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Phase II Study of Radiation Therapy and Vismodegib for Advanced Head/Neck Basal Cell Carcinoma | Clinical Trials | Clareo Health

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Phase II Study of Radiation Therapy and Vismodegib for Advanced Head/Neck Basal Cell Carcinoma

A Phase II Study of Radiation Therapy and Vismodegib, for the Treatment of Locally Advanced Basal Cell Carcinoma of the Head and Neck

NCT01835626•Sue Yom

View on ClinicalTrials.gov

Summary

Chemotherapy, radiation therapy, and surgery are standard treatments for basal cell carcinoma at most institutions. The purpose of this study is to determine whether adding vismodegib to radiation (chemoradiotherapy) is safe and tolerable. The purpose of this study is to assess the safety and tolerability of combined radiation therapy and vismodegib. This combination may increase the chances of the tumors being destroyed or unable to spread to other parts of the body in people with locally advanced basal cell carcinoma of the head and neck.

Detailed Description

This is a single arm, multi-center Phase II clinical trial to assess the safety and demonstrate the efficacy of a combined modality approach using radiation therapy after induction and concurrently with systemic administration of vismodegib, which may increase the rates of complete response and sustained local control in patients with locally advanced Basal Cell Carcinoma (BCC)

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with locally advanced BCC of the head and neck, consisting of at least one histologically or cytologically confirmed lesion greater than or equal to 20 mm in longest diameter that is considered to be inoperable or to have a medical contraindication to surgery, in the opinion of a Mohs dermatologic surgeon, head and neck surgeon, or plastic surgeon. Locally advanced disease is considered to include involved lymph nodes of the neck. A patient with regionally involved lymph nodes in the neck is considered eligible. The patient should be considered a candidate for radiotherapy and should not have medical contraindications to receipt of radiation therapy.
•4. Prior vismodegib or other antagonists of the Hh pathway;
•5. Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy, topical therapy such as 5-Fluorouracil or imiquimod, radiation therapy, surgery, or photodynamic therapy.
•* For patients with multiple cutaneous BCCs at baseline that are not designated by the investigator as target lesions, treatment of these non-target BCCs with surgery may be permitted but must be discussed with Data Coordinator prior to any surgical procedure.
•6. Recent (within 4 weeks of Registration), current, or planned participation in another experimental drug study.
•7. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields in such a way that curative intent with radiation cannot be met
•8. Inability or unwillingness to swallow capsules; Patients with any condition that may impair the ability to swallow or absorb oral medications/investigational product including:
•* any lesion, whether induced by tumor, radiation or other conditions, which makes it difficult to swallow capsules or pills;
•* prior surgical procedures affecting absorption including, but not limited to major resection of stomach or small bowel;
•* active peptic ulcer disease;
+10 more criteria

Exclusion Criteria

•Note: All lesions that the investigator proposes to follow as target lesions during the course of the study must have previously been histologically confirmed as BCC.
•Acceptable contraindications to surgery include:
•* BCC that has recurred in the same location after two or more surgical procedures and successful curative resection is deemed unlikely
•* Complete surgical resection is not possible or is deemed excessively morbid (e.g. invasion into cranial nerves or skull base, proximity to brain, spinal canal, or orbit)
•* Anticipated substantial morbidity and/or major deformity from surgery (e.g. removal of a major facial structure, such as nose, ear, eyelid, eye, or jaw; or requirement for upper limb amputation)
•* Medical contraindication to surgery
•* Patient refusal of surgery due to anticipated morbidity
•* Other conditions considered to be contraindicating must be discussed with Data Coordinator before enrolling the patient.
•2. Prior radiation therapy is acceptable but there cannot be major overlap of the previously irradiated tissues with the new radiation treatment volumes anticipated to be delivered for the purposes of this protocol, in such a way that curative intent with radiation cannot be met. Furthermore, the total dose from all radiation delivered and expected to be delivered should not exceed the suggested dose constraints given for normal structures.
•3. Zubrod Performance Status 0-2
+13 more criteria

Locations (2)

University of California, San Francisco

San Francisco, California, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

May 1, 2013

Primary Completion Date

September 10, 2019

Completion Date

September 10, 2019

Last Updated

May 3, 2021

Enrollment

ACTUAL participants

Conditions

Locally Advanced Basal Cell CarcinomaSkin CancerCutaneous Malignancy

Interventions

Vismodegib

DRUG

Radiation therapy

RADIATION

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 3, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase II Study of Radiation Therapy and Vismodegib for Advanced Head/Neck Basal Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

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