Brain and Central Nervous System TumorsPhase 1/2NCT00068250
Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
A Phase 1/2 study testing rituximab, methotrexate and temozolomide 100 mg/m^2 in people with Brain and Central Nervous System Tumors and Lymphoma, run by Radiation Therapy Oncology Group at 26 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy such as methotrexate and temozolomide use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors, Lymphoma
- What is being tested?
- rituximab, methotrexate and temozolomide 100 mg/m^2
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 26 sitesUnited States
- Study dates
- Jul 2003to Dec 2016
- Phase
- Phase 1/2
- 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
Who may be able to join
- Primary central nervous system (CNS) lymphoma [B-cell, Cluster of Differentiation 20 (CD20) antigen positive] based on positive biopsy or cerebrospinal fluid (CSF) or vitreous cytology (in association with measurable intraparenchymal tumor). Cytology must demonstrate lymphoma or have an immunohistochemical diagnosis of malignant lymphocytes with a monoclonal lymphocytic population.
- Life expectancy ≥ 8 weeks;
- Zubrod performance status of 0-2;
- Absolute granulocyte count ≥1500/mm3; platelet count ≥ 100,000/mm3; creatinine clearance ≥ 50, calculated with the Cockcroft-Gault Equation: Cr Clearance = (140-age) x wt (kg)/(Cr[mg/dl]x 72); Bilirubin, serum glutamate oxaloacetate transaminase (SGOT), alkaline phosphatase (AST) ≤ 2 x institutional upper limits of normal;
- Patients must sign a study-specific informed consent prior to study entry.
- Age ≥ 18
Who cannot join
- Evidence of systemic lymphoma;
- Prior malignancy (excluding in situ carcinoma of the cervix or non-melanomatous skin cancer)unless disease free for at least five years;
- Prior radiotherapy to the brain or head/neck;
- Prior chemotherapy;
- History of idiopathic sensitivity to any of the drugs to be used;
- Active infectious process;
Show all 9Show fewer
- Seropositive for HIV, AIDS, or post-organ transplant;
- Pregnant women are ineligible as treatment involves unforeseeable risks to the participant and to the embryo or fetus.
- Active hepatitis B.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
John F. Kennedy Medical Center
Edison, New Jersey, 08818
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, 32207
Integrated Community Oncology Network at Southside Cancer Center
Jacksonville, Florida, 32207
Baptist Medical Center South
Jacksonville, Florida, 32258
Integrated Community Oncology Network
Jacksonville Beach, Florida, 32250
Borgess Medical Center
Kalamazoo, Michigan, 49001
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
CCOP - Kansas City
Kansas City, Missouri, 64131
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Community Memorial Hospital Cancer Care Center
Menomonee Falls, Wisconsin, 53051
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
Providence Milwaukie Hospital
Milwaukie, Oregon, 97222
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, 84157
Integrated Community Oncology Network - Orange Park
Orange Park, Florida, 32073
Florida Cancer Center - Palatka
Palatka, Florida, 32177
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, 97213-2967
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84604
Flagler Cancer Center
Saint Augustine, Florida, 32086
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, 98668
About this study
Official title: Phase I/II Study Of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, And Temozolomide And Post -Irradiation Temozolomide For Primary Central Nervous System Lymphoma
RATIONALE: Drugs used in chemotherapy such as methotrexate and temozolomide use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining methotrexate, temozolomide, and rituximab with radiation therapy may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of temozolomide when given together with methotrexate and rituximab followed by radiation therapy and to see how well they work in treating patients with primary central nervous system lymphoma.
Read the detailed description
OBJECTIVES:
- To assess the maximum tolerated dose (MTD) of temozolomide (TMZ) in combination with methotrexate (MTX) and rituximab (RTX) when administered prior to twice daily fractionated whole brain radiation therapy (WBRT) in patients with primary central nervous system lymphoma.
- To compare the two-year survival rate in patients receiving pre-irradiation chemotherapy, twice daily fractionated whole brain radiation therapy and post-irradiation temozolomide to the reported two-year survival rate of Radiation Therapy Oncology Group (RTOG) trial 93-10. RTOG 9310 does not fall within ClinicalTrials.gov registration/reporting requirements.)
- To compare the pre-irradiation chemotherapy tumor response rates to the reported rate from RTOG 93-10.
- To report progression-free survival.
- To assess acute and long-term neurologic toxicity, and to collect quality of life data for this patient group.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
- Conditions
- Brain and Central Nervous System Tumors, Lymphoma
- Being tested
- rituximab, methotrexate, temozolomide 100 mg/m^2, temozolomide 150 mg/m^2, temozolomide 200 mg/m^2
- 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.
rituximabDrug
375 mg/m2, intravenously three days prior to the first cycle of methotrexate
methotrexateDrug
Five cycles of methotrexate (MTX) at 3.5 gm/m2 administered every two weeks on weeks 1, 3, 5, 7, and 9 via intravenous infusion over four hours once per cycle. Calcium leucovorin 25 mg orally or intravenously every six hours initiated exactly 24 hours following the start of the MTX infusion. Methotrexate levels to be monitored daily, and calcium leucovorin discontinued when the MTX level is less than 10 micromolar.
temozolomide 100 mg/m^2Drug
Temozolomide 100 mg/m^2 by mouth per day for five days on weeks 4 and 8.
temozolomide 150 mg/m^2Drug
Temozolomide 150 mg/m^2 by mouth per day for five days on weeks 4 and 8.
temozolomide 200 mg/m^2Drug
Temozolomide 200 mg/m^2 per day by mouth for five days on weeks 4 and 8.
radiation therapyRadiation
Also called radiotherapy
Whole brain irradiation (WBRT) during weeks 11, 12, and 13, five days per week (excluding weekends). A daily dose of 2.4 Gy delivered in two fractions of 1.2 Gy each with a minimum inter-fraction interval of 6 hours, with a total dose to brain and meninges of 36 Gy.
post-radiation therapy temozolomideDrug
Temozolomide (TMZ) 200 mg/m^2 by mouth per day for 5 days on weeks 14, 18, 22, 26, 30, 34, 38, 42, 46, and 50 for a total of 10 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Temozolomide 100 mg | Experimental | Rituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2. Receives: Drug: rituximab; Drug: methotrexate; Drug: temozolomide 100 mg/m^2; Radiation: radiation therapy; Drug: post-radiation therapy temozolomide |
| Phase I: Temozolomide 150 mg | Experimental | Rituximab, methotrexate, temozolomide 150 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2. Receives: Drug: rituximab; Drug: methotrexate; Drug: temozolomide 150 mg/m^2; Radiation: radiation therapy; Drug: post-radiation therapy temozolomide |
| Phase I: Temozolomide 200 mg | Experimental | Rituximab, methotrexate, temozolomide 200 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2. Receives: Drug: rituximab; Drug: methotrexate; Drug: temozolomide 200 mg/m^2; Radiation: radiation therapy; Drug: post-radiation therapy temozolomide |
| Phase II: Temozolomide 100 mg | Experimental | Rituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2. Receives: Drug: rituximab; Drug: methotrexate; Drug: temozolomide 100 mg/m^2; Radiation: radiation therapy; Drug: post-radiation therapy temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Phase I Participants Experiencing Toxicity
A dose limiting toxicity (DLT) is defined as any grade 3 or 4 non-hematological toxicity (other than grade 3 nausea/vomiting) or any hematological toxicity resulting in the discontinuation of temozolomide. Toxicity evaluation for this dose escalation includes all toxicities occurring prior to the start of radiation therapy. If the patient did not receive radiation therapy, then toxicity evaluation included all toxicities occurring through week 15. Any grade 5 toxicity would result in immediate suspension of accrual.
Measured: From start of treatment to 10 weeks if radiation therapy received, to 15 weeks if not.
