Glembatumumab Vedotin in Treating Patients With Recurrent or Refractory Osteosarcoma



Status:Completed
Healthy:No
Age Range:12 - 49
Updated:10/17/2018
Start Date:February 16, 2016
End Date:June 30, 2017

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A Phase 2 Study of GPNMB-Targeted Antibody-Drug Conjugate, CDX-011 (Glembatumumab Vedotin, CR011-vcMMAE; NSC# 763737), in Recurrent or Refractory Osteosarcoma

This phase II trial studies how well glembatumumab vedotin works in treating patients with
osteosarcoma that has come back (recurrent) or does not respond to treatment (refractory).
Monoclonal antibodies, such as glembatumumab vedotin, may find tumor cells and help kill
them.

PRIMARY OBJECTIVES:

I. To estimate whether CDX-011 (glembatumumab vedotin) therapy either increases the disease
control rate at 4 months in patients with recurrent measurable osteosarcoma as compared to an
historical Children's Oncology Group (COG) experience or produces an objective response rate
in patients without previous eribulin (eribulin mesylate) treatment.

SECONDARY OBJECTIVES:

I. To assess the feasibility and toxicity profile of CDX-011 in patients with recurrent
osteosarcoma.

II. To describe the pharmacokinetics of CDX-011 in adolescents and young adults with
recurrent osteosarcoma enrolled at COG sites and COG phase I consortium sites only.

III. To determine if there is a relationship between tumor GPNMB expression by
immunohistochemistry (IHC) and response to CDX-011 therapy.

IV. To estimate, in the cohort of patients previously treated with eribulin, the proportion
who will experience disease progression during the first 4 months of CDX-011 therapy and the
proportion of patients who experience a Response Evaluation Criteria in Solid Tumors
(RECIST)-defined complete or partial response.

OUTLINE:

Patients receive glembatumumab vedotin intravenously (IV) over 90 minutes on day 1. Treatment
repeats every 21 days for up to 18 courses in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Inclusion Criteria:

- Patients must have had histologic verification of osteosarcoma at original diagnosis
or relapse

- Patients must have measurable disease according to RECIST 1.1, and have relapsed or
become refractory to conventional therapy

- Patient must have archival tumor specimen available for submission

- Patients must have a performance status corresponding to Eastern Cooperative Oncology
Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and
Lansky for patients =< 16 years of age

- Patients must have fully recovered from the acute toxic effects of all prior
chemotherapy, immunotherapy, or radiotherapy prior to entering this study

- Myelosuppressive chemotherapy: must not have received within 2 weeks of entry
onto this study (4 weeks if prior nitrosourea)

- Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy
with a biologic agent

- Radiation therapy (RT): >= 2 weeks for local palliative RT (small port); >= 6
months must have elapsed if prior craniospinal RT or if >= 50% radiation of
pelvis; >= 6 weeks must have elapsed if other substantial bone marrow (BM)
radiation

- Monoclonal antibodies: must not have received any monoclonal based therapies
within 4 weeks, and all other immunotherapy (tumor vaccine, cytokine, or growth
factor given to control the cancer) within 2 weeks, prior to study enrollment

- Peripheral absolute neutrophil count (ANC) >= 1000/uL

- Platelet count >= 75,000/uL (transfusion independent)

- Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions)

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:

- Age 1 to < 2 years (male and female: 0.6 mg/dL)

- Age 2 to < 6 years (male and female: 0.8 mg/dL)

- Age 6 to < 10 years (male and female: 1 mg/dL)

- Age 10 to < 13 years (male and female: 1.2 mg/dL)

- Age 13 to < 16 years (male: 1.5 mg/dL and female: 1.4 mg/dL)

- Age >= 16 (male: 1.7 mg/dL and female: 1.4 mg/dL)

- Total bilirubin =< 1.5 x upper limit of normal (ULN) for age

- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or
serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 110
U/L; for the purposes of this study the ULN for SGPT is defined as 45 U/L

- Serum albumin > 2 g/dL

- Shortening fraction of >= 27% by echocardiogram, or

- Ejection fraction of >= 50% by radionuclide angiogram

- All patients and/or their parents or legal guardians must sign a written informed
consent

- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met

Exclusion Criteria:

- Patients with > grade 2 neuropathy according to the Modified ("Balis") Pediatric Scale
of Peripheral Neuropathies will be excluded except in cases in which neuropathy is
secondary to prior surgery

- Patients who have previously received CDX-011 (CR011-vc monomethyl auristatin E
[MMAE]; CDX-011) or other MMAE-containing agents

- Patients who have received other investigational drugs within 2 weeks or 5 half-lives
(whichever is longer) prior to study enrollment

- Patients with a history of allergic reactions attributed to compounds of similar
composition to dolastatin or auristatin; compounds of similar composition include
auristatin PHE as an anti-fungal agent, auristatin PE (TZT-1027, Soblidotin,
NSC-654663) as an anti-tumor agent and symplostatin 1 as an anti-tumor agent

- Patients with known central nervous system metastasis are not eligible

- Patients who have had major surgery within 2 weeks prior to enrollment are not
eligible; procedures such as placement of a central vascular catheter, or limited
tumor biopsy, are not considered major surgery

- Female patients who are pregnant are ineligible

- Lactating females are not eligible unless they have agreed not to breastfeed their
infants

- Female patients of childbearing potential are not eligible unless a negative pregnancy
test result has been obtained

- Sexually active patients of reproductive potential are not eligible unless they have
agreed to use an effective contraceptive method for the duration of their study
participation and for 2 months after the end of study treatment
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Las Vegas, Nevada 89169
Principal Investigator: Alan K. Ikeda
Phone: 702-384-0013
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Las Vegas, NV
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Las Vegas, Nevada 89182
Principal Investigator: Alan K. Ikeda
Phone: 702-384-0013
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Las Vegas, NV
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Las Vegas, Nevada 89128
Principal Investigator: Alan K. Ikeda
Phone: 702-384-0013
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Las Vegas, NV
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6190 South Fort Apache Road
Las Vegas, Nevada 89148
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Las Vegas, NV
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Sara Chaffee
Phone: 800-639-6918
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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Lexington, Kentucky
Principal Investigator: Lars M. Wagner
Phone: 859-257-3379
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Lexington, KY
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Principal Investigator: David L. Becton
Phone: 501-364-7373
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Little Rock, AR
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Principal Investigator: Albert Kheradpour
Phone: 909-558-3375
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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Loma Linda, CA
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4733 Sunset Blvd
Los Angeles, California 90027
(800) 954-8000
Principal Investigator: Robert M. Cooper
Phone: 626-564-3455
Kaiser Permanente Los Angeles Medical Center We've been there for you in the past, providing...
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Los Angeles, CA
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Los Angeles, California 90095
Principal Investigator: Noah C. Federman
Phone: 310-825-6708
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Los Angeles, CA
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