RADIOCHEMIOTERAPIA CON TEMOZOLOMIDE CONCOMITANTE E ADIUVANTE NEL TRATTAMENTO DEI LINFOMI CEREBRALI PRIMITIVI DOPO METOTREXATE AD ALTE DOSI: STUDIO DI DOSE ESCALATION - ND
Active, not recruiting
- Conditions
- primary central nervous lymphomaMedDRA version: 9.1Level: HLGTClassification code 10025323Term: Lymphomas NEC
- Registration Number
- EUCTR2007-003254-28-IT
- Lead Sponsor
- POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
histologic diagnosis of PCNSL
ND-MTX
Exclusive localization of intracranial disease
written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
hiv
pregnancy
organ failure
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: evaluation of maximum tolerated dose of temozolomide concomitant to radiation therapy in patients treated with HD-MTX;Secondary Objective: evaluation of response rate and survival;Primary end point(s): concomitant temozolamide mtd
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie temozolomide's efficacy in primary central nervous system lymphoma after high-dose methotrexate?
How does temozolomide-based chemoradiotherapy compare to standard regimens for PCNSL in terms of progression-free survival and toxicity profiles?
Which biomarkers correlate with response to temozolomide in high-dose methotrexate-treated PCNSL patients?
What are the most common adverse events associated with concurrent temozolomide and radiation therapy for primary brain lymphomas?
Are there synergistic combination strategies involving temozolomide and novel immunotherapies for central nervous system lymphomas?