Intrathecal Mafosfamide
Phase I Study of Intrathecal Mafosfamide
2 other identifiers
interventional
65
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 1990
Longer than P75 for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 1990
CompletedFirst Submitted
Initial submission to the registry
June 17, 2003
CompletedFirst Posted
Study publicly available on registry
June 18, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedMarch 4, 2020
March 1, 2020
June 17, 2003
March 2, 2020
Conditions
Keywords
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Children'sHospital Los Angeles
Los Angeles, California, 90027, United States
Children's Hospital National Medical Center
Washington D.C., District of Columbia, 20010, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342, United States
Pediatric Branch, National Cancer Institute
Bethesda, Maryland, 20892, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Neurological Research Center
Bennington, Vermont, 05210, United States
Children's Hospital and Medical Center
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Pediatrics-Hema & Oncology
Study Record Dates
First Submitted
June 17, 2003
First Posted
June 18, 2003
Study Start
June 1, 1990
Study Completion
September 1, 2005
Last Updated
March 4, 2020
Record last verified: 2020-03