Clinical trial · Interventional
Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma
A Pilot Phase II Trial of Temozolomide in Leptomeningeal Metastases
NCT00005812CI-TRIAL-00010286terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No objective response documented, protocol terminated after 12 patients.
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have leptomeningeal metastases from a solid tumor or lymphoma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumors | Brain Neoplasm | ALIAS | 0.90 |
| Central Nervous System Tumors | Central Nervous System Neoplasm | ALIAS | 0.90 |
| Leptomeningeal Metastases | Meningeal Carcinomatosis | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Temozolomide
- description
- Oral temozolomide 75 mg/m2/day for 6 weeks, followed by 4 week break. Cycles will continue until: * disease progression * intolerable toxicity * complete response - 2 full additional cycles * if response is complete except for residual radiographic abnormalities that persist unchanged for 2 full cycles: continue for 4 cycles past best response.
- interventionNames
- Drug: temozolomide
Primary outcomes (1)
- measure
- Objective Response
- timeFrame
- Every 6 weeks
- description
- Response will be assessed clinically, cytologically, and radiographically.
Secondary outcomes (3)
- measure
- Pharmacokinetics
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* Documented leptomeningeal metastases * Carcinomatous meningitis that is previously untreated or failed prior therapy OR * Lymphomatous meningitis * Systemic disease that is responding or stable on current therapy not eligible if discontinuing therapy would be deleterious * Age 18 and over * Karnofsky Performance Status 60-100% * Life expectancy of at least 6 weeks * Absolute neutrophil count greater than 1,500/μL * Platelet count greater than 100,000/μL * Creatinine no greater than 2.0 mg/dL * No congestive heart failure * No unstable angina * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No contraindication to diagnostic sampling of CSF via lumbar puncture or reservoir * No medical conditions that would interfere with absorption of oral medication (e.g., malabsorption, obstruction, or frequent vomiting) * No uncontrolled infection * Prior neuroaxis chemotherapy (lumbar puncture, reservoir, or systemic) allowed * No other concurrent chemotherapy for other sites of disease * No prior radiotherapy to areas of measurable meningeal disease unless there is clear radiographic progression in these areas * No prior radiotherapy to greater than 30% of bone marrow * Prior radiotherapy to the neuroaxis allowed * No concurrent radiotherapy for other sites of disease or for progressive disease * Recovered from any prior recent therapy
References
Publications (1)
- RESULTDavis TH, Fadul CE, Glantz MJ, et al.: Pilot phase II trial of temozolomide for leptomeningeal metastases: preliminary report. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-460, 2003. ISBN 1932312021