Clinical trial · Interventional
Topotecan in Treating Young Patients With Neoplastic Meningitis Due to Leukemia, Lymphoma, or Solid Tumors
A Phase I Pharmacokinetic Optimal Dosing Study of Intraventricular Topotecan for Children With Neoplastic Meningitis
NCT00112619CI-TRIAL-00005134terminatedPhase 1ClinicalTrials.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): Slow accrual and company withdrawing support to supply the drug
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of topotecan when given by intraventricular infusion in treating young patients with neoplastic meningitis due to leukemia, lymphoma, or solid tumors.
Conditions
Conditions (5)
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 | — |
| Carcinoma of Unknown Primary | Carcinoma of Unknown Primary | ONTOLOGY_EXACT | 0.98 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Estimate the maximum tolerated dose of intraventricular topotecan on this schedule
- timeFrame
- First 14 days of therapy
- measure
- Number of patients with dose-limiting toxicity
- timeFrame
- First 14 days of therapy
- measure
- Estimate the dose of intraventricular topotecan that will result in cerebrospinal fluid lactone concentrations exceeding 1 ng/mL for at least 8 hours after an intrathecal injection
- timeFrame
- Day 1 of Week 1
Secondary outcomes (3)
- measure
- Number of patients with objective documentation of tumor response to intraventricular topotecan
- timeFrame
- Weeks 5, 11 and then every 12 weeks until off study
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of neoplastic meningitis secondary to leukemia, lymphoma (including AIDS-related lymphoma), or solid tumor (including primary CNS tumors or carcinomas of unknown primary site), defined by 1 of the following criteria: * Cerebral spinal fluid (CSF) cell count \> 5/μL AND evidence of blast cells on cytospin or by cytology (for patients with leukemia or lymphoma) * Presence of tumor cells on cytospin or cytology OR unequivocal presence of meningeal disease by MRI (for patients with solid tumor) * No conventional therapy for neoplastic meningitis exists * Patients with CNS leukemia or lymphoma must be refractory to conventional therapy, including radiotherapy (i.e., second or greater relapse) * Patients with CNS leukemia or lymphoma must have had a negative bone marrow aspiration within the past 2 weeks * No clinical evidence of obstructive hydrocephalus * No compartmentalization of CSF flow by radioisotope indium In 111 or technetium Tc 99 DTPA flow study * No ventriculoperitoneal or ventriculoatrial shunt unless patient is completely shunt-independent * No impending spinal cord compression or other CNS involvement (e.g., acute visual loss secondary to optic nerve involvement) requiring emergent local radiotherapy PATIENT CHARACTERISTICS: Age * 3 to 21 Performance status * Lansky 60-100% (≤ 16 years of age) OR * Karnofsky 60-100% (\> 16 years of age) Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Calcium ≥ 7 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Sodium 125-150 mmol/L * Magnesium ≥ 0.7 mmol/L * Must have or be willing to have an intraventricular access device (i.e., Ommaya reservoir) * No uncontrolled infection * HIV-positive patients with AIDS-related lymphomatous meningitis are eligible * No other significant uncontrolled systemic medical illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Recovered from prior biologic therapy or immunotherapy Chemotherapy * Recovered from prior chemotherapy * At least 1 week since prior intra-colony stimulating factory (CSF) chemotherapy (2 weeks for liposomal cytarabine) * At least 3 weeks since prior systemic chemotherapy for leptomeningeal disease * Concurrent systemic chemotherapy to control systemic disease or bulk CNS disease allowed provided the systemic chemotherapy is not an investigational agent OR any of the following: * High-dose (\> 1 g/m\^2) methotrexate * High-dose (\> 1 g/m\^2) cytarabine * Fluorouracil * Capecitabine * Thiotepa * Nitrosoureas * Topotecan Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 8 weeks since prior craniospinal radiotherapy and recovered * No concurrent CNS radiotherapy * Concurrent radiotherapy to extra-CNS sites (e.g., painful bone metastases not in the craniospinal axis) allowed Surgery * Not specified Other * More than 2 weeks since prior and no other concurrent investigational agents * No other concurrent intra-CSF or systemic therapy for leptomeningeal disease
References
Publications (0)
Data not yet available
No reference posted for this study.