Clinical trial NCT02502786: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Recurrent Osteosarcoma
Keywords: Humanized Monoclonal Antibody 3F8 (Hu3F8)
Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
15-096
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Children's Hospital Los Angeles
name: M.D. Anderson Cancer Center
name: Y-mAbs Therapeutics
First posted: 2015-07-20
Enrollment: 46
Sex: ALL
Minimum age (years): 13
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: event free survival (EFS)
timeFrame: 12 months
Secondary outcomes:
measure: time to recurrence
timeFrame: 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles (Data Collection Only)
state: California
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Houston
country: United States
facility: MD ANDERSON CANCER CENTER (Data Collection Only)
state: Texas
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Filemon Dela Cruz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.