Malignant Meningeal NeoplasmsPhase 1NCT00062881
Intrathecal Mafosfamide
A Phase 1 study testing Intrathecal Mafosfamide in people with Malignant Meningeal Neoplasms, run by Baylor College of Medicine at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Malignant Meningeal Neoplasms
- What is being tested?
- Intrathecal Mafosfamide
- How many people
- 65 participants
- Where
- 10 sitesUnited States
- Study dates
- Jun 1990to Sep 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
Neurological Research Center
Bennington, Vermont, 05210
Pediatric Branch, National Cancer Institute
Bethesda, Maryland, 20892
M.D. Anderson Cancer Center
Houston, Texas, 77030
Texas Children's Hospital
Houston, Texas, 77030
Mayo Clinic
Jacksonville, Florida, 32224
Children'sHospital Los Angeles
Los Angeles, California, 90027
Mayo Clinic
Rochester, Minnesota, 55905
Children's Hospital and Medical Center
Seattle, Washington, 98105
Children's Hospital National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Phase I Study of Intrathecal Mafosfamide
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.
Read the detailed description
Mafosfamide is given directly into the cerebrospinal fluid twice a week for six successive weeks. If after six weeks the disease has not shown any evidence of progression (tumor growth) patients will continue to receive intrathecal (I.T.) mafosfamide once a week for one month, followed by twice monthly (every other week) for four months, followed by once a month. Patients may continue to receive mafosfamide as long as unacceptable side effects do not occur and there is no growth of the tumor.
Patients will have a weekly physical exam and blood tests. The cerebrospinal fluid will be tested each time they receive drug for the presence of cancer cells. If the patient has an Ommaya reservoir (a surgically implanted catheter that is used to sample cerebrospinal fluid from the fluid chambers in the head and to install medication into the cerebrospinal fluid) then the doctor may recommend that they receive one dose of mafosfamide through the Ommaya reservoir and the next dose via lumbar puncture (spinal tap) or lumbar reservoir. A lumbar reservoir is a catheter that is surgically implanted into the lower back. This catheter is used to sample cerebrospinal fluid and to install medication into the cerebrospinal fluid.
All patients must be observed for a minimum of eight hours after the first dose of intrathecal mafosfamide. If the first dose is well tolerated (there are no major side effects), further doses of mafosfamide will be administered with close observation for at least two hours after administration during the first six weeks of drug administration. Administration of the mafosfamide and sampling of the cerebrospinal fluid from the Ommaya reservoir, lumbar reservoir, or spinal tap takes about 30 minutes. In addition, after mafosfamide has been given by lumbar puncture, patients must remain lying down on their stomach for one hour.
In patients who have Ommaya reservoirs or lumbar catheters, samples of spinal fluid will be taken from the reservoirs following the first two doses of mafosfamide. For each series of tests, a total of eight spinal fluid samples will be taken with a needle from the Ommaya reservoir over a period of 24 hours after the dose. A spinal tap will be also be performed two hours after the dose on these two days. If you have a lumbar reservoir, eight spinal fluid samples will be taken with a needle from the Ommaya reservoir, over a period of 24 hours after the dose. These samples of cerebrospinal fluid will be used to measure the amount of mafosfamide found in the cerebrospinal fluid at the time they are drawn. This will help us understand how the body handles mafosfamide.
For patients with leukemia, a bone marrow aspiration (taking some bone marrow out of the pelvis bone) is necessary before receiving intrathecal mafosfamide. This is to make sure that there is no cancer in the bone marrow.
- Conditions
- Malignant Meningeal Neoplasms
- Being tested
- Intrathecal Mafosfamide
- Keywords
- Cancer, Leukemia, Lymphoma, Solid Tumor
- Medical subject headings
- Meningeal Neoplasms, Neoplasms, Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal MafosfamideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2003 (estimated)
- Study startJun 1990
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Meningeal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Blaney, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00062881
- Sponsor's protocol ID
- H3241
- Other IDs
- I.T. Mafosfamide
- Status last verified
- Mar 2020
- First submitted
- 17 Jun 2003
- Last updated
- 4 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Intrathecal Mafosfamide
- ClinicalTrials.gov ID
- NCT00062881
- Acronym / sponsor ID
- H3241
- Conditions
- Malignant Meningeal Neoplasms
- Keywords
- Cancer, Leukemia, Lymphoma, Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Jun 1990
- Study completion
- Sep 2005
- First posted
- 18 Jun 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Mafosfamide is given directly into the cerebrospinal fluid twice a week for six successive weeks. If after six weeks the disease has not shown any evidence of progression (tumor growth) patients will continue to receive intrathecal (I.T.) mafosfamide once a week for one month, followed by twice monthly (every other week) for four months, followed by once a month. Patients may continue to receive mafosfamide as long as unacceptable side effects do not occur and there is no growth of the tumor.
Patients will have a weekly physical exam and blood tests. The cerebrospinal fluid will be tested each time they receive drug for the presence of cancer cells. If the patient has an Ommaya reservoir (a surgically implanted catheter that is used to sample cerebrospinal fluid from the fluid chambers in the head and to install medication into the cerebrospinal fluid) then the doctor may recommend that they receive one dose of mafosfamide through the Ommaya reservoir and the next dose via lumbar puncture (spinal tap) or lumbar reservoir. A lumbar reservoir is a catheter that is surgically implanted into the lower back. This catheter is used to sample cerebrospinal fluid and to install medication into the cerebrospinal fluid.
All patients must be observed for a minimum of eight hours after the first dose of intrathecal mafosfamide. If the first dose is well tolerated (there are no major side effects), further doses of mafosfamide will be administered with close observation for at least two hours after administration during the first six weeks of drug administration. Administration of the mafosfamide and sampling of the cerebrospinal fluid from the Ommaya reservoir, lumbar reservoir, or spinal tap takes about 30 minutes. In addition, after mafosfamide has been given by lumbar puncture, patients must remain lying down on their stomach for one hour.
In patients who have Ommaya reservoirs or lumbar catheters, samples of spinal fluid will be taken from the reservoirs following the first two doses of mafosfamide. For each series of tests, a total of eight spinal fluid samples will be taken with a needle from the Ommaya reservoir over a period of 24 hours after the dose. A spinal tap will be also be performed two hours after the dose on these two days. If you have a lumbar reservoir, eight spinal fluid samples will be taken with a needle from the Ommaya reservoir, over a period of 24 hours after the dose. These samples of cerebrospinal fluid will be used to measure the amount of mafosfamide found in the cerebrospinal fluid at the time they are drawn. This will help us understand how the body handles mafosfamide.
For patients with leukemia, a bone marrow aspiration (taking some bone marrow out of the pelvis bone) is necessary before receiving intrathecal mafosfamide. This is to make sure that there is no cancer in the bone marrow.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrathecal Mafosfamide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
Related trials for Malignant Meningeal Neoplasms
RecruitingEarly Phase 1
Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures
Meningioma, Glioblastoma
RecruitingPhase 2
Regorafenib for Recurrent Meningioma (MIRAGE Trial)
Meningioma, Malignant
RecruitingObservational study
Patient Perceptions Around Quality of Care Through Telemedicine in Neuro-Oncology
Central Nervous System Neoplasm, Leptomeningeal Neoplasm
Recruiting
Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma
Meningioma, Meningioma, Malignant
RecruitingPhase 3
Testing Proton Craniospinal Radiation Therapy Versus the Usual Radiation Therapy for Leptomeningeal Metastasis, RADIATE-LM Trial
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intrathecal Mafosfamide in people with Malignant Meningeal Neoplasms, run by Baylor College of Medicine at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.