LymphomaPhase 2NCT00072449
Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma
A Phase 2 study testing rituximab in people with Lymphoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 9 sites in United States.
Trial summary
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have refractory or relapsed primary CNS lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 9 sitesUnited States
- Study dates
- May 2004to Jun 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
DISEASE CHARACTERISTICS:
- Histologically confirmed primary CNS lymphoma based on 1 of the following:
- Histologically confirmed non-Hodgkin's B-cell lymphoma by brain biopsy or resection
- Positive cerebrospinal fluid (CSF) cytology or immunohistochemical diagnosis of CSF monoclonality with or without measurable intracranial disease
- Histologically confirmed vitreal lymphoma with measurable intracranial tumor
- CD20 positive by brain biopsy
- Measurable (greater than 1 cm in diameter) tumor by CT scan or MRI
- Progressed during first-line chemotherapy and/or radiotherapy OR relapsed after initial successful treatment
- No systemic lymphoma by CT scan of the chest, abdomen, and pelvis with contrast
- No leptomeningeal lymphoma by lumbar puncture for CNS cytology/flow cytometry
- No ocular lymphoma by slit lamp examination
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9.0 g/dL
Hepatic
- Bilirubin less than 1.5 mg/dL
- Transaminases less than 4 times upper limit of normal
Renal
- Creatinine less than 1.5 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 year after study participation
- HIV negative
- Mini mental status examination score at least 15
- No concurrent serious infection
- No other medical illness that would preclude study treatment
- No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 90 days since prior biologic therapy
- No prior rituximab
- No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
Chemotherapy
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- At least 3 months since prior radiotherapy
Surgery
- Not specified
Other
- Recovered from prior therapy
- More than 90 days since prior investigational drugs
- More than 90 days since prior use of a therapeutic device
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, 48202
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, 33612-9497
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: A Phase II Study Of Anti-CD20 Monoclonal Antibody (Rituximab) Therapy For Patients With Refractory Or Relapsed Primary CNS Lymphoma (PCNSL)
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have refractory or relapsed primary CNS lymphoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the radiographic response proportion in patients with refractory or recurrent primary CNS lymphoma treated with rituximab.
Secondary
- Determine the progression-free and overall survival of patients treated with this drug.
- Determine the toxicity profile of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of rituximab off study at the discretion of the treating physician.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 5-9 months.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabBiological
| Study group | Role | What they receive |
|---|---|---|
| Rituximab monotherapy | Experimental | Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks Receives: Biological: rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Response
it at any time point patient progresses no more scans are required, patient is off study
Measured: 1 month, 2 months and then q3months
Secondary outcomes (3)
Progression-free Survival
pt had MRI every 3 months
Measured: pt had MRI q3months
Overall Survival
survival was evaluated q 2months
Measured: 47 months
Toxicity
patients only received drug for 8 weeks
Measured: 8 weeks - 2 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2003 (estimated)
- Study startMay 2004
- Primary completionMar 2009
- Study completionJun 2010
Why it stopped: slow accrual and lack of resources and priority due to combining 2 consortia
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Tracy Batchelor, MD, MPH, Study chair, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00072449
- Sponsor's protocol ID
- NABTT-2201 CDR0000339737
- Other IDs
- U01CA062475, NABTT-2201
- Status last verified
- Jun 2013
- First submitted
- 4 Nov 2003
- Last updated
- 28 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Batchelor TT, Grossman SA, Mikkelsen T, Ye X, Desideri S, Lesser GJ. Rituximab monotherapy for patients with recurrent primary CNS lymphoma. Neurology. 2011 Mar 8;76(10):929-30. doi: 10.1212/WNL.0b013e31820f2d94. No abstract available.
PubMed 21383331
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of Anti-CD20 Monoclonal Antibody (Rituximab) Therapy For Patients With Refractory Or Relapsed Primary CNS Lymphoma (PCNSL)
- ClinicalTrials.gov ID
- NCT00072449
- Acronym / sponsor ID
- NABTT-2201 CDR0000339737
- Conditions
- Lymphoma
- Keywords
- primary central nervous system non-Hodgkin lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual and lack of resources and priority due to combining 2 consortia
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2004
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 6 Nov 2003 (estimated)
- Results
- Posted 28 Aug 2013
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, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have refractory or relapsed primary CNS lymphoma.
Detailed description
OBJECTIVES:
Primary
- Determine the radiographic response proportion in patients with refractory or recurrent primary CNS lymphoma treated with rituximab.
Secondary
- Determine the progression-free and overall survival of patients treated with this drug.
- Determine the toxicity profile of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of rituximab off study at the discretion of the treating physician.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 5-9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab monotherapy | Experimental | Biological: rituximabRituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks |
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| rituximab | Biological | Rituximab monotherapy |
Primary outcome
Radiographic Response
Time frame: 1 month, 2 months and then q3months
it at any time point patient progresses no more scans are required, patient is off study
3 secondary outcomes
Progression-free Survival
Time frame: pt had MRI q3months
Overall Survival
Time frame: 47 months
Toxicity
Time frame: 8 weeks - 2 cycles
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21383331Batchelor TT, Grossman SA, Mikkelsen T, Ye X, Desideri S, Lesser GJ. Rituximab monotherapy for patients with recurrent primary CNS lymphoma. Neurology. 2011 Mar 8;76(10):929-30. doi: 10.1212/WNL.0b013e31820f2d94. No abstract available.
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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.
Tracy Batchelor, MD, MPH study chair
Massachusetts General Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rituximab in people with Lymphoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 9 sites 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 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Radiographic Response (time frame: 1 month, 2 months and then q3months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00072449, which also lists 1 linked publication.
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 28 Aug 2013.