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Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma

Primary Purpose

Recurrent Osteosarcoma

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

humanized anti-GD2 antibody

GM-CSF

About this trial

This is an interventional treatment trial for Recurrent Osteosarcoma focused on measuring Humanized Monoclonal Antibody 3F8 (Hu3F8), Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), 15-096

Eligibility Criteria

13 Months - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients must have recurrent OS. OS must be verified by histopathology review by the site's Department of Pathology. (Patients registered at MSK must have pathology confirmed by MSK Department of Pathology.)
Patients must be in a ≥2nd complete remission as indicated by appropriate radiologic evaluations at the time of study entry.
Patients must be ≥ 1 year of age and ≤ to 40 years of age at the time of enrollment.
Prior therapy: ≥3 weeks should have elapsed since last cytotoxic therapy, immunotherapy or radiation therapy. More than one week should have elapsed since major surgery.

NOTE: Minor surgery (e.g. minor biopsy, central venous catheter placement, shunt revision) is permitted within 1 week prior to enrollment)

Adequate hematopoietic function defined as:
- Absolute neutrophil count ≥ 500/ul
- Absolute lymphocyte count ≥ 500/ul
- Platelet count ≥ 50,000/ul (transfusion independent)
Adequate hepatic function as defined by:
- Total bilirubin of ≤ 1.5 times upper limit of normal (exception is made for patients with Gilbert's syndrome who may be considered eligible if total bilirubin is ≤ 3 times upper limit of normal).
- AST (SGOT) of ≤ 3 times upper limit of normal
- ALT (SGPT) of ≤ 3 times upper limit of normal
Adequate renal function as defined by a serum creatinine of ≤ 1.5 times upper limit of normal
Adequate cardiac function as defined by a shortening fraction of ≥ 28% or an ejection fraction ≥ 50%
Adequate pulmonary function as defined by no evidence of dyspnea at rest at no history of exercise intolerance
Adequate performance status as defined by ECOG score of ≤ 2 or Karnofsky/Lansky score ≥ 50%
Prior treatment with other anti-GD2 antibodies is allowed (prior treatment with Hu3F8 is NOT allowed), but HAHA antibody titer must be negative
Women of child-bearing potential must be willing to practice an effective method of birth control while on treatment
Signed informed consent indicating awareness of the investigational nature of this program

Exclusion Criteria:

Patients with OS in first complete remission.
Presence of overt metastatic disease at any site.
Active life-threatening infection.
Pregnant women or women who are breast-feeding.
Inability to comply with protocol requirements.

Sites / Locations

Children's Hospital of Los Angeles (Data Collection Only)Recruiting
Memorial Sloan Kettering Cancer CenterRecruiting
MD ANDERSON CANCER CENTER (Data Collection Only)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

humanized anti-GD2 antibody, hu3F8, when combined with GM-CSF

Arm Description

One cycle consists of treatment with hu3F8 at a dose of 2.4mg/kg/dose for 3 days (day 1, 3, and 5) in the presence of subcutaneous (sc) GM-CSF (day -4 through 5). These 3 doses of hu3F8 and 10 days of GM-CSF constitute a treatment cycle. Cycles are repeated at ~2-4 week intervals between first days of hu3F8, through 5 cycles. A maximum of 5 cycles will be administered on protocol. If elevations of amylase and/or lipase (>Grade 1) or clinical signs suggestive of pancreatitis (e.g. upper abdominal pain) occurs, naxitamab and GM-CSF doses should be held until improvement of toxicity to ≤Grade 1 if laboratory elevations and/or pancreatitis is possibly related to either naxitamab or GM-CSF.

Outcomes

Primary Outcome Measures

event free survival (EFS)

EFS is defined as the time from surgery to relapse or death from any cause, recurrence of tumor or second malignancy.

Secondary Outcome Measures

time to recurrence

Time to recurrence will be estimated using Kaplan-Meier methods. Very few patients are expected to die without relapse (<5%). Recurrence is defined as the radiographic presence of any new lesion that is not attributable to differences in scanning techniques, change in imaging modality or findings thought to represent something other than osteosarcoma, or if a biopsy is performed which shows osteosarcoma.

