L-MTP-PE for High-Risk Osteosarcoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00631631
First received: February 29, 2008
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

Primary Objective:

-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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Liposomal Muramyl Tripeptide Phosphatidyl Ethanolamine (L-MTP-PE) for High-risk Osteosarcoma

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Number of adverse events [ Time Frame: 12 months or disease progression, whichever occurs first ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum concentration-time profiles of free and total L-MTP-PE in 15-20 patients [ Time Frame: Just before the start of the first infusion of L-MTP-PE and at 0.5, 1, 2, 4, 6 and, 24 hours following the start of the first infusion and just prior to the 2nd dose of L-MTP-PE ] [ Designated as safety issue: No ]
  • Patients with overall survival [ Time Frame: From date of enrollment to date of death ] [ Designated as safety issue: No ]
  • Patients with progression free survival [ Time Frame: From date of enrollment to date of first documented disease progression or death ] [ Designated as safety issue: No ]

Enrollment: 205
Study Start Date: January 2008
Study Completion Date: May 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Other Name: Liposomal Muramyl Tripeptide Phosphatidyl Ethanolamine

  Show Detailed Description

  Eligibility

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

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 participation.
  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631631

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Principal Investigator: Peter M. Anderson, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00631631     History of Changes
Other Study ID Numbers: MTP-OS-403
Study First Received: February 29, 2008
Last Updated: June 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Millennium Pharmaceuticals, Inc.:
Osteosarcoma
Bone Cancer
L-MTP-PE
Compassionate Access

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
MuramylNAc-Ala-isoGln-Lys-tripeptide-PE
Acetylmuramyl-Alanyl-Isoglutamine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 20, 2014