NCT00005811

Brief Summary

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well topotecan hydrochloride works in treating children with meningeal cancer that has not responded to previous treatment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2000

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 21, 2013

Status Verified

February 1, 2013

Enrollment Period

6 years

First QC Date

June 2, 2000

Last Update Submit

February 20, 2013

Conditions

AIDS-related Diffuse Large Cell LymphomaAIDS-related Diffuse Mixed Cell LymphomaAIDS-related Diffuse Small Cleaved Cell LymphomaAIDS-related Immunoblastic Large Cell LymphomaAIDS-related Lymphoblastic LymphomaAIDS-related Peripheral/Systemic LymphomaAIDS-related Primary CNS LymphomaAIDS-related Small Noncleaved Cell LymphomaChildhood Diffuse Large Cell LymphomaChildhood Immunoblastic Large Cell LymphomaHIV-associated Hodgkin LymphomaLeptomeningeal MetastasesRecurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Acute Myeloid LeukemiaRecurrent Childhood Large Cell LymphomaRecurrent Childhood Lymphoblastic LymphomaRecurrent Childhood MedulloblastomaRecurrent Childhood Small Noncleaved Cell LymphomaRecurrent/Refractory Childhood Hodgkin LymphomaUnspecified Childhood Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (4)

  • For the leukemia and lymphoma patients, an objective response rate, defined to be the proportion of Complete Responses of less than 0.10

    Up to 54 months

  • For the patients with solid tumors, a proportion of patients who do not experience an event, defined to be death, progressive disease, relapse, or second malignancy of less than 0.3

    Up to 54 months

  • Safety and toxicity

    Up to 54 months

  • Concentration of matrix metalloproteinases in the CSF

    Up to 54 months

Study Arms (1)

Treatment (topotecan hydrochloride)

EXPERIMENTAL

INDUCTION: Patients receive topotecan hydrochloride IT over 5 minutes twice weekly for 6 weeks. CONSOLIDATION: Beginning 1 week after completion of induction, patients receive topotecan hydrochloride IT over 5 minutes weekly for 4 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Beginning 2 weeks after completion of consolidation, patients receive topotecan hydrochloride IT over 5 minutes twice monthly for 4 months and then monthly through year 1.

Drug: topotecan hydrochlorideOther: laboratory biomarker analysis

Interventions

topotecan hydrochlorideDRUG

Given IT

Also known as: hycamptamine, Hycamtin, SKF S-104864-A, TOPO
Treatment (topotecan hydrochloride)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (topotecan hydrochloride)

Eligibility Criteria

Age1 Year - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Histologically proven refractory leukemia, lymphoma, or other solid tumor thathas overt meningeal involvement (Recurrent CNS acute lymphoblastic leukemia stratum only open to accrual as of 11/30/04)
  • Definition of meningeal disease:
  • Leukemia/lymphoma (including acute lymphoblastic leukemia)
  • CSF cell count greater than 5/mm\^3 AND evidence of blast cells oncytospin preparation or by cytology
  • Refractory to conventional therapy, including radiotherapy (i.e., in second or greater relapse)
  • No concurrent bone marrow relapse
  • Solid tumors (including medulloblastoma)
  • Presence of tumor cells on cytospin preparation or cytology OR presence ofmeningeal disease on MRI scans
  • No clinical evidence of obstructive hydrocephalus or compartmentalization ofCSF flow as documented by radioisotope indium In 111 or technetium Tc 99 DTPAflow study
  • If CSF flow block is demonstrated, focal radiotherapy must be administered tosite of block to restore flow and a repeat CSF flow study must show clearing of blockage
  • No ventriculoperitoneal or ventriculoatrial shunt unless:
  • Patient is shunt independent and there is evidence that the shunt is nonfunctional
  • CSF flow study demonstrates normal flow
  • No impending cord compression, CNS involvement requiring local radiotherapy(e.g., optic nerve), or isolated bulky ventricular or leptomeningeal basedlesions
  • Performance status - Lansky 50-100% (age 10 and under)
  • +25 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseMeningeal CarcinomatosisPrecursor Cell Lymphoblastic Leukemia-LymphomaDendritic Cell Sarcoma, InterdigitatingMedulloblastomaBurkitt LymphomaRecurrence

Interventions

Topotecantrioctyl phosphine oxide

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesMeningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNervous System DiseasesLeukemia, LymphoidLeukemiaHematologic DiseasesHistiocytic Disorders, MalignantHistiocytosisGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeuroectodermal Tumors, PrimitiveNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Susan Blaney

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2000

First Posted

January 27, 2003

Study Start

April 1, 2000

Primary Completion

April 1, 2006

Study Completion

February 1, 2009

Last Updated

February 21, 2013

Record last verified: 2013-02

Locations

US(1)