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CompletedNCT00003462Updated Feb 20, 2013

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

A Phase 1 interventional study of busulfan in Brain and Central Nervous System Tumors, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-20.

Sponsored by Duke University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs into the thin space between the lining of the spinal cord and brain may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of intrathecal busulfan in treating patients with recurrent, refractory, or metastatic leptomeningeal tumors.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose of intrathecal busulfan by a limited escalation dosage schedule in patients with recurrent or refractory leptomeningeal tumors.
  • Determine the cerebrospinal fluid and serum pharmacokinetics of busulfan administered via intralumbar or intraventricular routes in these patients.

OUTLINE: This is dose-escalation study.

Patients receive intrathecal busulfan via intralumbar or intraventricular routes twice a week for 2 weeks (4 treatments). Any patient with objective or significant clinical response may continue treatment by receiving the same dose once a week for 2 consecutive weeks, once a week every other week for 3 weeks (2 treatments), and then once a month thereafter until disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of intrathecal busulfan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 12 weeks for 1 year or until disease progression.

PROJECTED ACCRUAL: A total of 5-20 patients will be accrued for this study within 1-2 years.

02

Conditions studied

  • Brain and Central Nervous System Tumors

Keywords

  • leptomeningeal metastases
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In context

Nervous System Neoplasms

538 studies on the registry are indexed under Nervous System Neoplasms; 14 are open to participants now.

This study's planned enrollment of 20 is below the median of 35 across 379 interventional studies indexed under Nervous System Neoplasms.

Browse Nervous System Neoplasms studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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)
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Study design

Phase
Phase 1
Primary purpose
Treatment
Enrollment
20 participants (estimated)

Interventions

  • Drugbusulfan
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Study locations

1 site
  • Duke Comprehensive Cancer Center
    Durham, North Carolina 27710, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00003462
Lead sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Apr 1998
Primary completion
Feb 2001
Completion
Feb 2001
Last update
Feb 20, 2013

Study contacts

Henry S. Friedman, MD
study chair · Duke Cancer Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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