Clinical trial · Interventional
DepoCyt Therapy in Patients With Neoplastic Meningitis From Lymphoma or a Solid Tumor
A Randomized Clinical Study to Determine the Patient Benefit and Safety of Depocyt (Cytarabine Liposome Injection) for the Treatment of Neoplastic Meningitis
NCT00029523CI-TRIAL-00000624completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to find out how well an experimental drug called DepoCyt works for neoplastic meningitis (cancer that has spread to the tissues around the brain and spinal cord). DepoCyt is a new slow-release form of the cancer drug called ara-C (cytarabine). Cytarabine has been used for many years to treat cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Meningeal Neoplasms | Meningeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intrathecal cytarabine (also known as ara-C) | Drug | — | UNRESOLVED |
| Intrathecal (injected into the spinal fluid) DepoCyt | Drug | — | UNRESOLVED |
| Intrathecal methotrexate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free survival, defined as the time to neurological progression or death
Secondary outcomes (7)
- measure
- Time to neurological progression;
- measure
- Survival (all-cause and meningeal disease-specific)
- measure
- Frequency of improvement in pre-existing meningeal-disease related neurological deficits
- measure
- Karnofsky Performance Scores (KPS)
- measure
- Quality of life
- measure
- Cytological response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* Diagnosed (or previously diagnosed) with lymphoma or a solid tumor (not leukemia) * Diagnosed with neoplastic meningitis * If female, not pregnant and will not become pregnant while on-study * No other experimental therapy within 21 days of participation
References
Publications (2)
- BACKGROUNDGlantz MJ, Jaeckle KA, Chamberlain MC, Phuphanich S, Recht L, Swinnen LJ, Maria B, LaFollette S, Schumann GB, Cole BF, Howell SB. A randomized controlled trial comparing intrathecal sustained-release cytarabine (DepoCyt) to intrathecal methotrexate in patients with neoplastic meningitis from solid tumors. Clin Cancer Res. 1999 Nov;5(11):3394-402. PMID 10589750
- BACKGROUNDGlantz MJ, LaFollette S, Jaeckle KA, Shapiro W, Swinnen L, Rozental JR, Phuphanich S, Rogers LR, Gutheil JC, Batchelor T, Lyter D, Chamberlain M, Maria BL, Schiffer C, Bashir R, Thomas D, Cowens W, Howell SB. Randomized trial of a slow-release versus a standard formulation of cytarabine for the intrathecal treatment of lymphomatous meningitis. J Clin Oncol. 1999 Oct;17(10):3110-6. doi: 10.1200/JCO.1999.17.10.3110. PMID 10506606