Intrathecal Mafosfamide
Malignant Meningeal Neoplasms
About this trial
This is an interventional treatment trial for Malignant Meningeal Neoplasms focused on measuring Cancer, Leukemia, Lymphoma, Solid Tumor
Eligibility Criteria
Over 3 years of age with meningeal malignancies that are progressive or refractory to conventional therapy. Patients with meningeal malignancies secondary to an underlying solid tumor are eligible at initial diagnosis if there is no conventional therapy. Patients with leukemia, lymphoma, or other solid tumor who also have overt meningeal involvement by their tumor. Must have a life expectancy of at least 8 weeks and an ECOG performance status of 2 or better. 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). Must not have clinically significant abnormalities with regard to liver function, renal function or metabolic parameters (electrolytes, calcium and phosphorus). Durable Power of Attorney (DPA): A DPA must be offered to all patients ≥ 18 years of age. Exclusion Criteria: Receiving other therapy (either intrathecal or systemic) designed specifically to treat their meningeal malignancy are not eligible for this study. However, patients receiving concomitant chemotherapy to control systemic or bulk CNS disease will be eligible, provided the systemic chemotherapy is not a phase I agent, an agent which significantly penetrates the CNS (e.g., high dose methotrexate, (> 1 gm/m2), thiotepa, high dose cytarabine, (> 2 gm/m2 per day), 5-fluorouracil, intravenous 6-mercaptopurine or topotecan), or an agent known to have serious unpredictable CNS side effects. Clinical evidence of obstructive hydrocephalus or compartmentalization of the CSF flow as documented by a radioisotope Indium111 or Technitium99-DTPA flow study are not eligible for this protocol. If a CSF flow block or compartmentalization is demonstrated, focal radiotherapy to the site of 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. Women of childbearing age must not be pregnant or lactating. Patients must not 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 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.
Sites / Locations
- Children'sHospital Los Angeles
- Children's Hospital National Medical Center
- Mayo Clinic
- Children's Healthcare of Atlanta
- Pediatric Branch, National Cancer Institute
- Mayo Clinic
- M.D. Anderson Cancer Center
- Texas Children's Hospital
- Neurological Research Center
- Children's Hospital and Medical Center