Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
15-096
- NCT ID:
NCT02502786
Conditions
Interventions
Drug | Synonyms | Arms |
---|
humanized anti-GD2 antibody | hu3F8 | humanized anti-GD2 antibody, hu3F8, when combined with GM-CSF |
GM-CSF | | humanized anti-GD2 antibody, hu3F8, when combined with GM-CSF |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
humanized anti-GD2 antibody, hu3F8, when combined with GM-CSF | Experimental | 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. | - humanized anti-GD2 antibody
- GM-CSF
|
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.
Maximum Eligible Age: | 40 Years |
Minimum Eligible Age: | 13 Months |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | event free survival (EFS) |
Time Frame: | 12 months |
Safety Issue: | |
Description: | EFS is defined as the time from surgery to relapse or death from any cause, recurrence of tumor or second malignancy. |
Secondary Outcome Measures
Measure: | time to recurrence |
Time Frame: | 12 months |
Safety Issue: | |
Description: | 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. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Memorial Sloan Kettering Cancer Center |
Trial Keywords
- Humanized Monoclonal Antibody 3F8 (Hu3F8)
- Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
- 15-096
Last Updated
June 4, 2021