L-MTP-PE for High-Risk Osteosarcoma
This study is ongoing, but not recruiting participants.
Sponsor:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00631631
First received: February 29, 2008
Last updated: March 12, 2013
Last verified: March 2013
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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 ]
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | April 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:
- 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.
- 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.)
- Ages 2 < / = 50 years.
- 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 < 2.5 x upper limit of normal (ULN) for age; 2) total bilirubin < / = 1.5 x ULN for age.
- 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.
- 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: Lansky 50-100% (< / = 16 years of age); OR, ECOG 0-2 or Karnofsky 50-100% (>16 years of age).
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
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: | March 12, 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 May 22, 2013