Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Cemiplimab

Interferons

Interferon-alpha

Peginterferon alfa-2a

Interferon alpha-2

Antiviral Agents

Antineoplastic Agents, Immunological

Cemiplimab administered at 350 mg intravenous (IV) every three weeks for up to 2 years. PEG-IFN-alpha administered subcutaneously weekly at doses of 45 mcg to 135 mcg for up to 1 year. Exact dosing will depend on when the participant is enrolled in the study and the number of serious adverse effects that have been encountered by previous participants, if any.

350 mg via IV infusion over 30 minutes every 3 weeks for up to two years

Cemiplimab-Rwlc

Self-administered by the participant via subcutaneous injection in the abdomen or thigh weekly for up to one year. Participants will receive one of three doses:

Dose level 0: 45 mcg

Dose level 1: 90 mcg

Dose level 2: 135 mcg

Dose level 0 is considered the starting dose and sequential cohorts of three participants will be treated with escalated doses until the maximum tolerated dose is established.

PEG-IFN alfa-2a

Guilherme Rabinowits, M.D.

The primary purpose of this research study is to test the safety and possible harms of cemiplimab/peg-interferon-alpha, when it is given to participants at different dose levels. The researchers want to find out what effects (good and bad) cemiplimab/Peg-Interferon has on participants with advanced cutaneous squamous cell carcinoma (aCSCC) so that they can find the best dose to treat aCSCC and reduce side effects as much as possible.

Cemiplimab/Peg-Interferon-α in Advanced CSCC

Cemiplimab/PEG-Interferon-α Combination for Advanced Cutaneous Squamous Cell Carcinoma (aCSCC)

DLT rate by dose level, frequency distribution of treated participants with AE using the worst common terminology criteria grade. Participants will be counted only (1) once at the preferred term level, (2) once at the system organ class level, and (3) once in the "total participant" row at their worst common terminology criteria grade, regardless of system organ class or preferred term.

The DLT window of observation will be during treatment cycle 1 only (i.e., during the first 21-day cycle; adverse events (AEs) meeting the definition of a DLT but occurring after this period will not be considered DLTs). The occurrence of certain toxicities during treatment cycle 1 will be considered a DLT, if assessed by the investigator to be possibly related or related to PEG-IFN-α and/or cemiplimab.

RR is defined as the proportion of participants whose best overall response is complete (CR) or partial (PR).

DOR is defined as the amount of time from the initiation of study therapy to the first documented disease progression or death due to any cause, whichever occurs first in participants who had achieved CR or PR.

PFS is defined as the time from the initiation of study therapy to the first documented disease progression or death due to any cause, whichever occurs first

OS is defined as the time from the initiation of study therapy to death due to any cause or date of last follow-up, whichever occurs first.

Regeneron Pharmaceuticals

Baptist Health South Florida

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Docetaxel

Fluorouracil

Cisplatin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

5-Fluorouracil

Marshall Posner, MD

The purpose of this study is to determine the appropriate dose, that dose which is found to give maximum effect with limited toxicity, of cisplatin in combination with docetaxel and 5-fluorouracil and then to further define the safety and effectiveness of this combination of medications.

* Treatment begins with a one hour infusion of docetaxel followed by a 1/2 hour infusion of cisplatin. 5-fluorouracil will be administered through continuous IV infusion through a portable pump for four days at home. A cycle is twenty-one days long ( 4 days of chemotherapy and 17 days of recovery).
* During each cycle blood tests will be performed weekly. A physical exam will be performed and the impact of the chemotherapy will be assessed at the end of each cycle.
* If after 2 cycles the patients cancer has not responded sufficiently they will be removed from the study.
* If significant reduction in the size of the tumor is observed after cycle 2, a third and final cycle will be performed. Followed by radiation therapy twice daily for approximately 6-7 weeks.

Study of Docetaxel in Combination With Cisplatin and 5-Fluorouracil in Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Phase I/II Pilot Study of Induction Chemotherapy With Docetaxel in Combination With Cisplatin and 5-Fluorouracil (5-FU) in Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Brigham and Women's Hospital

Sanofi

Dana-Farber Cancer Institute

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Laryngeal Diseases

Laryngeal Cancer

Increased dose of radiation therapy for locally advanced squamous cell carcinoma of the larynx or hypopharynx. Patients will also receive standard-of-care chemotherapy with the treatment regimen to be determined by the treating physicians.

Radiation Therapy

Standard-of-care chemotherapy with treatment regimen to be determined by the treating physician

Chemotherapy

Robert J Amdur, MD

This is a phase 2 single arm study of a novel schedule of hyperfractionated radiotherapy (RT) in combination with our standard chemotherapy program for patients with stage 3-4 squamous cell carcinoma of the larynx. The primary hypothesis of our study is that the study program will improve Laryngectomy-Free Survival compared to historical controls. The study is limited to patients who would be receiving primary RT-C as standard therapy off-study.

The novel radiotherapy schedule that is the subject of this study is only slightly different from the program that has been used in the cooperative group trial RTOG 9003. The radiation therapy dose schedule in our study twice-daily alternating fractions over 30 treatment days. The Biologically Effective Dose (BED) of this schedule is about 11% higher than our standard schedule twice-a-day. During radiotherapy, patients will receive chemotherapy with our standard program of weekly.

Radiotherapy Dose Escalation in Locally Advanced Squamous Cell Carcinoma of the Larynx or Hypopharynx

Patients will receive an increased dose of radiation therapy

The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients Likert scales 1-4,(1 = All, 2 = Little, 3 = a Bit, 4 = Very much)

Voice Handicap Index (VHI) a 30-item questionnaire. Likert scale 0- 4, 0 = never and 4 Always) A change between two administrations of 18 points represents a significant shift in psychosocial function.

The MD Anderson Symptom Inventory (MDASI) is a multi-symptom patient-reported outcome (PRO) measure for clinical and research use. Use the MDASI to assess the severity of symptoms experienced by patients with cancer and the interference with daily living caused by these symptoms.MD Anderson Dysphagia Index (MDADI)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cemiplimab/Peg-Interferon-α in Advanced CSCC	NCT05729139	Cutaneous Squam... Squamous Cell C... Advanced Squamo...	Cemiplimab-Rwlc PEG-IFN alfa-2a	18 Years -	Baptist Health South Florida
Study of Docetaxel in Combination With Cisplatin and 5-Fluorouracil in Locally Advanced Squamous Cell Carcinoma of the Head and Neck	NCT00139269	Advanced Squamo... Squamous Cell C... SSCHN	Docetaxel Cisplatin 5-Fluorouracil	18 Years -	Dana-Farber Cancer Institute
Radiotherapy Dose Escalation in Locally Advanced Squamous Cell Carcinoma of the Larynx or Hypopharynx	NCT03388931	Advanced Squamo...	Radiation Thera... Chemotherapy	18 Years -	University of Florida

Spots Global Cancer Trial Database for advanced squamous cell carcinoma