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Home > "M" Clinical Trials Conditions > Melphalan in Patients With Neoplastic Meningitis  Melphalan in Patients With Neoplastic Meningitis
Melphalan in Patients With Neoplastic Meningitis
For Condition: Lymphoma,Leukemia,Brain Tumor
Status: No longer recruiting
Sponsor(s): Duke Comprehensive Cancer Center ,
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Years/
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HenryFriedman, Study Chair, Duke Comprehensive Cancer Center
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Additional Information:
Study ID Numbers: CDR0000064684; DUMC-1961-99-11R7,NCI-V96-0869,DUMC-1631-96-11R4,DUMC-1728-97-11R5,DUMC-1818-98-11R6
Study Start Date: December 1992
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002750
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3. High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors
4. Genetic Study in Patients Receiving Treatment for Hodgkin's Disease or Childhood Brain Tumor
5. Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor
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Melphalan in Patients With Neoplastic Meningitis
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