L-MTP-PE Compassion Access for High-Risk Osteosarcoma - Full Text View

Purpose

Primary Objective:

1. To collect information regarding the safety and tolerability of L-MTP-PE.

Secondary Objectives:

To assess outcomes of patients who receive L-MTP-PE.
To evaluate serum concentration-time profiles of free and total L-MTP-PE in 15-20 patients.

Condition	Intervention
Osteosarcoma	Drug: L-MTP-PE

MedlinePlus related topics:

Cancer

Drug Information available for:

Ethanolamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Liposomal Muramyl Tripeptide Phosphatidyl Ethanolamine (L-MTP-PE): Compassionate Access for High-Risk Osteosarcoma

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To provide an investigational drug, liposomal muramyl tripeptide phosphatidyl ethanolamine (L-MTP-PE) alone or combined with recommended approved therapy for treatment of osteosarcoma. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	February 2008
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental L-MTP-PE	Drug: L-MTP-PE 2 mg/m^2 IV over 1 hour twice weekly x 12 weeks; 2 mg/m^2 IV over 1 hour once weekly x 24 weeks.

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Eligibility

Ages Eligible for Study:	2 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed informed consent/assent by the patient or his/her legal guardian. Voluntary participation in the pharmacokinetic portion of the study will be included in the informed consent but not required for study participation.
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.)
2 < / = 50 years of age (age of disease being treated).
Adequate hematopoietic function as demonstrated by: 1) Absolute Neutrophil Count (ANC) > 750/microL; Hemoglobin (Hb) > 8 g/dL; Platelets > 30,000/microL.
Adequate hepatic function as documented by: 1) ALT <100; 2) Bilirubin <2. [Note: elevation of alkaline phosphatase is not a contraindication to enrollment as this is common in relapsed osteosarcoma.]
Adequate renal function as demonstrated by creatinine < / = 2.5
Absence of concurrent active acute infection (i.e., afebrile).
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).
Performance status ECOG 0-1

Exclusion Criteria:

Chronic use of corticosteroids or other immunosuppressive agents.
Patients who are pregnant or breast-feeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631631

Contacts


Contact: Peter M. Anderson, MD, PhD	713-792-6620

Locations


United States, New York
	Memorial Sloan-Kettering Cancer Center	Not yet recruiting
	New York, New York, United States, 10065

United States, Texas
	U.T.M.D. Anderson Cancer Center	Recruiting
	Houston, Texas, United States, 77030
	Principal Investigator: Peter M. Anderson, MD, PhD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators


Principal Investigator:	Peter M. Anderson, MD, PhD	U.T.M.D. Anderson Cancer Center

More Information

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Peter M. Anderson, MD, PhD/Professor )
Study ID Numbers:	2007-0869
First Received:	February 29, 2008
Last Updated:	February 29, 2008
ClinicalTrials.gov Identifier:	NCT00631631
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Osteosarcoma

Bone Cancer

L-MTP-PE

Compassionate Access

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue

Bone Neoplasms

Malignant mesenchymal tumor

Bone neoplasms

Acetylmuramyl-Alanyl-Isoglutamine

Sarcoma

Osteosarcoma

MuramylNAc-Ala-isoGln-Lys-tripeptide-PE

Osteogenic sarcoma

Soft tissue sarcomas

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Neoplasms, Bone Tissue

Immunologic Factors

Physiological Effects of Drugs

Adjuvants, Immunologic

Neoplasms, Connective Tissue

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00631631