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Expanded Access Use of L-MTP-PE for the Treatment of Osteosarcoma

Primary Purpose

Osteosarcoma

Status
Available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
L-MTP-PE
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Osteosarcoma focused on measuring L-MTP-PE, Expanded Access, 20-324

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Confirmed diagnosis of osteosarcoma of any age Note: Patients with either newly diagnosed or relapsed osteosarcoma are eligible.
  • Surgical resection or other definitive local control therapy of all clinically detectable sites of osteosarcoma
  • L-MTP-PE is deemed to be of potential benefit by the treating investigator
  • Willing and able to understand and sign informed consent and assent as appropriate
  • Life expectancy > 6 weeks
  • Adequate organ function as follows:

  • Adequate bone marrow function defined as:

    • absolute neutrophil count (ANC) ≥ 750/mm^3
    • platelet count ≥ 30,000/ mm^3
    • hemoglobin ≥ 8 g/dl

  • Adequate renal function defined as:

    • Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min/1.73m^2 OR
    • Serum creatinine ≤ 2x the upper limit of normal based on age/gender

  • Adequate liver function defined as:

    • Bilirubin (sum of conjugated + unconjugated) ≤ 2x upper limit of normal for age or ≤ 4x upper limit of normal if thought to have Gilbert's disease
    • AST or ALT ≤ 3x upper limit of normal or ≤ 5x upper limit of normal for patients with liver metastases
  • Willing to use a barrier method of contraception throughout the course of the study and for 1 year after participation if relevant

Exclusion Criteria:

  • Use of chronic steroids of other immunosuppressive agents
  • Pregnant or breast feeding

Sites / Locations

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 16, 2020
Last Updated
May 19, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04571229
Brief Title
Expanded Access Use of L-MTP-PE for the Treatment of Osteosarcoma
Official Title
Expanded Access Use of L-MTP-PE for the Treatment of Osteosarcoma
Study Type
Expanded Access

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

Brief Summary
This expanded access protocol will allow access to treatment with L-MTP-PE for people with osteosarcoma. L-MTP-PE is an investigational drug that has not been approved by the FDA to treat any condition, including osteosarcoma. L-MTP-PE works by activating certain types of white blood cells, and these active white blood cells help the immune system kill cancer cells.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteosarcoma
Keywords
L-MTP-PE, Expanded Access, 20-324

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
L-MTP-PE
Intervention Description
L-MTP-PE will be administered at a dose of 2mg/m2 (maximum dose 4 mg), twice weekly for 12 weeks and weekly for an additional 24 weeks, for a total of 48 doses in 36 weeks.

10. Eligibility

Sex
All
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of osteosarcoma of any age Note: Patients with either newly diagnosed or relapsed osteosarcoma are eligible. Surgical resection or other definitive local control therapy of all clinically detectable sites of osteosarcoma L-MTP-PE is deemed to be of potential benefit by the treating investigator Willing and able to understand and sign informed consent and assent as appropriate Life expectancy > 6 weeks Adequate organ function as follows: Adequate bone marrow function defined as: absolute neutrophil count (ANC) ≥ 750/mm^3 platelet count ≥ 30,000/ mm^3 hemoglobin ≥ 8 g/dl Adequate renal function defined as: Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min/1.73m^2 OR Serum creatinine ≤ 2x the upper limit of normal based on age/gender Adequate liver function defined as: Bilirubin (sum of conjugated + unconjugated) ≤ 2x upper limit of normal for age or ≤ 4x upper limit of normal if thought to have Gilbert's disease AST or ALT ≤ 3x upper limit of normal or ≤ 5x upper limit of normal for patients with liver metastases Willing to use a barrier method of contraception throughout the course of the study and for 1 year after participation if relevant Exclusion Criteria: Use of chronic steroids of other immunosuppressive agents Pregnant or breast feeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Slotkin, MD
Phone
212-639-8856
Email
slotkine@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Meyers, MD
Phone
212-639-5952
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Slotkin, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Slotkin, MD
Phone
212-639-8856
First Name & Middle Initial & Last Name & Degree
Paul Meyers, MD
Phone
212-639-5952
First Name & Middle Initial & Last Name & Degree
Emily Slotkin, MD

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

Expanded Access Use of L-MTP-PE for the Treatment of Osteosarcoma

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