Trials Sponsors Conditions Drugs Pricing

Conditions

Brain and Central Nervous System Tumors

Keywords

leptomeningeal metastases

Interventions

busulfanDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed neoplasm that is metastatic in the cerebrospinal fluid or leptomeningeal/subarachnoid space * Cytologic diagnosis of malignancy in the cerebrospinal fluid or neuroimaging evidence of leptomeningeal tumor by MRI * Must have a recurrent or refractory leptomeningeal tumor * Leptomeningeal tumors of leukemia, lymphoma, and all germ cell tumors must have also failed initial treatment or be recurrent * No evidence of obstructive hydrocephalus or complete block of the spinal cerebrospinal fluid pathways on prestudy technetium Tc 99m albumin or indium In 111 DTPA flow study PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * At least 8 weeks Hematopoietic: * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin less than 2.5 mg/dL * SGOT or SGPT less than 1.5 times normal Renal: * BUN less than 30 mg/dL * Creatinine less than 1.5 mg/dL * Calcium within normal limits Neurological: * Neurological examination stable * No rapidly progressing or deteriorating neurological deficits Other: * No active infectious process * Magnesium, phosphorus, potassium, chloride, and bicarbonate normal * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy Chemotherapy: * At least 6 weeks since prior nitrosoureas or mitomycin * At least 4 weeks since any other prior chemotherapy * At least 3 weeks since prior intrathecal chemotherapy * No other concurrent intrathecal chemotherapy Endocrine therapy: * For patients on corticosteroids: * Must be on a stable dose of corticosteroids for at least 1 week Radiotherapy: * At least 3 weeks since prior radiotherapy to the CNS * At least 4 weeks since any other prior radiotherapy * No concurrent radiotherapy to the CNS Surgery: * At least 3 weeks since prior surgery Other: * No concurrent medication that may interfere with study results (e.g., immunosuppressive agents other than corticosteroids)

Sponsors & Collaborators

National Cancer Institute (NCI)
NIHcollaborator
Duke University
Otherlead

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

MeSH Terms

Conditions

Central Nervous System NeoplasmsMeningeal Carcinomatosis

Interventions

Busulfan

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesMeningeal Neoplasms

Intervention Hierarchy (Ancestors)

Butylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylates

Study Officials

Henry S. Friedman, MD
Duke Cancer Institute
STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

April 1998

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2001

Actual (reported)

Intrathecal Busulfan in Treating Patients With Recurrent, Refractory, or Metastatic Leptomeningeal Tumors

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

Primary Completion

Study Completion

First Posted

Conditions

Keywords

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

Primary Completion

Study Completion

First Posted

Conditions

Keywords

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations