Completed

Phase I Study of Intrathecal Topotecan

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What is being tested

topotecan

Drug
Who is being recruted

Leukemia

+ Lymphoma
+ Meningeal Neoplasms
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: February 1993

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 1993Actual date on which the first participant was enrolled.

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). 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 administration.

Official TitlePhase I Study of Intrathecal Topotecan 
Principal SponsorNational Cancer Institute (NCI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
30 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Leukemia
Lymphoma
Meningeal Neoplasms
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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
National Cancer Institute (NCI)Bethesda, United StatesSee the location

CompletedOne Study Center