Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-31 @ 3:46 PM
Study NCT ID:
NCT00002750
Status:
COMPLETED
Last Update Posted:
2013-02-20
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Melphalan in Patients With Neoplastic Meningitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D008258', 'term': 'Waldenstrom Macroglobulinemia'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D016400', 'term': 'Lymphoma, Large-Cell, Immunoblastic'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D055756', 'term': 'Meningeal Carcinomatosis'}, {'id': 'D054739', 'term': 'Dendritic Cell Sarcoma, Interdigitating'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D015620', 'term': 'Histiocytic Disorders, Malignant'}, {'id': 'D015614', 'term': 'Histiocytosis'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D002908', 'term': 'Chronic Disease'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008558', 'term': 'Melphalan'}], 'ancestors': [{'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1992-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2001-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-15', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-05-21', 'lastUpdatePostDateStruct': {'date': '2013-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-05', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['recurrent childhood acute lymphoblastic leukemia', 'recurrent adult Hodgkin lymphoma', 'Waldenström 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'], 'conditions': ['Brain and Central Nervous System Tumors', 'Extragonadal Germ Cell Tumor', 'Leukemia', 'Lymphoma', 'Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: Phase I trial to study the effectiveness of melphalan in patients with persistent or recurrent neoplastic meningitis.', 'detailedDescription': '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.\n\nOUTLINE: 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.\n\nPROJECTED ACCRUAL: A minimum of 3 children and 3 adults per dose level will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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\n\nPATIENT 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\n\nPRIOR 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"}, 'identificationModule': {'nctId': 'NCT00002750', 'briefTitle': 'Melphalan in Patients With Neoplastic Meningitis', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Phase I of Intrathecal Melphalan in Patients With Recurrent Neoplastic Meningitis', 'orgStudyIdInfo': {'id': '2117'}, 'secondaryIdInfos': [{'id': 'DUMC-2117-00-11R8'}, {'id': 'DUMC-1631-96-11R4'}, {'id': 'DUMC-1728-97-11R5'}, {'id': 'DUMC-1818-98-11R6'}, {'id': 'DUMC-1961-99-11R7'}, {'id': 'NCI-V96-0869'}, {'id': 'CDR0000064684', 'type': 'OTHER', 'domain': 'NCI'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'melphalan', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Comprehensive Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Henry S. Friedman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Duke Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}