LymphomaPhase 2CNSLymphomaNCT00503594
Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine
A Phase 2 study testing Methotrexate and temozolomide and Methotrexate , procarbazine ,vincristine ,cytarabine in people with Lymphoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to evaluate two types of chemotherapy for primary central nervous system lymphoma in the elderly (age older than 60) : Methotrexate, procarbazine, vincristine and cytarabine Methotrexate and temozolomide Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Methotrexate and temozolomide and Methotrexate , procarbazine ,vincristine ,cytarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2007to Jul 2012
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary central nervous system lymphoma histologically confirmed by brain biopsy, CSF cytology or vitrectomy
- KPS 40 or higher
- Absence of systemic disease as evaluated by chest-abdomen-pelvis CT scan
- Leucocytes>3.500/mm3, platelets>130.000/mm3, Bilirubin < 2 mg, transaminases < 2.5 N), creatinine < 150 μM/l, creatinine clearance > 40 ml/min
- Age ≥ 60 years
- Negative HIV test
- Signature of informed consent
Who cannot join
- previous cranial radiotherapy
- prior chemotherapy for primary central nervous system lymphoma
- presence of another cancer (excepting basal cell carcinoma of the skin and cervical carcinoma in situ )
- systemic lymphoma (outside the CNS)
- Isolated ocular lymphoma
- Immunosuppressed patients (HIV , use of immunosuppressors)
Show all 10Show fewer
- Other uncontrolled or progressive disease compromising shot-term survival
- Severe renal or hepatic disease
- Patients not legally covered by the French Social Security
- Inability to swallow the medication
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Groupe hospitalier la Pitié Salpétrière
Paris, 75013
Antonio OMURO, MD,PhD, + 33(0) 1 42 16 41 60, antonio.omuro@psl.aphp.fr
About this study
Official title: Multicenter Randomized Phase II Study of Methotrexate (MTX) and Temozolomide Versus MTX, Procarbazine, Vincristine and Cytarabine for Primary CNS Lymphoma (PCNSL) in the Elderly
The purpose of this study is to evaluate two types of chemotherapy for primary central nervous system lymphoma in the elderly (age older than 60) :
- Methotrexate, procarbazine, vincristine and cytarabine
- Methotrexate and temozolomide
Read the detailed description
The aim of the study is to evaluate efficacy and toxicity associated with both protocols in this population, without radiotherapy.
Patients will be randomized to receive one of the two regimens in one of the participating centers. Neuropsychological evaluation will be performed in all patients. Patients will be followed with serial MRIs.
- Conditions
- Lymphoma
- Being tested
- Methotrexate and temozolomide, Methotrexate , procarbazine ,vincristine ,cytarabine
- Keywords
- Primary central nervous system lymphoma, Brain lymphoma, Elderly, Chemotherapy, Methotrexate, Temozolomide, Procarbazine, Vincristine, Cytarabine
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methotrexate and temozolomideDrug
Methotrexate and temozolomide
Methotrexate , procarbazine ,vincristine ,cytarabineDrug
Methotrexate , procarbazine ,vincristine ,cytarabine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Comparative evaluation of the efficiency of a new protocol of the primitive LYMPHOME of the central nervous system ( LPSNC) to the old subject, associating Methotrexate and Temozolomide with regard to a standard protocol associating Methotrexate, Procarbazine, Vincristine and Cytarabine. Receives: Drug: Methotrexate and temozolomide |
| bras conventional | Active comparator | bras conventional Receives: Drug: Methotrexate , procarbazine ,vincristine ,cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: at one year
Secondary outcomes (4)
Overall survival:median and overall survival
Measured: at one and two years
Response rates
Measured: at end of treatment
Toxicity
Measured: during treatment
Late toxicity
Measured: 2 to 5 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2010
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- French Innovative Leukemia Organisation
- Responsible party
- Sponsor
- Investigators
- Antonio OMURO, MD,, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503594
- Sponsor's protocol ID
- P060239
- Acronym
- CNSLymphoma
- Status last verified
- Jul 2007
- First submitted
- 18 Jul 2007
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Omuro AM, Abrey LE. Chemotherapy for primary central nervous system lymphoma. Neurosurg Focus. 2006 Nov 15;21(5):E12. doi: 10.3171/foc.2006.21.5.13.
PubMed 17134114Omuro A, Chinot O, Taillandier L, Ghesquieres H, Soussain C, Delwail V, Lamy T, Gressin R, Choquet S, Soubeyran P, Huchet A, Benouaich-Amiel A, Lebouvier-Sadot S, Gyan E, Touitou V, Barrie M, del Rio MS, Gonzalez-Aguilar A, Houillier C, Delgadillo D, Lacomblez L, Tanguy ML, Hoang-Xuan K. Methotrexate and temozolomide versus methotrexate, procarbazine, vincristine, and cytarabine for primary CNS lymphoma in an elderly population: an intergroup ANOCEF-GOELAMS randomised phase 2 trial. Lancet Haematol. 2015 Jun;2(6):e251-9. doi: 10.1016/S2352-3026(15)00074-5. Epub 2015 Jun 3.
