NCT00025311

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of intrathecal or intraventricular topotecan in treating recurrent, progressive, or refractory cancer that is metastatic to the lining around the brain.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2001

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
Last Updated

November 9, 2012

Status Verified

March 1, 2003

Enrollment Period

2.4 years

First QC Date

October 11, 2001

Last Update Submit

November 8, 2012

Conditions

Brain and Central Nervous System Tumors

Keywords

leptomeningeal metastases

Interventions

topotecan hydrochlorideDRUG

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologic or tumor marker confirmation of malignancy at original diagnosis * Neoplastic meningitis/leptomeningeal metastasis refractory to conventional therapy and other therapies of higher priority, defined as: * Stratum A: * Small non-cleaved lymphoma (Burkitt's) with any L-3 blast in cerebrospinal fluid (CSF) * Any other lymphoma or leukemia with CSF cell count greater than 5/mm3 AND evidence of blast cells by cytology or cytospin preparation OR * Stratum B: * Solid tumor or other malignancy with presence of tumor cells on cytospin OR positive cytology OR neuroimaging evidence of leptomeningeal tumor by MRI or CT myelogram * No leptomeningeal leukemia or lymphoma with concurrent bone marrow relapse * No clinical evidence of untreated obstructive hydrocephalus or compartmentalization of the CSF PATIENT CHARACTERISTICS: Age: * 65 and under Performance status: * Lansky 50-100% (age 16 and under) * Karnofsky 50-100% OR ECOG 0-3 (over age 16) Life expectancy: * At least 2 months Hematopoietic: * Stratum B: * Absolute neutrophil count at least 750/mm\^3 * Platelet count at least 75,000/mm\^3 (transfusion independent) * Hemoglobin at least 10.0 g/dL (red blood cell transfusions allowed) Hepatic: * Bilirubin no greater than 1.5 times normal * SGOT or SGPT less than 2.5 times upper limit of normal Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min Neurologic: * Seizures allowed if well controlled and on anticonvulsants * CNS toxicity no greater than grade 2 Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled infections * HIV allowed PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunomodulating agents (stratum B) * No stem cell transplantation (stratum A) Chemotherapy: * At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) * No other concurrent cancer chemotherapy (stratum B) * Other concurrent systemic cancer chemotherapy for leukemia or lymphoma allowed with the following restrictions: * No oral or IV topotecan * No moderate or high-dose IV or subcutaneous cytarabine (greater than 1.0 g/m2 per day) * No moderate or high-dose IV methotrexate (greater than 1 g/m2 per day) * No IV thiotepa * No myeloablative chemotherapy * No intrathecal or intraventricular chemotherapy Endocrine therapy: * Concurrent corticosteroids allowed only for treatment of increased intracranial pressure in patients with CNS tumors * No concurrent intrathecal or intraventricular hydrocortisone Radiotherapy: * At least 4 weeks since completion of radiotherapy to the brain or spine and recovered * Concurrent radiotherapy to localized painful lesions producing acute neurologic dysfunction allowed provided at least 1 measurable lesion is not irradiated * No concurrent craniospinal or whole-brain radiotherapy Surgery: * Not specified Other: * Recovered from prior therapy * At least 7 days since prior investigational drug * No other concurrent intrathecal or intraventricular therapy for leptomeningeal disease

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

CHU Pitie-Salpetriere

Paris, 75651, France

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsMeningeal Carcinomatosis

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesMeningeal Neoplasms

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Jonathan L. Finlay, MB, ChB

    NYU Langone Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2001

First Posted

January 27, 2003

Study Start

May 1, 2001

Primary Completion

October 1, 2003

Last Updated

November 9, 2012

Record last verified: 2003-03

Locations

FR(1)US(2)