LymphomaPhase 2Protocol-ANCT00074191
Methotrexate, Procarbazine, Lomustine, Dexamethasone, and Cytarabine in Treating Patients With Primary CNS Lymphoma
A Phase 2 study testing cytarabine, dexamethasone and lomustine in people with Lymphoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as methotrexate, procarbazine, lomustine, dexamethasone, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- cytarabine, dexamethasone and lomustine
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to Oct 2000
- Phase
- Phase 2
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed intermediate- or high-grade primary CNS lymphoma documented by brain biopsy or cerebrospinal fluid or vitrectomy analysis
- Diagnosed within the past 90 days
- No systemic lymphoma NOTE: 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
- 16 to 75
Performance status
- ECOG 0-3 OR
- Karnofsky 40-100%
Life expectancy
- Not specified
Hematopoietic
- WBC at least 2,500/mm^3
- Hematocrit at least 25% (transfusion allowed)
- Absolute granulocyte count at least 1,200/mm^3
- Platelet count at least 100,000/mm^3 OR at least lower limit of normal (transfusion independent)
Hepatic
- Bilirubin no greater than 2.0 times upper limit of normal
Renal
- Creatinine clearance at least 30 mL/min
Cardiovascular
- Adequate cardiac function to tolerate general anesthesia
Pulmonary
- Adequate pulmonary function to tolerate general anesthesia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for 2 months before and during study participation
- No other uncontrolled, clinically significant confounding medical condition within the past 30 days
- No known allergy to study agents
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- Single-agent methotrexate administered within the past 14 days allowed
Endocrine therapy
- Not specified
Radiotherapy
- No prior cranial or spinal radiotherapy
Surgery
- Prior surgery or biopsy allowed
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University Cancer Institute
Portland, Oregon, 97239-3098
About this study
Official title: Combination Chemotherapy (Methotrexate, Procarbazine And CCNU), Intraventricular Cytarabine And Methotrexate, +/- Intra-Ocular Chemotherapy For Patients With Primary Central Nervous System Lymphoma
RATIONALE: Drugs used in chemotherapy, such as methotrexate, procarbazine, lomustine, dexamethasone, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have primary CNS lymphoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the toxicity and efficacy of methotrexate, procarbazine, lomustine, dexamethasone, and cytarabine in patients with primary CNS lymphoma.
Secondary
- Determine the ability to recruit adequate numbers of patients for this study.
- Compare progression-free and dementia-free survival with standard measures of overall survival, progression-free survival, disease-free survival, complete response rate, cognitive function, and quality of life of patients treated with this regimen.
- Determine the feasibility of conducting a future phase III study of this treatment regimen in these patients.
- Correlate neuropsychological outcomes with neuroimaging (MRI) outcomes in patients treated with this regimen.
OUTLINE: This is a nonrandomized, multicenter study.
- Induction chemotherapy: Patients receive methotrexate IV over 3 hours on days 1, 10, and 20 and intraventricularly or intrathecally (IT) over 5 minutes on days 1, 5, 10, and 15; oral procarbazine on days 1-7; oral lomustine on day 1; oral dexamethasone every 6 hours on days 1-14 followed by a taper (as tolerated); and cytarabine intraventricularly or IT over 5 minutes on days 1, 5, 10, and 15. Treatment repeats every 42 days for a total of 3 courses. Patients with intraocular lymphoma also receive methotrexate intravitreally twice weekly until the vitreous is clear of cells by slit lamp exam. Patients with stable or responding disease proceed to maintenance therapy.
- Maintenance chemotherapy: Patients receive methotrexate IV over 3 hours and IT over 5 minutes on day 1; oral procarbazine on days 1-7; oral lomustine on day 1; oral dexamethasone every 6 hours on days 1-14 followed by a taper (as tolerated); and cytarabine intraventricularly or IT over 5 minutes on day 1. Treatment repeats every 42 days for a total of 5 courses.
Patients with intraocular lymphoma also receive methotrexate intravitreally weekly for 1 month and then monthly for 1 year.
Quality of life is assessed at baseline, at 6 months, at the completion of treatment, every 6 months for 2 years, and then annually thereafter.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study within 3 years.