PubMed 26688235
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Phase II Study of Methotrexate (MTX) and Temozolomide Versus MTX, Procarbazine, Vincristine and Cytarabine for Primary CNS Lymphoma (PCNSL) in the Elderly
- ClinicalTrials.gov ID
- NCT00503594
- Acronym / sponsor ID
- CNSLymphoma / P060239
- Conditions
- Lymphoma
- Keywords
- Primary central nervous system lymphoma, Brain lymphoma, Elderly, Chemotherapy, Methotrexate, Temozolomide, Procarbazine, Vincristine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- French Innovative Leukemia Organisation
- Study start
- Jul 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2012 (estimated)
- First posted
- 19 Jul 2007 (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.
The purpose of this study is to evaluate two types of chemotherapy for primary central nervous system lymphoma in the elderly (age older than 60) :
- Methotrexate, procarbazine, vincristine and cytarabine
- Methotrexate and temozolomide
Detailed description
The aim of the study is to evaluate efficacy and toxicity associated with both protocols in this population, without radiotherapy.
Patients will be randomized to receive one of the two regimens in one of the participating centers. Neuropsychological evaluation will be performed in all patients. Patients will be followed with serial MRIs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Methotrexate and temozolomideComparative evaluation of the efficiency of a new protocol of the primitive LYMPHOME of the central nervous system ( LPSNC) to the old subject, associating Methotrexate and Temozolomide with regard to a standard protocol associating Methotrexate, Procarbazine, Vincristine and Cytarabine. |
| bras conventional | Active comparator | Drug: Methotrexate , procarbazine ,vincristine ,cytarabinebras conventional |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- primary central nervous system lymphoma histologically confirmed by brain biopsy, CSF cytology or vitrectomy
- KPS 40 or higher
- Absence of systemic disease as evaluated by chest-abdomen-pelvis CT scan
- Leucocytes>3.500/mm3, platelets>130.000/mm3, Bilirubin < 2 mg, transaminases < 2.5 N), creatinine < 150 μM/l, creatinine clearance > 40 ml/min
- Age ≥ 60 years
Key exclusion criteria (10 listed)
- previous cranial radiotherapy
- prior chemotherapy for primary central nervous system lymphoma
- presence of another cancer (excepting basal cell carcinoma of the skin and cervical carcinoma in situ )
- systemic lymphoma (outside the CNS)
- Isolated ocular lymphoma
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 |
|---|---|---|
| Methotrexate and temozolomideMethotrexate and temozolomide | Drug | 1 |
| Methotrexate , procarbazine ,vincristine ,cytarabineMethotrexate , procarbazine ,vincristine ,cytarabine | Drug | bras conventional |
Primary outcome
Progression-free survival
Time frame: at one year
4 secondary outcomes
Overall survival:median and overall survival
Time frame: at one and two years
Response rates
Time frame: at end of treatment
Toxicity
Time frame: during treatment
Late toxicity
Time frame: 2 to 5 years after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
- Results publication: PubMed 17134114Omuro AM, Abrey LE. Chemotherapy for primary central nervous system lymphoma. Neurosurg Focus. 2006 Nov 15;21(5):E12. doi: 10.3171/foc.2006.21.5.13.
- Derived from this study: PubMed 26688235Omuro A, Chinot O, Taillandier L, Ghesquieres H, Soussain C, Delwail V, Lamy T, Gressin R, Choquet S, Soubeyran P, Huchet A, Benouaich-Amiel A, Lebouvier-Sadot S, Gyan E, Touitou V, Barrie M, del Rio MS, Gonzalez-Aguilar A, Houillier C, Delgadillo D, Lacomblez L, Tanguy ML, Hoang-Xuan K. Methotrexate and temozolomide versus methotrexate, procarbazine, vincristine, and cytarabine for primary CNS lymphoma in an elderly population: an intergroup ANOCEF-GOELAMS randomised phase 2 trial. Lancet Haematol. 2015 Jun;2(6):e251-9. doi: 10.1016/S2352-3026(15)00074-5. Epub 2015 Jun 3.
- A review on chemotherapy options for primary central nervous system lymphomaLink provided by the sponsor.
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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.
Antonio OMURO, MD, principal investigator
Assistance Publique - Hôpitaux de Paris
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 Methotrexate and temozolomide and Methotrexate , procarbazine ,vincristine ,cytarabine in people with Lymphoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 30 Jul 2012. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio OMURO, MD,PhD (+ 33(0) 1 42 16 41 60, antonio.omuro@psl.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: at one year). 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 NCT00503594, which also lists 2 linked publications.
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 30 Jul 2012.