Phase II: Overall Survival Rate at 2 Years (Including Phase I Patients at Same Dose)
Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. (Please note that this outcome measure is considered the primary endpoint for the Phase II component of the study, but that the patients from Phase I that were treated at the same dose level are included, as indicated in the treatment arm descriptions. )
Measured: Analysis occured after all patients have been on study for 2 years. Maximum follow-up at time of analysis was 8.5 years.
Secondary outcomes (2)
Phase II: Pre-irradiation Chemotherapy Tumor Response Rate (Including Phase I Patients at Same Dose)
Tumor response was centrally reviewed. Complete response: Disappearance of all enhancing tumor, the patient must be off steroid therapy and neurologically stable or improved; partial response: ≥ 50% decrease in enhancing tumor; progressive disease: ≥ 25% increase in a lesion, progressive or newly emergent meningeal or ocular disease. (Please note that this outcome measure is considered a secondary endpoint for the Phase II component of the study, but that the patients from Phase I that were treated at the same dose level are included, as indicated in the treatment arm descriptions. )
Measured: From start of treatment to 10 weeks if RT received, to 15 weeks if not.
Phase II: Progression-free Survival (Including Phase I Patients at Same Dose)
Progression is defined as greater than 25% increase in enhancing tumor or the appearance of new lesions in the brain, eye, or the appearance of a new positive cerebrospinal fluid (CSF) cytology. The patient may be neurologically stable or worse and on stable or increasing doses of corticosteroid. Progression-free survival time is defined as time from registration to the date of progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. (Please note that this outcome measure is considered a secondary endpoint for the Phase II component of the study, but that the patients from Phase I that were treated at the same dose level are included, as indicated in the treatment arm descriptions. )
Measured: Analysis occured after all patients have been on study for 2 years. Maximum follow-up at time of analysis was 8.5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2003 (estimated)
- Study startJul 2003
- Primary completionDec 2016
- Study completionDec 2016
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 Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiation Therapy Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), NRG Oncology
- Responsible party
- Sponsor
- Investigators
- Jon Glass, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00068250
- Sponsor's protocol ID
- RTOG-0227
- Other IDs
- CDR0000301563
- Status last verified
- Feb 2018
- First submitted
- 10 Sep 2003
- Last updated
- 7 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Glass J, Won M, Schultz CJ, Brat D, Bartlett NL, Suh JH, Werner-Wasik M, Fisher BJ, Liepman MK, Augspurger M, Bokstein F, Bovi JA, Solhjem MC, Mehta MP. Phase I and II Study of Induction Chemotherapy With Methotrexate, Rituximab, and Temozolomide, Followed By Whole-Brain Radiotherapy and Postirradiation Temozolomide for Primary CNS Lymphoma: NRG Oncology RTOG 0227. J Clin Oncol. 2016 May 10;34(14):1620-5. doi: 10.1200/JCO.2015.64.8634. Epub 2016 Mar 28.
PubMed 27022122
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study Of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, And Temozolomide And Post -Irradiation Temozolomide For Primary Central Nervous System Lymphoma
- ClinicalTrials.gov ID
- NCT00068250
- Acronym / sponsor ID
- RTOG-0227
- Conditions
- Brain and Central Nervous System Tumors, Lymphoma
- Keywords
- primary central nervous system non-Hodgkin lymphoma, primary central nervous system Hodgkin lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Radiation Therapy Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI), NRG Oncology
- Study start
- Jul 2003
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Sep 2003 (estimated)
- Results
- Posted 7 Feb 2018
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 and temozolomide use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining methotrexate, temozolomide, and rituximab with radiation therapy may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of temozolomide when given together with methotrexate and rituximab followed by radiation therapy and to see how well they work in treating patients with primary central nervous system lymphoma.
Detailed description
OBJECTIVES:
- To assess the maximum tolerated dose (MTD) of temozolomide (TMZ) in combination with methotrexate (MTX) and rituximab (RTX) when administered prior to twice daily fractionated whole brain radiation therapy (WBRT) in patients with primary central nervous system lymphoma.
