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Interstitial Photodynamic Therapy for Recurrent Squamous Cell Carcinoma of the Oropharynx and Oral Cavity


N/A
18 Years
N/A
Not Enrolling
Both
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Verrucous Carcinoma of the Oral Cavity, Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage I Squamous Cell Carcinoma of the Oropharynx, Stage I Verrucous Carcinoma of the Oral Cavity, Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage II Squamous Cell Carcinoma of the Oropharynx, Stage II Verrucous Carcinoma of the Oral Cavity, Tongue Cancer

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Trial Information

Interstitial Photodynamic Therapy for Recurrent Squamous Cell Carcinoma of the Oropharynx and Oral Cavity


PRIMARY OBJECTIVES:

I. To assess the toxicity of dose regimen using the Cancer Therapy Evaluation Program (CTEP)
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE
version 4.0).

SECONDARY OBJECTIVES:

I. Quantify the relationship between the measured intra-tumor light dose and the
pathological tumor response.

TERTIARY OBJECTIVES:

I. Simulate light dose distribution within the treated tumor. II. Immune markers. III.
Circulating endothelial cells.

OUTLINE:

Patients receive temoporfin intravenously (IV) over at least 6 minutes on day 1 and undergo
interstitial photodynamic therapy on day 3. Within 4-6 weeks, patients undergo surgical
resection.

After completion of study treatment, patients are followed up at 30 days.


Inclusion Criteria:



- Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

- Histologically confirmed recurrent squamous cell carcinoma of the oropharynx or oral
cavity that are amenable to surgery

- Tumor accessible for unrestricted illumination for interstitial photodynamic therapy
(PDT) (accessibility as determined by the physician)

- Life expectancy of at least 6 months in the judgment of the physician

- Blood urea nitrogen (BUN) =< upper limit of normal (ULN)

- White blood count > 3,000 per microliter or

- Absolute neutrophil count (ANC) > 1500 per microliter

- Serum calcium within normal limits; note: serum calcium will be corrected for low
albumin, if necessary

- 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 the duration of study participation; 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:

- Subjects who have had radiotherapy within the last 3 months

- Subjects with known brain metastases should be excluded from this clinical trial

- Tumor invading a major blood vessel (such as the carotid artery)

- Tumor invading the skull base

- Subjects with ophthalmic disease

- Tumor is not clearly shown on an imaging scan/location and extension of tumor that
precludes effective PDT, in the judgment of the primary investigator (PI)

- Location and extension of the tumor precludes an effective interstitial photodynamic
therapy (iPDT)

- Patients with known hypersensitivity to porphyrins or with porphyria

- Has distant metastasis that decreases life expectancy to less than 6 months

- 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 or nursing female subjects

- Unwilling or unable to follow protocol requirements and the light exposure
precautions

- Any condition which in the investigator's opinion deems the subject an unsuitable
candidate to receive study drug

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency of adverse events, graded according to NCI CTCAE version 4.0

Outcome Description:

The frequency of toxicities will be tabulated by grade.

Outcome Time Frame:

Up to 30 days after surgical resection

Safety Issue:

Yes

Principal Investigator

Nestor Rigual

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

I 217512

NCT ID:

NCT01718223

Start Date:

May 2013

Completion Date:

Related Keywords:

  • Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Recurrent Squamous Cell Carcinoma of the Oropharynx
  • Recurrent Verrucous Carcinoma of the Oral Cavity
  • Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage I Squamous Cell Carcinoma of the Oropharynx
  • Stage I Verrucous Carcinoma of the Oral Cavity
  • Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage II Squamous Cell Carcinoma of the Oropharynx
  • Stage II Verrucous Carcinoma of the Oral Cavity
  • Tongue Cancer
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Tongue Neoplasms
  • Oropharyngeal Neoplasms
  • Carcinoma, Verrucous

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263