Mucositis Clinical Trial
Official title:
A Phase I Study of CBLB502 in the Treatment of Patients With Poor Prognosis Advanced Squamous Cell Carcinomas of the Head and Neck Receiving Chemoradiotherapy
This phase I trial studies the side effects and best dose of entolimod in treating patients with stage III-IV or recurrent head and neck cancer. Biological therapies, such as entolimod, may stimulate the immune system in different ways and stop tumor cells from growing. Entolimod may also prevent side effects caused by chemotherapy with cisplatin and radiation therapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving entolimod together with cisplatin and radiation therapy may kill more tumor cells
PRIMARY OBJECTIVES:
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.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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