Topotecan in Treating Young Patients With Neoplastic Meningitis Due to Leukemia, Lymphoma, or Sol… (NCT00112619) | Clinical Trial Compass
TerminatedPhase 1
Topotecan in Treating Young Patients With Neoplastic Meningitis Due to Leukemia, Lymphoma, or Solid Tumors
Stopped: Slow accrual and company withdrawing support to supply the drug
United States19 participantsStarted 2005-08
Plain-language summary
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.
Who can participate
Age range3 Years – 21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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/ÎĽL 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
* No…
What they're measuring
1
Estimate the maximum tolerated dose of intraventricular topotecan on this schedule
Timeframe: First 14 days of therapy
2
Number of patients with dose-limiting toxicity
Timeframe: First 14 days of therapy
3
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