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Phase I Study of Intrathecal Spartaject-Busulfan in Patients With Neoplastic Meningitis


Phase 1
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

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Trial Information

Phase I Study of Intrathecal Spartaject-Busulfan in Patients With Neoplastic Meningitis


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Henry S. Friedman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Federal Government

Study ID:

0672

NCT ID:

NCT00003462

Start Date:

April 1998

Completion Date:

February 2001

Related Keywords:

  • Brain and Central Nervous System Tumors
  • leptomeningeal metastases
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710