Entolimod in Treating Patients With Stage III-IV Squamous Cell Head and Neck Cancer Receiving Cisplatin and Radiation Therapy
NCT ID: NCT01728480
Last Updated: 2013-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2014-01-31
Brief Summary
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Detailed Description
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I. To define the Phase II dose of CBLB502 (entolimod) when given as weekly injections during irradiation with cisplatin, for patients with poor prognosis advanced squamous cell carcinomas of the head and neck receiving chemoradiotherapy.
SECONDARY OBJECTIVES:
I. To describe the adverse event (AE) profile and the dose limiting toxicities of CBLB502 when administered weekly in combination with cisplatin and radiation therapy.
II. To determine the maximally tolerated dose (if observed) of CBLB502 in combination with cisplatin and radiation therapy.
III. To describe the pharmacokinetics (PK) of CBLB502 when administered in combination with cisplatin.
IV. To describe the pharmacodynamics (PD) of CBLC502 by examining plasma levels of various cytokines, including filgrastim (granulocyte-colony stimulating factor \[G-CSF\]), interleukin (IL)-6, IL-8, IL-10, and tumor necrosis factor-alpha (TNF-α).
V. To describe any clinical activity of CBLB502 in the form of mitigation of mucositis.
VI. To describe the response rate to chemoradiotherapy in combination with CBLB502.
OUTLINE: This is a dose-escalation study of entolimod.
Patients undergo intensity-modulated radiation therapy (IMRT) 5 times per week for 7 weeks, receive cisplatin intravenously (IV) once weekly for 7 weeks, and entolimod subcutaneously (SC) on days 1, 8, 15, 22, 29, 36, and 43.
After completion of study treatment, patients are followed up for 3 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (entolimod, IMRT, cisplatin)
Patients undergo IMRT 5 times per week for 7 weeks, receive cisplatin IV once weekly for 7 weeks, and entolimod SC on days 1, 8, 15, 22, 29, 36, and 43.
entolimod
Given SC
intensity-modulated radiation therapy
Undergo IMRT
cisplatin
Given IV
pharmacological study
Correlative studies
laboratory biomarker analysis
Correlative studies
Interventions
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entolimod
Given SC
intensity-modulated radiation therapy
Undergo IMRT
cisplatin
Given IV
pharmacological study
Correlative studies
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
* Induction chemotherapy (up to 3 cycles of cetuximab/taxanes/platinum based regimens) is allowed
* Patients or their legal representatives must be able to comprehend and provide written informed consent
* Absolute neutrophil count =\> 1,500/uL
* Platelets \>= 100,000/uL
* Total bilirubin within normal institutional limits
* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit normal (ULN)
* Calculated creatinine clearance \>= 60 mL/min (Cockcroft-Gault equation)
* 12-Lead Electrocardiogram (ECG) with normal tracing or non-clinically significant changes that do not require medical intervention
* Bazett's corrected QT (QTcB) interval \< 470 msec at any timepoint prior to receiving the first dose of study drug (mean of replicate values, correction per institutional standard) and no history of Torsades des Pointes or other symptomatic QTcB abnormality
* Absence of orthostatic hypotension
* Patients must be sufficiently recovered from induction chemotherapy to allow initiation therapy
Exclusion Criteria
* Male and female patients of child-bearing potential who do not agree to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after last investigational drug dose received
* Contraindication to full course chemoradiotherapy with cisplatin
* Previous treatment with a toll-like receptor 5 (TLR5) agonist
* Presence of neutralizing antibodies to CBLB502
* Patients with an active infection or with a fever \>= 38.5ºC within 3 days of the first scheduled day of dosing; patients who are registered but develop a fever of \>= 38.5ºC may remain in the study if the fever abates prior to the expiration of the screening procedures; if the screening procedures have expired, the patient may be re-screened once afebrile
* Patients with a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory or inflammatory illness that could preclude their participation in the study, pose an undue medical hazard or interfere with the interpretation of the study results, including, but not limited to, patients with congestive heart failure (New York Heart Association \[NYHA\] class 3 or class 4); unstable angina; cardiac arrhythmia; recent (within the preceding 6 months) myocardial infarction or stroke; hypertension requiring \> 2 medications for adequate control; diabetes mellitus with \> 2 episodes of ketoacidosis in the preceding 12 months; chronic obstructive pulmonary disease (COPD) requiring \> 2 hospitalizations in the preceding 12 months
* Patients with a history of, or known autoimmune disease, but not limited to systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, ankylosing spondylitis, sarcoidosis, vasculitis, Wegener's granulomatosis, Hashimoto's thyroiditis, ulcerative colitis, Crohn's disease, Goodpasture's disease, multiple sclerosis, etc.
* Patients with any other medical, psychiatric or social condition that would preclude their participation in the study, pose an undue medical hazard, interfere with the conduct of the study or interfere with interpretation of the study results
* Patients taking sucralfate, palifermin or amifostine
* Patients receiving hematopoietic growth factors
* Patients currently taking, or who have taken within 30 days of the initiation of protocol therapy, any immunomodulatory therapy, including pharmacologic doses of glucocorticoids (topical and inhalation glucocorticoids are permitted), azathioprine, methotrexate, interferon-alpha, interferon-beta, interluekin-2, etanercept, infliximab, tacrolimus, cyclosporine, mycophenolic acid, etc
* Patients with a history of hypersensitivity reactions to any of the components of CBLB502 or cisplatin
* Women who are pregnant or lactating or who are planning on becoming pregnant during the study or for 90 days after completion of the study
* Patients who have received an investigational therapy within 4 weeks of signing the informed consent for the current study
* Patients with a history of, patients who were treated for, or patients who are suspected of having, hepatitis B, and hepatitis C or human immunodeficiency virus (HIV); patients suspected of having any of these conditions should undergo appropriate evaluations prior to being enrolled in the study
* Surgery with significant defect or flap in the oral cavity
* Poor dentition or ill-fitting dental appliances (can be enrolled if this can be corrected by a dentist prior to start of radiation therapy)
* Presence of other medical conditions causing mucositis (e.g., rheumatologic, gastroesophageal reflux, etc.)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Cleveland BioLabs, Inc.
INDUSTRY
Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Anurag Singh
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Countries
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Other Identifiers
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NCI-2012-02140
Identifier Type: REGISTRY
Identifier Source: secondary_id
I 209611
Identifier Type: -
Identifier Source: org_study_id