Full Information

NCT ID

NCT02502786

First Posted

July 16, 2015

Last Updated

August 7, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Children's Hospital Los Angeles, M.D. Anderson Cancer Center, Y-mAbs Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT02502786

Brief Title

Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma

Official Title

A Phase II Study of Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 2015 (undefined)

Primary Completion Date

July 2025 (Anticipated)

Study Completion Date

July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Children's Hospital Los Angeles, M.D. Anderson Cancer Center, Y-mAbs Therapeutics

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to find out what effect an antibody called Humanized 3F8 (Hu3F8) and a drug called GM-CSF have on the patient and whether it can keep the patient in remission longer and/or prevent recurrence of the disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Osteosarcoma

Keywords

Humanized Monoclonal Antibody 3F8 (Hu3F8), Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), 15-096

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

humanized anti-GD2 antibody, hu3F8, when combined with GM-CSF

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

humanized anti-GD2 antibody

Other Intervention Name(s)

hu3F8

Intervention Type

Drug

Intervention Name(s)

GM-CSF

Primary Outcome Measure Information:

Title

event free survival (EFS)

Description

EFS is defined as the time from surgery to relapse or death from any cause, recurrence of tumor or second malignancy.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

time to recurrence

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Months

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must have recurrent OS. OS must be verified by histopathology review by the site's Department of Pathology. (Patients registered at MSK must have pathology confirmed by MSK Department of Pathology.) Patients must be in a ≥2nd complete remission as indicated by appropriate radiologic evaluations at the time of study entry. Patients must be ≥ 1 year of age and ≤ to 40 years of age at the time of enrollment. Prior therapy: ≥3 weeks should have elapsed since last cytotoxic therapy, immunotherapy or radiation therapy. More than one week should have elapsed since major surgery. NOTE: Minor surgery (e.g. minor biopsy, central venous catheter placement, shunt revision) is permitted within 1 week prior to enrollment) Adequate hematopoietic function defined as: Absolute neutrophil count ≥ 500/ul Absolute lymphocyte count ≥ 500/ul Platelet count ≥ 50,000/ul (transfusion independent) Adequate hepatic function as defined by: Total bilirubin of ≤ 1.5 times upper limit of normal (exception is made for patients with Gilbert's syndrome who may be considered eligible if total bilirubin is ≤ 3 times upper limit of normal). AST (SGOT) of ≤ 3 times upper limit of normal ALT (SGPT) of ≤ 3 times upper limit of normal Adequate renal function as defined by a serum creatinine of ≤ 1.5 times upper limit of normal Adequate cardiac function as defined by a shortening fraction of ≥ 28% or an ejection fraction ≥ 50% Adequate pulmonary function as defined by no evidence of dyspnea at rest at no history of exercise intolerance Adequate performance status as defined by ECOG score of ≤ 2 or Karnofsky/Lansky score ≥ 50% Prior treatment with other anti-GD2 antibodies is allowed (prior treatment with Hu3F8 is NOT allowed), but HAHA antibody titer must be negative Women of child-bearing potential must be willing to practice an effective method of birth control while on treatment Signed informed consent indicating awareness of the investigational nature of this program Exclusion Criteria: Patients with OS in first complete remission. Presence of overt metastatic disease at any site. Active life-threatening infection. Pregnant women or women who are breast-feeding. Inability to comply with protocol requirements.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Filemon Dela Cruz, MD

Phone

646-888-2275

First Name & Middle Initial & Last Name or Official Title & Degree

Tara O'Donohue, MD

Phone

212-639-5557

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Filemon Dela Cruz, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital of Los Angeles (Data Collection Only)

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fariba Navid, MD

Phone

323-660-2450

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Filemon Dela Cruz, MD

Phone

646-888-2275

First Name & Middle Initial & Last Name & Degree

Tara O'Donohue, MD

Phone

212-639-5557

First Name & Middle Initial & Last Name & Degree

Filemon Dela Cruz, MD

Facility Name

MD ANDERSON CANCER CENTER (Data Collection Only)

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Douglas Harrison, MD

Phone

713-456-5995

12. IPD Sharing Statement

Citations:

PubMed Identifier

31401903

Citation

Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.

Results Reference

derived

Links:

URL

https://www.mskcc.org/

Description

Memorial Sloan Kettering Cancer Center

Learn more about this trial

Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma

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