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
Lymphoma Leukemia Brain Tumor	Drug: melphalan	Phase I

Further Study Details: 

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

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• 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

--Prior/Concurrent Therapy--

• 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

--Patient Characteristics--

• 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

North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States

Study chairs or principal investigators

Henry S. Friedman,  Study Chair,  Duke Comprehensive Cancer Center   

Study ID Numbers:  CDR0000064684; DUMC-1961-99-11R7; NCI-V96-0869; DUMC-1631-96-11R4; DUMC-1728-97-11R5; DUMC-1818-98-11R6
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