Who is sponsoring NCT00112619?

NCT00112619 is sponsored by Pediatric Brain Tumor Consortium.

What drugs are being tested in NCT00112619?

Interventions in NCT00112619: topotecan hydrochloride.

What condition does NCT00112619 study?

NCT00112619 studies Brain and Central Nervous System Tumors, Carcinoma of Unknown Primary, Leukemia, Lymphoma, Unspecified Childhood Solid Tumor, Protocol Specific.

Is NCT00112619 still recruiting?

NCT00112619 is currently terminated. Last updated 29 June 2011.

Last reviewed 2011-06-29 · How we verify

NCT00112619

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase I Pharmacokinetic Optimal Dosing Study of Intraventricular Topotecan for Children With Neoplastic Meningitis

Terminated Phase 1 Last updated 29 June 2011

What this trial tests

Phase 1 trial testing topotecan hydrochloride in Brain and Central Nervous System Tumors in 19 participants. Terminated before completion.

Timeline

1 August 2005

Primary endpoint
1 August 2010

Quick facts

Lead sponsor	Pediatric Brain Tumor Consortium
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	1 August 2005
Primary completion	1 August 2010
Sites	11 locations across United States

Drugs / interventions tested

topotecan hydrochloride — full drug profile →

Conditions studied

Brain and Central Nervous System Tumors — all drugs for Brain and Central Nervous System Tumors →
Carcinoma of Unknown Primary — all drugs for Carcinoma of Unknown Primary →
Leukemia — all drugs for Leukemia →
Lymphoma — all drugs for Lymphoma →

Sponsor

Pediatric Brain Tumor Consortium

Who can join

Adults 3 to 21, any sex, with Brain and Central Nervous System Tumors or Carcinoma of Unknown Primary. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Estimate the maximum tolerated dose of intraventricular topotecan on this schedule
Time frame: First 14 days of therapy
Number of patients with dose-limiting toxicity
Time frame: First 14 days of therapy
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
Time frame: Day 1 of Week 1

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Case-based review: atypical teratoid/rhabdoid tumor.
Nesvick CL, Nageswara Rao AA, Raghunathan A, Biegel JA, et al · · 2019 · cited 23× · PMID 31386032 · DOI 10.1093/nop/npy037
Targeting the medulloblastoma: a molecular-based approach.
Luzzi S, Giotta Lucifero A, Brambilla I, Semeria Mantelli S, et al · · 2020 · cited 19× · PMID 32608377 · DOI 10.23750/abm.v91i7-s.9958

Verify or expand the search:

Other trials of topotecan hydrochloride

Trials testing the same drug.

NCT00499616 — Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma · Phase 3 · completed
NCT00638898 — Busulfan, Melphalan, Topotecan Hydrochloride, and a Stem Cell Transplant in Treating Patients With Newly Diagnosed or Re · Phase 1 · completed
NCT00025272 — Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer · Phase 2 · completed
NCT00028743 — Combination Chemotherapy Regimens in Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer · Phase 3 · completed
NCT00003372 — Topotecan in Treating Patients With Recurrent Brain Tumors · Phase 2 · completed

Other recruiting trials for Brain and Central Nervous System Tumors

Currently open trials in the same condition.

NCT00978458 — Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma · Phase 3 · active not recruiting

Other Pediatric Brain Tumor Consortium trials

Trials by the same sponsor.

NCT04482933 — HSV G207 With a Single Radiation Dose in Children With Recurrent High-Grade Glioma · Phase 2 · withdrawn
NCT05934630 — Testing Cerebrospinal Fluid for Cell-free Tumor DNA in Children, Adolescents, and Young Adults With Brain Tumors · suspended
NCT04743661 — 131I-Omburtamab, in Recurrent Medulloblastoma and Ependymoma · Phase 2 · active not recruiting
NCT04295759 — INCB7839 in Treating Children With Recurrent/Progressive High-Grade Gliomas · Phase 1 · completed
NCT04201457 — A Trial of Dabrafenib, Trametinib and Hydroxychloroquine for Patients With Recurrent LGG or HGG With a BRAF Aberration · Phase 1, PHASE2 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00112619 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pediatric Brain Tumor Consortium
Last refreshed: 29 June 2011

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00112619.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing