Clinical trial · Interventional
Intrathecal Busulfan in Treating Patients With Recurrent, Refractory, or Metastatic Leptomeningeal Tumors
Phase I Study of Intrathecal Spartaject-Busulfan in Patients With Neoplastic Meningitis
NCT00003462CI-TRIAL-00009521completedPhase 1ClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs into the thin space between the lining of the spinal cord and brain may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of intrathecal busulfan in treating patients with recurrent, refractory, or metastatic leptomeningeal tumors.
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 |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| busulfan | Drug | Busulfan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed neoplasm that is metastatic in the cerebrospinal fluid or leptomeningeal/subarachnoid space * Cytologic diagnosis of malignancy in the cerebrospinal fluid or neuroimaging evidence of leptomeningeal tumor by MRI * Must have a recurrent or refractory leptomeningeal tumor * Leptomeningeal tumors of leukemia, lymphoma, and all germ cell tumors must have also failed initial treatment or be recurrent * No evidence of obstructive hydrocephalus or complete block of the spinal cerebrospinal fluid pathways on prestudy technetium Tc 99m albumin or indium In 111 DTPA flow study PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * At least 8 weeks Hematopoietic: * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin less than 2.5 mg/dL * SGOT or SGPT less than 1.5 times normal Renal: * BUN less than 30 mg/dL * Creatinine less than 1.5 mg/dL * Calcium within normal limits Neurological: * Neurological examination stable * No rapidly progressing or deteriorating neurological deficits Other: * No active infectious process * Magnesium, phosphorus, potassium, chloride, and bicarbonate normal * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy Chemotherapy: * At least 6 weeks since prior nitrosoureas or mitomycin * At least 4 weeks since any other prior chemotherapy * At least 3 weeks since prior intrathecal chemotherapy * No other concurrent intrathecal chemotherapy Endocrine therapy: * For patients on corticosteroids: * Must be on a stable dose of corticosteroids for at least 1 week Radiotherapy: * At least 3 weeks since prior radiotherapy to the CNS * At least 4 weeks since any other prior radiotherapy * No concurrent radiotherapy to the CNS Surgery: * At least 3 weeks since prior surgery Other: * No concurrent medication that may interfere with study results (e.g., immunosuppressive agents other than corticosteroids)
References
Publications (0)
Data not yet available
No reference posted for this study.