Melphalan in Patients With Neoplastic Meningitis - Article Alkeran; L-PAM
Clinical Trial: Melphalan in Patients With Neoplastic Meningitis
This study is no longer recruiting patients.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of melphalan in patients with persistent or recurrent neoplastic meningitis.
|Condition||Treatment or Intervention||Phase|
| Drug: melphalan ||Phase I |
MedlinePlus related topics: Brain Cancer; Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphoma
Study Type: Interventional
Study Design: Treatment
Study start: December 1992
OBJECTIVES: I. Estimate the maximum tolerated dose of intrathecal melphalan (L-PAM) that can be given in patients with neoplastic meningitis. II. Determine the cerebrospinal fluid and serum pharmacokinetics of L-PAM administered via an Ommaya reservoir.
PROTOCOL OUTLINE: Single-Agent Intrathecal Chemotherapy. Melphalan, L-PAM, NSC-8806.
PROJECTED ACCRUAL: At least 3 children and 3 adults will be treated at each dose studied in Escalation 2.
Ages Eligible for Study: 3 Years and above
PROTOCOL ENTRY CRITERIA:
- Histologically confirmed malignancy that is metastatic to the cerebrospinal fluid (CSF) or leptomeningeal/subarachnoid space, including the following: Leukemia; Lymphoma; Germ cell tumors
- Persistent or recurrent disease required
- Cytologic evidence of malignancy in CSF or evidence of leptomeningeal tumor by CT or MRI
- No obstructive hydrocephalus or complete block of spinal CSF pathways on pre- study MRI or CT
- No rapidly progressing or deteriorating neurological deficit
- At least 3 weeks since intrathecal chemotherapy or radiotherapy to the CNS Systemic chemotherapy within 3 weeks of entry allowed at investigator's discretion; No concurrent intrathecal chemotherapy or radiotherapy to the CNS
- Age: 3 and over
- Performance status: Karnofsky 60%-100% (Lansky 60%-100% in children under 10 years)
- Life expectancy: At least 8 weeks
- Hematopoietic: (lower values allowed with approval of the investigator) ANC greater than 1,000; Platelets greater than 100,000
- Hepatic: Bilirubin less than 3.0 mg/dL
- Renal: Creatinine less than 2 mg/dL; BUN less than 30 mg/dL; Electrolytes (including calcium, magnesium, phosphate) normal
- Other: No active infection; Negative pregnancy test required of fertile women; Effective contraception required of fertile women
Duke Comprehensive Cancer Center, Durham, North Carolina, 27710, United States
Henry S. Friedman, Study Chair, Duke Comprehensive Cancer Center
Record last reviewed: May 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002750
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005