Brain and Central Nervous System TumorsNCT00416819
Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
A study testing filgrastim, rituximab and cytarabine in people with Brain and Central Nervous System Tumors and Lymphoma, run by University of California, San Francisco.
Trial summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain and Central Nervous System Tumors, Lymphoma
- What is being tested?
- filgrastim, rituximab and cytarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to Feb 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed untreated primary CNS lymphoma (PCNSL) confirmed by 1 of the following methods:
- Brain biopsy or resection
- Patients diagnosed with T-cell PCNSL allowed but will not receive rituximab on study
- Cerebrospinal fluid (CSF) cytology
- Positive CSF cytology with or without measurable intracranial disease
- Vitreal biopsy
- Histologic confirmation of vitreal lymphoma with measurable intracranial tumor
- No evidence of systemic non-Hodgkin's lymphoma
- CT scan of chest, abdomen, and pelvis or bone marrow biopsy negative for extracerebral source of lymphoma
- No evidence of pleural effusions or ascites
- MRI of brain and spine (plus gadolinium) must have measurable contrast enhancing disease unless CSF cytology is positive
PATIENT CHARACTERISTICS:
- Karnofsky performance score 50-100%
- HIV negative
- Creatinine clearance ≥ 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- No concurrent salicylates, nonsteroidal anti-inflammatory drugs, sulfonamides, or penicillins within the past week
About this study
Official title: Intensive Chemotherapy and Immunotherapy in Patients With Newly Diagnosed Primary CNS Lymphoma: A Pilot Study
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving rituximab together with combination chemotherapy may kill more cancer cells.
PURPOSE: This clinical trial is studying the side effects and best ways to give combination chemotherapy together with rituximab in treating patients with newly diagnosed primary CNS lymphoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the rate of toxicity, in terms of percentage of patients with grade 4 neurotoxicity, in patients with untreated primary CNS lymphoma treated with induction therapy comprising high-dose methotrexate, leucovorin calcium, rituximab, and temozolomide followed by consolidation therapy comprising cytarabine and etoposide phosphate.
Secondary
- Determine the efficacy of this regimen, in terms of the 4-month and 12-month complete and best response rate, in these patients.
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the percentage of patients experiencing toxicity or neurotoxicity due to this regimen.
- Determine the treatment-related mortality rate in patients treated with this regimen.
- Document the neurocognitive changes in these patients using the Mini-Mental Status Examination during the first year of treatment with this regimen.
OUTLINE: This is a pilot, multicenter study.
- Induction therapy: Patients receive high-dose methotrexate IV over 4 hours on days 1,15, 29, 43, 57, 71, and 99; leucovorin calcium IV every 6 hours on days 2-4, 16-18, 30-32, 44-46, 58-60, 72-74, and 100-102; oral temozolomide on days 7-11, 35-39, 63-67, 91-95, and 119-123; and rituximab IV on days 3, 17, 31, 45, 59, and 74. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response proceed to consolidation therapy.
- Consolidation therapy I: Beginning 3-4 weeks after completing induction therapy, patients receive high-dose methotrexate IV over 4 hours on day 1, leucovorin calcium IV every 6 hours on days 2-4, and oral temozolomide on days 7-11.
- Consolidation therapy II: Beginning 3-5 weeks after completing consolidation therapy I, patients receive cytarabine IV over 2 hours twice daily and etoposide phosphate IV continuously on days 1-4 and filgrastim (G-CSF) subcutaneously beginning on day 14 and continuing until blood counts recover.
After completion of study treatment, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 10 patients will be accrued to this study.
