Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
65 participants
INTERVENTIONAL
1989-11-30
2003-11-30
Brief Summary
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Mafosfamide will be administered intrathecally on a bi-weekly basis for four weeks, followed by twice monthly administration for four months and then monthly IT administration. A minimum of 9 patients will be studied in each disease category (leukemias, lymphomas, and other malignancies refractory to conventional therapy).
Detailed Description
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Mafosfamide will be administered intrathecally on a bi-weekly basis for four weeks, followed by twice monthly administration for four months and then monthly IT administration. A minimum of 9 patients will be studied in each disease category (leukemias, lymphomas, and other malignancies refractory to conventional therapy).
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Mafosfamide
Eligibility Criteria
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Inclusion Criteria
Diagnosis: Patients with leukemia, lymphoma, or other solid tumor who also have overt meningeal involvement by their tumor. The definition of meningeal disease on this protocol includes:
Leukemia/Lymphoma - CSF cell count greater than or equal to 5/mm(3) AND evidence of blast cells on cytospin preparation or by cytology.
Solid tumors - Presence of tumor cells on cytospin preparation or cytology OR presence of measurable meningeal disease on CT or MRI scans.
Patients must have a life expectancy of at least 8 weeks and an ECOG performance status of 2 or better. Patients who are unable to walk because of paralysis, but who are up in a wheelchair will be considered ambulatory for the purposes of the performance score.
Patients and/or their parents must sign an informed consent indicating that they are aware of the investigational nature of this study.
Patients must have recovered from the acute toxic effects of all prior intrathecal chemotherapy, immunotherapy, or radiotherapy, prior to entering this study and must be without significant systemic illness (e.g. infection). Patients must not have received any CNS therapy within 1 week prior to starting treatment on this study or craniospinal irradiation within 8 weeks prior to starting treatment on this study. Patients must not have received intrathecal chemotherapy within 1 week (2 weeks if prior DTC101).
Patients must not have clinically significant abnormalities with regard to liver function, renal function or metabolic parameters (electrolytes, calcium and phosphorus).
A Durable Power of Attorney (DPA) must be offered to all patients greater than or equal to 18 years of age.
Exclusion Criteria
Patients with clinical evidence of obstructive hydrocephalus or compartmentalization of the CSF flow as documented by a radioisotope Indium(111) or Technitium(99) - DTPA flow study are not eligible for this protocol. If a CSF flow block or compartmentalization is demonstrated, focal radiotherapy to the site of the block to restore flow and a repeat CSF flow study showing clearing of the blockage is required for the patient to be eligible for the study.
Patients who have leukemia or lymphoma and a concomitant bone marrow relapse are not eligible for this study.
Women of childbearing age must not be pregnant or lactating.
Patients who have received any other systemic investigational agent within 14 days prior to, or during, study treatment. The 14 day period should be extended if the patient received any investigational agent which is known to have delayed toxicities after 14 days. Patients must not have received any other intrathecal investigational agent within 7 days prior to, or during, study treatment. The 7 day period should be extended if the patient received any investigational agent which is known to have delayed toxicities after 7 days or a prolonged half-life.
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Locations
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National Cancer Institute (NCI)
Bethesda, Maryland, United States
Countries
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References
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Atassi G, Hilgard P, Pohl J. Antineoplastic activity of ASTA Z 7557 (NSC-345842, INN mafosfamide) on transplantable murine tumors. Invest New Drugs. 1984;2(2):169-73. doi: 10.1007/BF00232347.
Bruntsch U, Groos G, Hiller TA, Wandt H, Tigges FJ, Gallmeier WM. Phase-I study of mafosfamide-cyclohexylamine (ASTA-Z-7557, NSC 345 842) and limited phase-I data on mafosfamide-lysine. Invest New Drugs. 1985;3(3):293-6. doi: 10.1007/BF00179434.
Arndt CA, Colvin OM, Balis FM, Lester CM, Johnson G, Poplack DG. Intrathecal administration of 4-hydroperoxycyclophosphamide in rhesus monkeys. Cancer Res. 1987 Nov 15;47(22):5932-4.
Other Identifiers
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90-C-0095
Identifier Type: -
Identifier Source: secondary_id
900095
Identifier Type: -
Identifier Source: org_study_id
NCT00018928
Identifier Type: -
Identifier Source: nct_alias