Intrathecal Busulfan in Treating Patients With Recurrent, Refractory, or Metastatic Leptomeningeal Tumors
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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 |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: busulfan |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I Study of Intrathecal Spartaject-Busulfan in Patients With Neoplastic Meningitis |
| Estimated Enrollment: | 20 |
| Study Start Date: | April 1998 |
| Study Completion Date: | February 2001 |
| Primary Completion Date: | February 2001 (Final data collection date for primary outcome measure) |
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 |
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| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Study Chair: | Henry S. Friedman, MD | Duke Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00003462 History of Changes |
| 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 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 15, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Duke University:
|
leptomeningeal metastases |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms by Site Neoplasms Nervous System Diseases Busulfan Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Myeloablative Agonists |
ClinicalTrials.gov processed this record on May 16, 2013