- Conditions
- Brain and Central Nervous System Tumors, Lymphoma
- Being tested
- filgrastim, rituximab, cytarabine, etoposide phosphate, leucovorin calcium
- Keywords
- primary central nervous system non-Hodgkin lymphoma, primary central nervous system Hodgkin lymphoma
- Medical subject headings
- Central Nervous System Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
rituximabBiological
cytarabineDrug
etoposide phosphateDrug
methotrexateDrug
temozolomideDrug
| Study group | Role | What they receive |
|---|---|---|
| methotrexate, leucovorin calcium, rituximab, and temozolomide | Experimental | Determine the rate of toxicity, in terms of percentage of patients with grade 4 neurotoxicity, in patients with untreated primary CNS lymphoma treated with induction therapy comprising high-dose methotrexate, leucovorin calcium, rituximab, and temozolomide followed by consolidation therapy comprising cytarabine and etoposide phosphate. Receives: Biological: filgrastim; Biological: rituximab; Drug: cytarabine; Drug: etoposide phosphate; Drug: leucovorin calcium; Drug: methotrexate; Drug: temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of toxicity in patients with untreated primary CNS lymphoma
Determine the rate of toxicity, in terms of percentage of patients with grade 4 neurotoxicity, in patients with untreated primary CNS lymphoma treated with induction therapy comprising high-dose methotrexate, leucovorin calcium, rituximab, and temozolomide followed by consolidation therapy comprising cytarabine and etoposide phosphate.
Measured: up to 8 months
Secondary outcomes (1)
Efficacy in patients with untreated primary CNS lymphoma treated with induction therapy comprising high-dose methotrexate, leucovorin calcium, rituximab, and temozolomide followed by consolidation therapy comprising cytarabine and etoposide phosphate.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
- Study startSep 2003
- Primary completionDec 2005
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- James L. Rubenstein, MD, PhD, Study chair, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416819
- Sponsor's protocol ID
- CDR0000458052
- Other IDs
- UCSF-03301, UCSF-H9414-23160-02A
- Status last verified
- Aug 2015
- First submitted
- 27 Dec 2006
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wieduwilt MJ, Valles F, Issa S, Behler CM, Hwang J, McDermott M, Treseler P, O'Brien J, Shuman MA, Cha S, Damon LE, Rubenstein JL. Immunochemotherapy with intensive consolidation for primary CNS lymphoma: a pilot study and prognostic assessment by diffusion-weighted MRI. Clin Cancer Res. 2012 Feb 15;18(4):1146-55. doi: 10.1158/1078-0432.CCR-11-0625. Epub 2012 Jan 6.
PubMed 22228634
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Chemotherapy and Immunotherapy in Patients With Newly Diagnosed Primary CNS Lymphoma: A Pilot Study
- ClinicalTrials.gov ID
- NCT00416819
- Acronym / sponsor ID
- CDR0000458052
- Conditions
- Brain and Central Nervous System Tumors, Lymphoma
- Keywords
- primary central nervous system non-Hodgkin lymphoma, primary central nervous system Hodgkin lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2003
- Primary completion
- Dec 2005 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 28 Dec 2006 (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: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving rituximab together with combination chemotherapy may kill more cancer cells.
PURPOSE: This clinical trial is studying the side effects and best ways to give combination chemotherapy together with rituximab in treating patients with newly diagnosed primary CNS lymphoma.
Detailed description
OBJECTIVES:
Primary
- Determine the rate of toxicity, in terms of percentage of patients with grade 4 neurotoxicity, in patients with untreated primary CNS lymphoma treated with induction therapy comprising high-dose methotrexate, leucovorin calcium, rituximab, and temozolomide followed by consolidation therapy comprising cytarabine and etoposide phosphate.
Secondary
- Determine the efficacy of this regimen, in terms of the 4-month and 12-month complete and best response rate, in these patients.
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the percentage of patients experiencing toxicity or neurotoxicity due to this regimen.
- Determine the treatment-related mortality rate in patients treated with this regimen.
- Document the neurocognitive changes in these patients using the Mini-Mental Status Examination during the first year of treatment with this regimen.
OUTLINE: This is a pilot, multicenter study.
