Stereotactic Body Radiotherapy and Concurrent Cisplatin for Re-Irradiation of Unresectable, Recurrent Squamous Cell Carcinomas of Head and Neck

NCT02158234 | Completed Phase 1 FDA Drug

• 1 other identifier: MCC-17799
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study involves another course of radiation (called re-irradiation) to the participant's tumor. The type of radiation is called stereotactic body radiation therapy (SBRT). The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given along with the chemotherapy drug, cisplatin. The researchers want to see which dose of radiation will work best in controlling the growth of head/neck cancer. The usual treatment for head/neck cancer that has grown is surgery and/or more radiation with various chemotherapy drugs.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Keywords

squamous cell carcinoma; head and neck cancer; paranasal sinuses; nasal cavity; nasopharynx; oropharynx; oral cavity; larynx; hypopharynx; salivary glands; cervical lymph nodes

Outcome Measures

Primary Outcomes (1)

• Maximal Tolerated Dose (MTD) of Stereoactive Body Radiation Therapy (SBRT)

  The traditional 3+3 dose escalation method will be utilized for this phase I study, with up to 3 sequential cohorts. The maximal tolerated dose (MTD) of Stereotactic Body Radiation Therapy (SBRT) radiation dose associated with a ≤ 33% probability of dose-limiting toxicity (DLT). DLT is defined as any grade 4 or greater toxicity, per The Common Terminology Criteria for Adverse Events v4 (CTCAE v4) that occurs within 3 months from the start of SBRT.

  Up to 24 months

Secondary Outcomes (2)

• Local Control Rate

  Up to 24 months

• Overall Survival (OS)

  Up to 24 months

Study Arms (1)

Dose Escalation: SBRT and Cisplatin

EXPERIMENTAL

Stereotactic Body Radiation Therapy (SBRT) and Cisplatin. Starting Dose: 6 Gy/ Fraction 5/ Total 30 Gy/ Cisplatin 15 mg/m\^2

Drug: Cisplatin; Radiation: Stereotactic Body Radiation Therapy (SBRT)

Interventions

Cisplatin DRUG

Cisplatin 15 mg/m\^2 prior to each fraction

Also known as: chemotherapy, cis-diamminedichloroplatinum, CDDP, alkylating agent, cisplatinum

Dose Escalation: SBRT and Cisplatin

Stereotactic Body Radiation Therapy (SBRT) RADIATION

All participants will be treated every other day (excluding Saturday/Sunday). Starting Dose: 6 Gy/ Fraction 5/ Total 30 Gy.

Also known as: stereotactic ablative radiotherapy, radiation therapy

Dose Escalation: SBRT and Cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recurrence of previously pathologically proven squamous cell carcinoma of the head and neck, including original primary sites in the paranasal sinuses, nasal cavity, nasopharynx, oropharynx, oral cavity, larynx, hypopharynx, salivary glands, and/or involvement of cervical lymph nodes
• Prior radiotherapy to doses ≥ 45 Gy to the area of recurrence, ≥ 6 months prior to enrollment
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2
• Life expectancy \> 6 months
• Medically unfit for surgery or deemed surgically unresectable by head and neck (H\&N) surgeon within 60 days prior to enrollment, or patient refusal of surgery
• Normal organ and marrow function
• No prior evidence of Grade 3 or greater toxicity or neuropathy
• Medically fit to receive cisplatin

You may not qualify if:

• Positive urine pregnancy test and/or breastfeeding. Women of childbearing potential or sexually active males must be willing to use effective contraception throughout their participation in the treatment phase of the study.
• Evidence of distant metastases
• Tumor size \> 7 cm in one direction
• Tumor within 1 cm of the spinal cord
• Cardiac history: class III or greater congestive heart failure (CHF) or myocardial infarction (MI) within last 6 months
• Medical condition or social situation that at the discretion of the principal investigator (PI) would preclude them from completion of the trial

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Laryngeal Diseases

Interventions

Cisplatin; Drug Therapy; Alkylating Agents; Radiosurgery; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Squamous Cell; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Noxae; Toxic Actions; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jimmy Caudell, M.D., Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: June 6, 2014
• Study Start: July 16, 2014
• Primary Completion: August 24, 2021
• Study Completion: August 24, 2021
• Last Updated: January 19, 2023

Record last verified: 2022-08

Locations

US (1)