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Melphalan in Patients With Neoplastic Meningitis

This study is ongoing, but not recruiting participants.

Sponsored by: Duke University
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002750
  Purpose

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 Intervention Phase
Brain and Central Nervous System Tumors
Extragonadal Germ Cell Tumor
Leukemia
Lymphoma
Metastatic Cancer
Ovarian Cancer
Drug: melphalan
Phase I

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Lymphoma    Meningitis    Ovarian Cancer   

Drug Information available for:   Melphalan    Melphalan hydrochloride    Sarcolysin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   PHASE I STUDY OF INTRATHECAL MELPHALAN IN PATIENTS WITH NEOPLASTIC MENINGITIS

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

Estimated Enrollment:   6
Study Start Date:   December 1992

Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of intrathecal melphalan (L-PAM) in patients with neoplastic meningitis. II. Determine the CSF and serum pharmacokinetics of L-PAM administered via an Ommaya reservoir to these patients.

OUTLINE: This is a dose escalation study. Patients receive melphalan (L-PAM) intrathecally (IT) via lumbar puncture or Ommaya reservoir twice a week for 2 weeks. Cohorts of 3-6 patients receive escalating doses of melphalan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 4 of 6 patients experience dose-limiting toxicity. At least 3 patients receive L-PAM via Ommaya reservoir at the MTD. Patients with objective or significant clinical response may receive additional L-PAM IT once a week for 2 consecutive weeks, every other week for 2 doses, and then monthly thereafter. Patients are followed every 12 weeks for 1 year or until disease progression.

PROJECTED ACCRUAL: A minimum of 3 children and 3 adults per dose level will be accrued for this study.

  Eligibility
Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed malignancy that is metastatic to the 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

PATIENT CHARACTERISTICS: Age: 3 and over Performance status: Karnofsky 60-100% (age 10 and over) OR Lansky 60-100% (age under 10) Life expectancy: At least 8 weeks Hematopoietic: Absolute neutrophil count greater than 1,000/mm3* Platelet count greater than 100,000/mm3* * Lower values allowed with approval of the investigator Hepatic: Bilirubin less than 3.0 mg/dL Renal: Creatinine less than 2 mg/dL Blood urea nitrogen less than 30 mg/dL Electrolytes (including calcium, magnesium, phosphate) normal Other: No active infection Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior systemic chemotherapy within 3 weeks of entry allowed at investigator's discretion At least 3 weeks since prior intrathecal chemotherapy No other concurrent intrathecal chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy to the CNS No concurrent radiotherapy to the CNS Surgery: Not specified

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002750

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

Sponsors and Collaborators
Duke University

Investigators
Study Chair:     Henry S. Friedman, MD     Duke University    
  More Information


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

Study ID Numbers:   CDR0000064684, DUMC-2117-00-11R8, DUMC-1631-96-11R4, DUMC-1728-97-11R5, DUMC-1818-98-11R6, DUMC-1961-99-11R7, NCI-V96-0869
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002750
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent childhood acute lymphoblastic leukemia  
recurrent adult Hodgkin lymphoma  
Waldenstrom macroglobulinemia  
recurrent childhood lymphoblastic lymphoma  
childhood central nervous system germ cell tumor  
recurrent childhood acute myeloid leukemia  
recurrent adult acute myeloid leukemia  
recurrent adult acute lymphoblastic leukemia  
recurrent/refractory childhood Hodgkin lymphoma  
recurrent ovarian germ cell tumor  
recurrent adult non-Hodgkin lymphoma  
recurrent grade 1 follicular lymphoma  
recurrent grade 2 follicular lymphoma  
recurrent grade 3 follicular lymphoma  
recurrent adult diffuse small cleaved cell lymphoma  
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
extragonadal germ cell tumor
leptomeningeal metastases
recurrent childhood small noncleaved cell lymphoma
recurrent childhood large cell lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Study placed in the following topic categories:
Lymphoma, Mantle-Cell
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Urogenital Neoplasms
Central Nervous System Neoplasms
Small non-cleaved cell lymphoma
Lymphoma, large-cell, immunoblastic
Neoplasm Metastasis
Acute myeloid leukemia, adult
Hodgkin Disease
Nervous System Neoplasms
Endocrine Gland Neoplasms
Lymphoma, Large B-Cell, Diffuse
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Leukemia, B-cell, chronic
Genital Neoplasms, Female
Acute myelogenous leukemia
Endocrine System Diseases
Leukemia, Myeloid
Waldenstrom Macroglobulinemia
Hodgkin lymphoma, childhood
B-cell lymphomas
Lymphoma, Non-Hodgkin
Melphalan
Leukemia, Lymphoid
Hodgkin's disease
Gonadal Disorders
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Nervous System Diseases
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on November 20, 2008




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