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Phase I Study of Intrathecal Topotecan

Phase 1
Not Enrolling
Leukemia, Lymphoma, Meningeal Neoplasms

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Trial Information

Phase I Study of Intrathecal Topotecan

The purpose of this study is to determine the qualitative and quantitative toxicity of
intrathecal topotecan, a topoisomerase I inhibitor, in patients with meningeal malignancies
refractory to conventional therapy (radiation therapy and chemotherapy). A safe dose of
topotecan that can be recommended for intrathecal administration in subsequent phase II
studies will be established in a limited dosage escalation schedule. The CSF
pharmacokinetics of intrathecal topotecan will also be studied. Topotecan will be
administered intrathecally on a bi-weekly basis for four to six weeks, followed by weekly
administration for 1 month, twice monthly administration for four months and then monthly IT

Inclusion Criteria


Leukemia, lymphoma, or solid tumor with overt meningeal involvement considered refractory
to conventional therapy.

CSF leukemic cell count at least 5 per cubic millimeter with evidence of blast cells on
cytospin or cytology required for leukemia and lymphoma patients.

Tumor cells on cytospin or cytology or measurable meningeal disease on CT or MRI required
for patients with solid tumors.

No clinical evidence of obstructive hydrocephalus or compartmentalization of the CSF flow
as documented by indium-111- or technetium-99-DPTA flow study.


At least 1 week since CNS therapy.

Biologic Therapy: Recovery from toxic effects of prior immunotherapy required.


Recovery from toxic effects of prior chemotherapy required.

No concomitant therapy to treat meningeal malignancy (intrathecal or systemic).

Concomitant chemotherapy to control systemic disease or bulk CNS disease allowed except:
Investigational agents. Agents that penetrate the CNS (e.g., high-dose methotrexate,
thiotepa, high-dose cytarabine, fluorouracil, intravenous mercaptopurine).

Agents known to have serious unpredictable CNS side effects.

Endocrine Therapy: Not specified.

Radiotherapy: Recovery from toxic effects of prior radiotherapy required. Patient
eligible if flow restored following focal radiotherapy to the blockage site.

Surgery: Not specified.


Age: 3 and over (older patients giving consent will be enrolled before the very young, if

Performance status: ECOG 0-2.

Life expectancy: At least 8 weeks.

Hematopoietic: See Disease Characteristics.

Hepatic: Bilirubin less than 2.0 mg/dL, SGPT less than 3 times normal.

Renal: Creatinine less than 1.5 mg/dL.

Metabolic: Serum electrolytes (including calcium and phosphate) normal.

Other: No significant systemic illness (e.g., infection). Not pregnant or lactating.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment


United States: Federal Government

Study ID:




Start Date:

February 1993

Completion Date:

December 2000

Related Keywords:

  • Leukemia
  • Lymphoma
  • Meningeal Neoplasms
  • Intraventricular
  • Meningeal Malignancy
  • NSC 609699
  • SKF 104864
  • Topoisomerase 1
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Meningeal Neoplasms



National Cancer Institute (NCI) Bethesda, Maryland  20892