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Liposomal Muramyl Tripeptide Phosphatidyl Ethanolamine (L-MTP-PE) for High-risk Osteosarcoma

2 Years
50 Years
Not Enrolling

Thank you

Trial Information

Liposomal Muramyl Tripeptide Phosphatidyl Ethanolamine (L-MTP-PE) for High-risk Osteosarcoma

The Study Drug:

L-MTP-PE is a solution of very small fat particles designed to activate or boost the body's
white blood cells to fight tumors.

Additional Therapy:

You may receive other therapy while on L-MTP-PE, as needed. You may also be eligible to
receive drugs in combination with L-MTP-PE, surgery, radiation, or a therapy using heat or
cold to kill lesions. Hospital admission is not required. Your doctor will describe these
options to you in more detail.

Screening Tests:

Before you can start treatment on this study, you will have what are called "screening
tests." These tests will help the doctor decide if you are eligible to take part in this
study. These exams, tests, or procedures are part of regular cancer care and may be done
even if you do not join this study. If you have had some of them recently, they may not need
to be repeated. This decision will be up to your study doctor.

- Your medical history will be recorded.

- You will have a physical exam, including measurement of vital signs (blood pressure,
heart rate, temperature, and breathing rate).

- You will be asked how well you are able to perform the normal activities of daily
living (performance status evaluation).

- Blood (about 2-3 teaspoons) will be drawn for routine tests and tests of your kidney
and liver function. This routine blood draw will include a pregnancy test for women who
are able to have children. To take part in this study, the pregnancy test must be

- You will have computed tomography (CT) scans, magnetic resonance imaging (MRI) scans,
bone scans, and/or positron emission tomography (PET) scans to check the status of the

Central Venous Catheter Placement:

If you do not already have a central venous catheter (CVC), you may need to have one placed.
A CVC is a sterile, flexible tube with a needle that will be placed into a large vein in
your chest during a short operation. You will be given anesthesia to make you sleep during
the procedure, and you will get pain medication afterward. The CVC will be used to draw
blood and give the investigational drug and other therapy more easily. It stays in all the
time, so you will have fewer "needle sticks" during these procedures. Your doctor will
explain the CVC placement procedure to you in more detail, and you will be asked to sign a
separate consent form for this procedure.

Study Treatments:

If you are found to be eligible to take part in this study, you will receive L-MTP-PE by
vein over 1 hour 2 times a week, at least 3 days apart, for 12 weeks (3 months). You will
then receive L-MTP-PE 1 time a week for the next 24 weeks (6 months).

All participants will receive the same dose of L-MTP-PE typically on an outpatient basis.
After the first dose, some participants may be able to get L-MTP-PE at a participating
center not in the Houston area and closer to their home.

You will receive Advil (ibuprofen) by mouth before each dose of L-MTP-PE to reduce the risk
of fever. If fevers occur, then both ibuprofen and Tylenol (acetaminophen) will be taken
before the next dose of L-MTP-PE. Your temperature will be monitored after the infusion
for 30 minutes and then you will be allowed to go home.

If needed, you may receive additional FDA-approved drugs to help reduce the risk of nausea
and vomiting before receiving L-MTP-PE.

If you experience side effects, your doctor will discuss how best to control these. If
necessary, the L-MTP-PE treatment may be postponed.

Study Visits:

During the study, the following procedures will be performed when your doctor thinks it is

- Your medical history will be recorded.

- You will have a physical exam, including measurement of vital signs.

- Blood (about 2-3 teaspoons) will be drawn for routine tests and tests of your kidney
and liver function.

- You will have CT scans, MRIs, bone scans, and/or PET scans to check the status of the


You may remain on treatment for up to 9 months. You will be taken off early if the disease
gets worse or intolerable side effects occur.

Follow-up Visits:

- You will have follow-up visits every 3 months after the last dose of the study drug (or
more or less frequently as determined by your study doctor). At these visits, the
following tests and procedures will be performed:

- You will have a physical exam, including measurement of your vital signs.

- Your medical history will be recorded.

- You will have CT scans, MRIs, bone scans, and/or PET scans to check the status of the

- You will be asked about any drugs you may be taking and side effects you may be

This is an investigational study. L-MTP-PE is not FDA approved or commercially available.
At this time, L-MTP-PE is only being used in research.

If it becomes commercially available while you are on study, this study will be closed.

Up to 100 patients will take part in this study. Up to 50 will be enrolled at M. D.

Inclusion Criteria:

1. Signed informed consent/assent by the patient or his/her legal guardian. Voluntary
participation in the pharmacokinetic portion of the compassionate access protocol
will be included in the informed consent but not required for compassionate use

2. Documented diagnosis of high grade osteosarcoma in patients with relapsed or
recurrent disease, locally or metastatic, with disease not completely resectable or
who are unable to complete recommended chemotherapy due to toxicity: Relapse,
recurrence local or metastatic; unable to have standard surgical resection;
abbreviated chemotherapy regimen secondary to toxicity (e.g. hypophosphatemia from
ifosfamide, cardiotoxicity from doxorubicin, renal dysfunction from methotrexate,
ifosfamide, or cisplatin.)

3. Ages 2 < / = 50 years.

4. Adequate hematopoietic function as demonstrated by: 1) Absolute Neutrophil Count
(ANC) > 750/microL; Hemoglobin (Hb) > 8 g/dL; Platelets > 30,000/microL.

5. Adequate hepatic function as documented by 1) ALT < 2.5 x upper limit of normal (ULN)
for age; 2) total bilirubin < / = 1.5 x ULN for age.

6. Adequate renal function as demonstrated by: 1) Creatinine clearance or radioisotope
glomerular filtration rate > 70 mL/min/1.73 m^2; OR, 2) Serum creatinine < / = 2x ULN
for age.

7. Absence of concurrent active acute infection (i.e., afebrile).

8. In females of child bearing potential (not menopausal for 12 months or no previous
surgical sterilization), negative pregnancy test. All sexually active subjects will
use an effective means of contraception. Such means include oral contraceptives,
Lupron Depot, DepoProvera, and condom with diaphragm and spermicidal jelly).

9. Performance status: Lansky 50-100% (< / = 16 years of age); OR, ECOG 0-2 or Karnofsky
50-100% (>16 years of age).

Exclusion Criteria:

1. Chronic use of corticosteroids or other immunosuppressive agents.

2. Patients who are pregnant or breast-feeding.

Type of Study:


Study Design:

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

Outcome Measure:

Number of adverse events

Outcome Time Frame:

12 months or disease progression, whichever occurs first

Safety Issue:


Principal Investigator

Peter M. Anderson, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2008

Completion Date:

May 2013

Related Keywords:

  • Osteosarcoma
  • Osteosarcoma
  • Bone Cancer
  • L-MTP-PE
  • Compassionate Access
  • Osteosarcoma



Memorial Sloan-Kettering Cancer Center New York, New York  10021
U.T.M.D. Anderson Cancer Center Houston, Texas  77030