Search / Trial NCT00001333

Phase I Study of Intrathecal Topotecan

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Intraventricular Meningeal Malignancy Nsc 609699 Skf 104864 Topoisomerase 1

Description

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 ...

Gender

All

Eligibility criteria

  • DISEASE CHARACTERISTICS:
  • 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.
  • PRIOR/CONCURRENT THERAPY:
  • At least 1 week since CNS therapy.
  • Biologic Therapy: Recovery from toxic effects of prior immunotherapy required.
  • Chemotherapy:
  • 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.
  • PATIENT CHARACTERISTICS:
  • Age: 3 and over (older patients giving consent will be enrolled before the very young, if possible).
  • 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.

Attachments

readout_NCT00001333_2023-12-10.pdf

4.5 MB

NCT00001333_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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