- Conditions
- Lymphoma
- Being tested
- cytarabine, dexamethasone, lomustine, methotrexate, procarbazine hydrochloride
- Keywords
- intraocular lymphoma, primary central nervous system lymphoma
- Medical subject headings
- Lymphoma, Intraocular Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytarabineDrug
dexamethasoneDrug
lomustineDrug
methotrexateDrug
procarbazine hydrochlorideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival as measured by clinical and radiographic response at 5 years following completion of study treatment
Measured: 5 years
Secondary outcomes (3)
Overall survival as measured by clinical and radiographic response
Measured: 5 years
Progression-free survival as measured by clinical and radiographic response until tumor progression
Measured: 5 years
Quality of Life (QOL) as measured by EORTC QOL before and after study treatment, every 6 months for 2 years, and then annually
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2003 (estimated)
- Study startJan 2000
- Primary completionOct 2000
- Study completionOct 2000
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 OHSU Knight Cancer InstituteThe 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
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Edward Neuwelt, OHSU Knight Cancer Institute
- Investigators
- Edward A. Neuwelt, MD, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00074191
- Sponsor's protocol ID
- IRB00000929
- Other IDs
- 5729-1, ONC-99054-1, 929, OHSU-5729-1
- Acronym
- Protocol-A
- Status last verified
- Apr 2017
- First submitted
- 10 Dec 2003
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Chemotherapy (Methotrexate, Procarbazine And CCNU), Intraventricular Cytarabine And Methotrexate, +/- Intra-Ocular Chemotherapy For Patients With Primary Central Nervous System Lymphoma
- ClinicalTrials.gov ID
- NCT00074191
- Acronym / sponsor ID
- Protocol-A / IRB00000929
- Conditions
- Lymphoma
- Keywords
- intraocular lymphoma, primary central nervous system lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2000
- Primary completion
- Oct 2000 (actual)
- Study completion
- Oct 2000 (actual)
- First posted
- 11 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: Drugs used in chemotherapy, such as methotrexate, procarbazine, lomustine, dexamethasone, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have primary CNS lymphoma.
Detailed description
OBJECTIVES:
Primary
- Determine the toxicity and efficacy of methotrexate, procarbazine, lomustine, dexamethasone, and cytarabine in patients with primary CNS lymphoma.
Secondary
- Determine the ability to recruit adequate numbers of patients for this study.
- Compare progression-free and dementia-free survival with standard measures of overall survival, progression-free survival, disease-free survival, complete response rate, cognitive function, and quality of life of patients treated with this regimen.
- Determine the feasibility of conducting a future phase III study of this treatment regimen in these patients.
- Correlate neuropsychological outcomes with neuroimaging (MRI) outcomes in patients treated with this regimen.
OUTLINE: This is a nonrandomized, multicenter study.
- Induction chemotherapy: Patients receive methotrexate IV over 3 hours on days 1, 10, and 20 and intraventricularly or intrathecally (IT) over 5 minutes on days 1, 5, 10, and 15; oral procarbazine on days 1-7; oral lomustine on day 1; oral dexamethasone every 6 hours on days 1-14 followed by a taper (as tolerated); and cytarabine intraventricularly or IT over 5 minutes on days 1, 5, 10, and 15. Treatment repeats every 42 days for a total of 3 courses. Patients with intraocular lymphoma also receive methotrexate intravitreally twice weekly until the vitreous is clear of cells by slit lamp exam. Patients with stable or responding disease proceed to maintenance therapy.
- Maintenance chemotherapy: Patients receive methotrexate IV over 3 hours and IT over 5 minutes on day 1; oral procarbazine on days 1-7; oral lomustine on day 1; oral dexamethasone every 6 hours on days 1-14 followed by a taper (as tolerated); and cytarabine intraventricularly or IT over 5 minutes on day 1. Treatment repeats every 42 days for a total of 5 courses.
Patients with intraocular lymphoma also receive methotrexate intravitreally weekly for 1 month and then monthly for 1 year.
Quality of life is assessed at baseline, at 6 months, at the completion of treatment, every 6 months for 2 years, and then annually thereafter.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study within 3 years.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 75 years
- 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 |
|---|---|---|
| cytarabine | Drug | – |
| dexamethasone | Drug | – |
| lomustine | Drug | – |
| methotrexate | Drug | – |
| procarbazine hydrochloride | Drug | – |
Primary outcome
Survival as measured by clinical and radiographic response at 5 years following completion of study treatment
Time frame: 5 years
3 secondary outcomes
Overall survival as measured by clinical and radiographic response
Time frame: 5 years
Progression-free survival as measured by clinical and radiographic response until tumor progression
Time frame: 5 years
Quality of Life (QOL) as measured by EORTC QOL before and after study treatment, every 6 months for 2 years, and then annually
Time frame: 5 years
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 21 Apr 2017.
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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.
Edward A. Neuwelt, MD principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cytarabine, dexamethasone and lomustine in people with Lymphoma, run by OHSU Knight Cancer Institute 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: finished, as of the sponsor's last update on 21 Apr 2017. 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 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?
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?
Survival as measured by clinical and radiographic response at 5 years following completion of study treatment (time frame: 5 years). 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 21 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.