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

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT00003462
Collaborator
National Cancer Institute (NCI) (NIH)
20
Enrollment
1
Location
34.1
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Primary Purpose:
Treatment
Official Title:
Phase I Study of Intrathecal Spartaject-Busulfan in Patients With Neoplastic Meningitis
Study Start Date :
Apr 1, 1998
Actual Primary Completion Date :
Feb 1, 2001
Actual Study Completion Date :
Feb 1, 2001

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Duke Comprehensive Cancer Center Durham North Carolina United States 27710

    Sponsors and Collaborators

    • Duke University
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Henry S. Friedman, MD, Duke Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT00003462
    Other Study ID Numbers:
    • 0672
    • DUMC-0672-03-3R5
    • DUMC-000672-02-3R4
    • DUMC-000672-00-3R2
    • DUMC-000672-01-3R3
    • DUMC-0631-99-4RI
    • DUMC-625-98-4
    • DUMC-98045
    • DUMC-FDR001519
    • NCI-G98-1463
    • CDR0000066494
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Feb 20, 2013
    Last Verified:
    Feb 1, 2013
    Keywords provided by Duke University
    leptomeningeal metastases
    Additional relevant MeSH terms:
    Nervous System Neoplasms
    Central Nervous System Neoplasms
    Busulfan

    Study Results

    No Results Posted as of Feb 20, 2013