Intrathecal Busulfan in Treating Patients With Recurrent, Refractory, or Metastatic Leptomeningeal Tumors - Full Text View

Sponsor:	Duke University
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003462

Purpose

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	Intervention	Phase
Metastatic Cancer	Drug: busulfan	Phase I

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase I Study of Intrathecal Spartaject-Busulfan in Patients With Neoplastic Meningitis

Resource links provided by NLM:

MedlinePlus related topics: Cancer Meningitis

Drug Information available for: Busulfan

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	20
Study Start Date:	April 1998

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003462

Locations

United States, North Carolina
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 University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000066494, 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
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00003462 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

leptomeningeal metastases

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplastic Processes
Neoplasms

Pathologic Processes
Therapeutic Uses
Busulfan
Myeloablative Agonists
Neoplasm Metastasis
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on November 09, 2009