NCT02068157 · REGISTRY CONDITION SEARCH

Interstitial Photodynamic Therapy in Treating Patients With Recurrent Head and Neck Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2017-10-11

This phase II trial studies the effects of interstitial photodynamic therapy in patients with head and neck cancer that has come back. Interstitial photodynamic therapy uses a combination of laser light and a light-sensitive drug called porfimer sodium to destroy tumors. During treatment a laser light is used to activate the drug. Interstitial photodynamic therapy may be an effective treatment for head and neck cancer.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1

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outcome · POSTED

Serum Alkaline DNase (SADA) Activity

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 * Histologically confirmed recurrent squamous cell carcinoma of the oral cavity, pharynx, (oropharynx, larynx) and neck * Tumor accessible for unrestricted illumination for interstitial photodynamic therapy (PDT) (accessibility as determined by the physician) * Patients on chemotherapy \&/or targeted agents for palliation * Life expectancy of at least 6 months in the judgment of the physician * Subjects of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for 6 months after the last treatment; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Subject or legal representative must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Radiotherapy within the last 2 months in the area to be treated * Patients with known brain metastases should be excluded from this clinical trial * Tumor invading a major blood vessel (such as the carotid artery) * Tumor is not clearly shown on a computed tomography (CT) scan * Location and extension of the tumor precludes an effective I-PDT * Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds * While blood cell (WBC) \< 2.0 x 10\^9/L * Total serum bilirubin \> 2.0 mg/dl * Serum creatinine \> 2 mg/dl * Alkaline phosphatase (hepatic) \> 3 times the upper normal limit * Serum glutamic oxaloacetic transaminase (SGOT) \> 3 times the upper limit of normal * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, acute exacerbation of congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or nursing female subjects * Unwilling or unable to follow protocol requirements and the light exposure precautions * Any condition which in the Investigators' opinion deems the subject an unsuitable candidate to receive study drug and therapy
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
intervention Names
Other: Laboratory Biomarker Analysis
Drug: Photodynamic Therapy
Drug: Porfimer Sodium
label
Treatment (porfimer sodium, image-guided I-PDT)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (porfimer sodium, image-guided I-PDT)
description
Correlative studies
name
Laboratory Biomarker Analysis
type
OTHER
arm Group Labels
Treatment (porfimer sodium, image-guided I-PDT)
description
Undergo image-guided I-PDT
name
Photodynamic Therapy
other Names
PDT
Photoradiation Therapy
type
DRUG
arm Group Labels
Treatment (porfimer sodium, image-guided I-PDT)
description
Given IV
name
Porfimer Sodium
other Names
CL-184116
DHE
Dihematoporphyrin Ester
Dihematoporphyrin Ether
Photofrin II
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 3
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Tumor response rate according to Response Evaluation Criteria in Solid Tumors 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
measure
Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1
time Frame
Up to 12 months

secondary Outcomes

description
SADA activity will be correlated with tumor response according to the guidelines of the revised Response Criteria in Solid Tumors 1.1.
measure
Serum Alkaline DNase (SADA) Activity
time Frame
Up to 12 months

Full study description

brief Summary: This phase II trial studies the effects of interstitial photodynamic therapy in patients with head and neck cancer that has come back. Interstitial photodynamic therapy uses a combination of laser light and a light-sensitive drug called porfimer sodium to destroy tumors. During treatment a laser light is used to activate the drug. Interstitial photodynamic therapy may be an effective treatment for head and neck cancer.
detailed Description: PRIMARY OBJECTIVES: I. Demonstrate that our image-guided interstitial photodynamic therapy (I-PDT) dosimetry system can be used to tailor this therapy to individual patients. OUTLINE: Patients receive porfimer sodium intravenously (IV) over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2. After completion of study, patients are followed up at 1 month, 2 months, 4 months, and then every 2 months for up to 12 months.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice