Malignant Meningeal Neoplasms Clinical Trial
Official title:
Phase I Study of Intrathecal Mafosfamide
| Verified date | March 2020 |
| Source | Baylor College of Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 65 |
| Est. completion date | September 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 3 Years and older |
| Eligibility |
- 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Children's Healthcare of Atlanta | Atlanta | Georgia |
| United States | Neurological Research Center | Bennington | Vermont |
| United States | Pediatric Branch, National Cancer Institute | Bethesda | Maryland |
| United States | M.D. Anderson Cancer Center | Houston | Texas |
| United States | Texas Children's Hospital | Houston | Texas |
| United States | Mayo Clinic | Jacksonville | Florida |
| United States | Children'sHospital Los Angeles | Los Angeles | California |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | Children's Hospital and Medical Center | Seattle | Washington |
| United States | Children's Hospital National Medical Center | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Baylor College of Medicine |
United States,