- To compare the two-year survival rate in patients receiving pre-irradiation chemotherapy, twice daily fractionated whole brain radiation therapy and post-irradiation temozolomide to the reported two-year survival rate of Radiation Therapy Oncology Group (RTOG) trial 93-10. RTOG 9310 does not fall within ClinicalTrials.gov registration/reporting requirements.)
- To compare the pre-irradiation chemotherapy tumor response rates to the reported rate from RTOG 93-10.
- To report progression-free survival.
- To assess acute and long-term neurologic toxicity, and to collect quality of life data for this patient group.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase I: Temozolomide 100 mg | Experimental | Drug: rituximab, Drug: methotrexate, Drug: temozolomide 100 mg/m^2, Radiation: radiation therapy, Drug: post-radiation therapy temozolomideRituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2. |
| Phase I: Temozolomide 150 mg | Experimental | Drug: rituximab, Drug: methotrexate, Drug: temozolomide 150 mg/m^2, Radiation: radiation therapy, Drug: post-radiation therapy temozolomideRituximab, methotrexate, temozolomide 150 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2. |
| Phase I: Temozolomide 200 mg | Experimental | Drug: rituximab, Drug: methotrexate, Drug: temozolomide 200 mg/m^2, Radiation: radiation therapy, Drug: post-radiation therapy temozolomideRituximab, methotrexate, temozolomide 200 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2. |
| Phase II: Temozolomide 100 mg | Experimental | Drug: rituximab, Drug: methotrexate, Drug: temozolomide 100 mg/m^2, Radiation: radiation therapy, Drug: post-radiation therapy temozolomideRituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary central nervous system (CNS) lymphoma [B-cell, Cluster of Differentiation 20 (CD20) antigen positive] based on positive biopsy or cerebrospinal fluid (CSF) or vitreous cytology (in association with measurable intraparenchymal tumor). Cytology must demonstrate lymphoma or have an immunohistochemical diagnosis of malignant lymphocytes with a monoclonal lymphocytic population.
- Life expectancy ≥ 8 weeks;
- Zubrod performance status of 0-2;
- Absolute granulocyte count ≥1500/mm3; platelet count ≥ 100,000/mm3; creatinine clearance ≥ 50, calculated with the Cockcroft-Gault Equation: Cr Clearance = (140-age) x wt (kg)/(Cr[mg/dl]x 72); Bilirubin, serum glutamate oxaloacetate transaminase (SGOT), alkaline phosphatase (AST) ≤ 2 x institutional upper limits of normal;
- Patients must sign a study-specific informed consent prior to study entry.
Key exclusion criteria (9 listed)
- Evidence of systemic lymphoma;
- Prior malignancy (excluding in situ carcinoma of the cervix or non-melanomatous skin cancer)unless disease free for at least five years;
- Prior radiotherapy to the brain or head/neck;
- Prior chemotherapy;
- History of idiopathic sensitivity to any of the drugs to be used;
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 |
|---|---|---|
| rituximab375 mg/m2, intravenously three days prior to the first cycle of methotrexate | Drug | Phase I: Temozolomide 100 mg, Phase I: Temozolomide 150 mg, Phase I: Temozolomide 200 mg, Phase II: Temozolomide 100 mg |
| methotrexateFive cycles of methotrexate (MTX) at 3.5 gm/m2 administered every two weeks on weeks 1, 3, 5, 7, and 9 via intravenous infusion over four hours once per cycle. Calcium leucovorin 25 mg orally or intravenously every six hours initiated exactly 24 hours following the start of the MTX infusion. Methotrexate levels to be monitored daily, and calcium leucovorin discontinued when the MTX level is less than 10 micromolar. | Drug | Phase I: Temozolomide 100 mg, Phase I: Temozolomide 150 mg, Phase I: Temozolomide 200 mg, Phase II: Temozolomide 100 mg |
| temozolomide 100 mg/m^2Temozolomide 100 mg/m^2 by mouth per day for five days on weeks 4 and 8. | Drug | Phase I: Temozolomide 100 mg, Phase II: Temozolomide 100 mg |
| temozolomide 150 mg/m^2Temozolomide 150 mg/m^2 by mouth per day for five days on weeks 4 and 8. | Drug | Phase I: Temozolomide 150 mg |
