NCT00001333

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P50-P75 for phase_1 leukemia

Timeline
Completed

Started Feb 1993

Longer than P75 for phase_1 leukemia

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1993

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2000

Completed
2 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

January 1, 2000

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

LeukemiaLymphomaMeningeal Neoplasms

Keywords

IntraventricularMeningeal MalignancyNSC 609699SKF 104864Topoisomerase 1

Interventions

topotecanDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

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

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Rowinsky EK, Grochow LB, Hendricks CB, Ettinger DS, Forastiere AA, Hurowitz LA, McGuire WP, Sartorius SE, Lubejko BG, Kaufmann SH, et al. Phase I and pharmacologic study of topotecan: a novel topoisomerase I inhibitor. J Clin Oncol. 1992 Apr;10(4):647-56. doi: 10.1200/JCO.1992.10.4.647.

    PMID: 1312588BACKGROUND

  • Adamson PC, Balis FM, Arndt CA, Holcenberg JS, Narang PK, Murphy RF, Gillespie AJ, Poplack DG. Intrathecal 6-mercaptopurine: preclinical pharmacology, phase I/II trial, and pharmacokinetic study. Cancer Res. 1991 Nov 15;51(22):6079-83.

    PMID: 1933871BACKGROUND

  • Blaney SM, Balis FM, Cole DE, Craig C, Reid JM, Ames MM, Krailo M, Reaman G, Hammond D, Poplack DG. Pediatric phase I trial and pharmacokinetic study of topotecan administered as a 24-hour continuous infusion. Cancer Res. 1993 Mar 1;53(5):1032-6.

    PMID: 8439950BACKGROUND

MeSH Terms

Conditions

LeukemiaLymphomaMeningeal Neoplasms

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNervous System Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

February 1, 1993

Study Completion

December 1, 2000

Last Updated

March 4, 2008

Record last verified: 2000-01

Locations

US(1)