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Phase I Study of Intrathecal Mafosfamide


Phase 1
3 Years
N/A
Not Enrolling
Both
Malignant Meningeal Neoplasms

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Trial Information

Phase I Study of Intrathecal Mafosfamide


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

H3241

NCT ID:

NCT00062881

Start Date:

June 1990

Completion Date:

September 2005

Related Keywords:

  • Malignant Meningeal Neoplasms
  • Cancer
  • Leukemia
  • Lymphoma
  • Solid Tumor
  • Neoplasms
  • Meningeal Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905
Mayo ClinicJacksonville, Florida  32224
M.D. Anderson Cancer CenterHouston, Texas  77030
Texas Children's HospitalHouston, Texas  
Children'sHospital Los AngelesLos Angeles, California  90027
Children's Hospital National Medical CenterWashington, District of Columbia  20010
Children's Healthcare of AtlantaAtlanta, Georgia  30342
Pediatric Branch, National Cancer InstituteBethesda, Maryland  20892
Neurological Research CenterBennington, Vermont  05210
Children's Hospital and Medical CenterSeattle, Washington  98105