| temozolomide 200 mg/m^2Temozolomide 200 mg/m^2 per day by mouth for five days on weeks 4 and 8. | Drug | Phase I: Temozolomide 200 mg |
| radiation therapyAlso: radiotherapyWhole brain irradiation (WBRT) during weeks 11, 12, and 13, five days per week (excluding weekends). A daily dose of 2.4 Gy delivered in two fractions of 1.2 Gy each with a minimum inter-fraction interval of 6 hours, with a total dose to brain and meninges of 36 Gy. | Radiation | Phase I: Temozolomide 100 mg, Phase I: Temozolomide 150 mg, Phase I: Temozolomide 200 mg, Phase II: Temozolomide 100 mg |
| post-radiation therapy temozolomideTemozolomide (TMZ) 200 mg/m^2 by mouth per day for 5 days on weeks 14, 18, 22, 26, 30, 34, 38, 42, 46, and 50 for a total of 10 cycles. | Drug | Phase I: Temozolomide 100 mg, Phase I: Temozolomide 150 mg, Phase I: Temozolomide 200 mg, Phase II: Temozolomide 100 mg |
Primary outcome
Number of Phase I Participants Experiencing Toxicity
Time frame: From start of treatment to 10 weeks if radiation therapy received, to 15 weeks if not.
A dose limiting toxicity (DLT) is defined as any grade 3 or 4 non-hematological toxicity (other than grade 3 nausea/vomiting) or any hematological toxicity resulting in the discontinuation of temozolomide. Toxicity evaluation for this dose escalation includes all toxicities occurring prior to the start of radiation therapy. If the patient did not receive radiation therapy, then toxicity evaluation included all toxicities occurring through week 15. Any grade 5 toxicity would result in immediate suspension of accrual.
Phase II: Overall Survival Rate at 2 Years (Including Phase I Patients at Same Dose)
Time frame: Analysis occured after all patients have been on study for 2 years. Maximum follow-up at time of analysis was 8.5 years.
Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. (Please note that this outcome measure is considered the primary endpoint for the Phase II component of the study, but that the patients from Phase I that were treated at the same dose level are included, as indicated in the treatment arm descriptions. )
2 secondary outcomes
Phase II: Pre-irradiation Chemotherapy Tumor Response Rate (Including Phase I Patients at Same Dose)
Time frame: From start of treatment to 10 weeks if RT received, to 15 weeks if not.
Phase II: Progression-free Survival (Including Phase I Patients at Same Dose)
Time frame: Analysis occured after all patients have been on study for 2 years. Maximum follow-up at time of analysis was 8.5 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27022122Glass J, Won M, Schultz CJ, Brat D, Bartlett NL, Suh JH, Werner-Wasik M, Fisher BJ, Liepman MK, Augspurger M, Bokstein F, Bovi JA, Solhjem MC, Mehta MP. Phase I and II Study of Induction Chemotherapy With Methotrexate, Rituximab, and Temozolomide, Followed By Whole-Brain Radiotherapy and Postirradiation Temozolomide for Primary CNS Lymphoma: NRG Oncology RTOG 0227. J Clin Oncol. 2016 May 10;34(14):1620-5. doi: 10.1200/JCO.2015.64.8634. Epub 2016 Mar 28.
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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.
Jon Glass, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing rituximab, methotrexate and temozolomide 100 mg/m^2 in people with Brain and Central Nervous System Tumors and Lymphoma, run by Radiation Therapy Oncology Group at 26 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?
The sponsor lists 6 inclusion and 9 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 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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 combined 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.
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 7 Feb 2018). 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?
Number of Phase I Participants Experiencing Toxicity (time frame: From start of treatment to 10 weeks if radiation therapy received, to 15 weeks if not.). The study lists 2 primary outcomes in all. 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 NCT00068250, 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 7 Feb 2018.