- Induction therapy: Patients receive high-dose methotrexate IV over 4 hours on days 1,15, 29, 43, 57, 71, and 99; leucovorin calcium IV every 6 hours on days 2-4, 16-18, 30-32, 44-46, 58-60, 72-74, and 100-102; oral temozolomide on days 7-11, 35-39, 63-67, 91-95, and 119-123; and rituximab IV on days 3, 17, 31, 45, 59, and 74. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response proceed to consolidation therapy.
- Consolidation therapy I: Beginning 3-4 weeks after completing induction therapy, patients receive high-dose methotrexate IV over 4 hours on day 1, leucovorin calcium IV every 6 hours on days 2-4, and oral temozolomide on days 7-11.
- Consolidation therapy II: Beginning 3-5 weeks after completing consolidation therapy I, patients receive cytarabine IV over 2 hours twice daily and etoposide phosphate IV continuously on days 1-4 and filgrastim (G-CSF) subcutaneously beginning on day 14 and continuing until blood counts recover.
After completion of study treatment, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 10 patients will be accrued to this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| methotrexate, leucovorin calcium, rituximab, and temozolomide | Experimental | Biological: filgrastim, Biological: rituximab, Drug: cytarabine, Drug: etoposide phosphate, Drug: leucovorin calcium, Drug: methotrexate, Drug: temozolomideDetermine the rate of toxicity, in terms of percentage of patients with grade 4 neurotoxicity, in patients with untreated primary CNS lymphoma treated with induction therapy comprising high-dose methotrexate, leucovorin calcium, rituximab, and temozolomide followed by consolidation therapy comprising cytarabine and etoposide phosphate. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| filgrastim | Biological | methotrexate, leucovorin calcium, rituximab, and temozolomide |
| rituximab | Biological | methotrexate, leucovorin calcium, rituximab, and temozolomide |
| cytarabine | Drug | methotrexate, leucovorin calcium, rituximab, and temozolomide |
| etoposide phosphate | Drug | methotrexate, leucovorin calcium, rituximab, and temozolomide |
| leucovorin calcium | Drug | methotrexate, leucovorin calcium, rituximab, and temozolomide |
| methotrexate | Drug | methotrexate, leucovorin calcium, rituximab, and temozolomide |
| temozolomide | Drug | methotrexate, leucovorin calcium, rituximab, and temozolomide |
Primary outcome
rate of toxicity in patients with untreated primary CNS lymphoma
Time frame: up to 8 months
Determine the rate of toxicity, in terms of percentage of patients with grade 4 neurotoxicity, in patients with untreated primary CNS lymphoma treated with induction therapy comprising high-dose methotrexate, leucovorin calcium, rituximab, and temozolomide followed by consolidation therapy comprising cytarabine and etoposide phosphate.
1 secondary outcome
Efficacy in patients with untreated primary CNS lymphoma treated with induction therapy comprising high-dose methotrexate, leucovorin calcium, rituximab, and temozolomide followed by consolidation therapy comprising cytarabine and etoposide phosphate.
Time frame: up to 12 months
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 20 Aug 2015.
- Results publication: PubMed 22228634Wieduwilt MJ, Valles F, Issa S, Behler CM, Hwang J, McDermott M, Treseler P, O'Brien J, Shuman MA, Cha S, Damon LE, Rubenstein JL. Immunochemotherapy with intensive consolidation for primary CNS lymphoma: a pilot study and prognostic assessment by diffusion-weighted MRI. Clin Cancer Res. 2012 Feb 15;18(4):1146-55. doi: 10.1158/1078-0432.CCR-11-0625. Epub 2012 Jan 6.
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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.
James L. Rubenstein, MD, PhD study chair
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing filgrastim, rituximab and cytarabine in people with Brain and Central Nervous System Tumors and Lymphoma, run by University of California, San Francisco.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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.
What does the primary outcome measure?
rate of toxicity in patients with untreated primary CNS lymphoma (time frame: up to 8 months). 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 NCT00416819, 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 20 Aug 2015.