Study Evaluating a Stereotactic Boost/Treatment for Recurrent or Metastatic Cancer of the Head and Neck

NCT02474368 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: 15-183
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This research study seeks to gain new knowledge about the addition of a carefully targeted "boost" dose of radiation as a possible treatment for recurrent or metastatic head or neck cancer. The name of the study intervention involved in this study is stereotactic body radiotherapy, which is a way of delivering radiation in a more precisely targeted way and with a higher dose than conventional radiotherapy.

Conditions

Recurrent Head and Neck Carcinoma; Head and Neck Cancer Metastatic; Head or Neck Cancer

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose of stereotactic body radiotherapy treatment (SBRT) when given as a boost in combination with cisplatin and intensity modulated radiation therapy (IMRT)

  Cohort 1: patients who have received prior radiation in the head and neck and currently have gross unresectable disease;

  1 Year

• Maximum tolerated dose of stereotactic body radiotherapy treatment (SBRT) when given for disease metastatic to the head and neck

  Cohort 2: Patients with metastatic disease with targetable lesions within the head and neck.

  1 year

Secondary Outcomes (7)

• Number of Participants with Adverse Events

  1 Year

• Local Control Rate

  1 Year

• Regional Control Rate

  1 Year

• Progression Free Survival using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  1 year

• Level of circulating activated T cells as an immune correlate of stereotactic treatment

  1 Year

Study Arms (2)

Cohort 1

EXPERIMENTAL

* Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. * Cohort 1 (patients who have received prior radiation in the head and neck with gross unresectable disease) * Intensity Modulated Radiation Therapy (IMRT) : daily for 6 weeks * Cisplatin will be administered intravenously on predetermined days * Stereotactic Body Radiotherapy (SBRT)

Radiation: Intensity Modulated Radiation Therapy (IMRT); Drug: Cisplatin; Radiation: Stereotactic Body Radiotherapy (SBRT)

Cohort 2

EXPERIMENTAL

* Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. * Cohort 2 (patients with metastatic solid tumors of any histology who have targetable lesions within the head and neck) -- Stereotactic Body Radiotherapy (SBRT)

Radiation: Stereotactic Body Radiotherapy (SBRT)

Interventions

Intensity Modulated Radiation Therapy (IMRT) RADIATION

Cohort 1

Cisplatin DRUG

Also known as: Platinol-AQ, Platinol

Cohort 1

Stereotactic Body Radiotherapy (SBRT) RADIATION

Cohort 1; Cohort 2

Eligibility Criteria

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

You may qualify if:

• Participants must meet the following criteria on screening examination to be eligible to participate in the study:
• All cohorts:
• Participants must have a pathologic cancer diagnosis.
• No other active malignancy within the past 2 years, except for non-melanoma skin cancers or carcinoma in situ of the cervix.
• Only patients 18 years and older are eligible. There is no upper age limit but the patients must be able to medically tolerate the regimen. Adverse event data are currently unavailable on the use of SBRT for participants \< 18 years of age, and thus children are excluded from this study.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (see Appendix A).
• Ability to understand and the willingness to sign a written informed consent document
• Cohort 1 (reirradiation in patients with head and neck cancers with gross unresectable disease):
• History of radiation to the head and neck area (defined as above the clavicles) greater than 6 months previous
• Pathologically proven recurrent disease or a second primary (squamous cell carcinoma of the head and neck, nasopharyngeal cancer, salivary gland cancer, or thyroid cancer) within the head and neck region, deemed to be unresectable or resected with gross residual disease remaining (determined by either operative/pathology report or post-surgical imaging)
• Participants must have normal organ and marrow function as defined below:
• Leukocytes ≥ 3,000/mcL (microliter)
• Absolute neutrophil count \> ↓1,500/mcL (microliter)
• Platelets ≥100,000/mcL (microliter)
• Total bilirubin within normal institutional limits

You may not qualify if:

• Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
• SBRT target size \> 6 cm in maximum diameter (or greater than 100 cc in volume).
• Participants may not be receiving any other study agents.
• Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because radiotherapy has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with SBRT, breastfeeding should be discontinued if the mother is treated with SBRT.
• Individuals with a history of a different malignancy are ineligible except for the following circumstances: if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; or if diagnosed and treated within the past 2 years for cervical cancer in situ or basal cell or squamous cell carcinoma of the skin.
• HIV-positive individuals on combination antiretroviral therapy are ineligible because of the potential for interaction between conventional radiotherapy, SBRT and antiretroviral medications. In addition, these individuals are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
• Patients who are planned to receive the following medications:
• Granulocyte stimulating factor (G-CSF)
• Bevacizumab
• Cyclosporine
• Anti-tumor necrosis factor agents
• Amifostine

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Radiotherapy, Intensity-Modulated; Cisplatin; Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jonathan Schoenfeld, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 13, 2015
• First Posted: June 17, 2015
• Study Start: November 1, 2015
• Primary Completion: January 1, 2021
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)