Intrathecal Mafosfamide

Completed · Phase 1

Conditions studied: Malignant Meningeal Neoplasms

In brief

This research study is an investigational treatment with the experimental drug Mafosfamide. This treatment is only for children with cancer that has spread to the meninges (tissues that cover the spinal column and brain) and has continued to grow despite treatment with standard therapy. Mafosfamide is a drug reported to have antitumor effects in animals and that has been given safely into the cerebrospinal fluid (the fluid within and surrounding the brain) in a small number of children and adults. Since there is limited experience in adults and children in giving mafosfamide in this way, the main purpose of this study is to determine the appropriate safe dose of mafosfamide when given intrathecally, that is directly into the cerebrospinal fluid. The purposes for this study are to (a) determine what dose of mafosfamide can be safely given into the cerebrospinal fluid through an Ommaya reservoir (surgically implanted catheters used to sample cerebrospinal fluid and to instill medication into the cerebrospinal fluid) and lumbar puncture (spinal tap) or lumbar reservoir; (b) look for side effects of drug treatment; (c) to study the pharmacology (how the human body handles the drug) when given directly into the spinal fluid; and (d) see if this drug is beneficial to the patient.

Key facts

Study ID

NCT00062881

Run by

Baylor College of Medicine

People needed

65

Starts

1990-06-01

Expected to finish

2005-09-01

Last updated by the study team

2020-03-04

Who can join

Age: 3 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• Children'sHospital Los Angeles — Los Angeles, California, United States
• Children's Hospital National Medical Center — Washington D.C., District of Columbia, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Pediatric Branch, National Cancer Institute — Bethesda, Maryland, United States
• Mayo Clinic — Rochester, Minnesota, United States
• M.D. Anderson Cancer Center — Houston, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States
• Neurological Research Center — Bennington, Vermont, United States
• Children's Hospital and Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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