men or women at least 18 years of age.
- Karnofsky Performance Score (KPS) estimated to be > 60 at the time of the scheduled therapeutic dose of 131I-Lym-1.
Key exclusion criteria (26 listed)
- Inability or unwillingness to comply with the following:
- Bone marrow biopsy
- Return for follow-up visits
- Remaining motionless for extended periods of time for imaging procedures
- Serial blood/urine sampling (for dosimetry patients only)
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 I 131 monoclonal antibody Lym-1 | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
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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.
Omer N. Koc, MD study chair
Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing iodine I 131 monoclonal antibody Lym-1 in people with Lymphoma, run by Case Comprehensive Cancer Center 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 8 inclusion and 26 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: finished, as of the sponsor's last update on 9 Jan 2014. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 9 Jan 2014.