Photodynamic Therapy With HPPH in Treating Patients With Squamous Cell Carcinoma of the Oral Cavity

April 19, 2016 updated by: Roswell Park Cancer Institute

A Randomized Multicenter Phase II Study Using HPPH With PDT Versus Standard of Care Surgery for Patients With T1/T2 Squamous Cell Carcinoma of the Oral Cavity

This randomized phase II trial studies how well photodynamic therapy with HPPH works in treating patients with squamous cell carcinoma of the oral cavity. Photodynamic therapy uses HPPH that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. This may be effective against squamous cell carcinoma of the oral cavity.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To test the non-inferiority of photodynamic therapy (PDT) to standard of care surgery.

SECONDARY OBJECTIVES:

I. To determine improvement in quality of life (QoL) using the University of Washington Quality of life questionnaire version 4.

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

III. To explore progression-free survival in this patient population treated with HPPH mediated PDT.

TERTIARY OBJECTIVES:

I. Immune markers (T cells). II. To investigate the correlation of the tri-modal optical spectroscopy with tumor response to PDT.

OUTLINE: Patients are randomized to 1 of 2 treatments arms.

ARM I: Patients undergo standard of care surgery on day 1.

ARM II: Patients receive HPPH intravenously (IV) over 1 hour on day 0. Approximately 24 hours later, patients undergo photodynamic therapy on day 1.

After completion of study treatment, patients are followed up 3-4 months for 1 year, 3-6 months for 1 year, 4-8 months for 1 year, and once a year for 2 years.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
  • Patients with Tl/T2 squamous cell carcinoma of the oral cavity with or without extension to the oropharynx
  • Histologically confirmed squamous cell carcinoma of the target tumor(s)
  • Tumor thickness is 4 mm or less (in the judgment of the physician)
  • Computed tomography (CT) of the neck to confirm staging
  • Tumor accessible for unrestricted illumination for photodynamic therapy (PDT) (accessibility as determined by the physician)
  • Life expectancy of at least 12 months in the judgment of the physician
  • Patients 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
  • Patient 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:

  • Patients who have had chemotherapy or radiotherapy or targeted agents within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Patients with known brain metastases should be excluded from this clinical trial
  • Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds
  • White blood cells (WBC) < 4,000
  • Total serum bilirubin > 2 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 normal limit
  • 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
  • Nodal disease as detected by clinical exam or CT
  • Pregnant or nursing female patients
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug
  • Received an investigational agent within 30 days prior to enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Arm I (standard of care surgery)
Patients undergo standard of care surgery on day 1.
Procedure: therapeutic conventional surgery
Undergo standard of care surgery
EXPERIMENTAL: Arm II (HPPH, photodynamic therapy)
Patients receive HPPH IV over 1 hour on day 0. Approximately 24 hours later, patients undergo photodynamic therapy on day 1.
Drug: HPPH
Undergo photodynamic therapy with HPPH
Other Names:
  • Photochlor
Device: Light Infusion Therapy™
Undergo photodynamic therapy with HPPH
Other Names:
  • PDT
  • therapy, photodynamic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective tumor response assessed according to Response Evaluation Criteria in Solid Tumors version 1.1
Time Frame: 3 months after treatment
Objective tumor response will be tabulated overall. Tumor response will be determined by comparing photographs of the treated site (with reference ruler) before and after PDT. Efficacy (e.g., tumor response) will be estimated using simple relative frequencies. The corresponding 95% confidence intervals for the estimated probabilities will be computed using the method proposed in Clopper and Pearson.
3 months after treatment
Changes in quality of life evaluated by the University of Washington Quality of Life Questionnaire version 4
Time Frame: Baseline to up to 5 years
In the analysis of QoL simple data analyses will initially take place including individual patient level profile plots and overall mean plots used to examining the mean structure. Formal statistical examination of longitudinal patterns will be done through the use of a mixed model. All tests will be two-sided and tested at a 0.05 nominal significance level. Standard diagnostic plots will be used to assess model fit and transformations of variables may be considered in order to meet statistical assumptions.
Baseline to up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of toxicity graded according to NCI CTCAE version 4.0
Time Frame: Up to 6 weeks after treatment
The frequency of toxicities will be tabulated by grade across all cycles. The safety of the interventions will be assessed through the evaluation of grade 3 or higher toxicities deemed possibly related to treatment. Toxicity rates will be estimated using simple relative frequencies. The corresponding 95% confidence intervals for the estimated probabilities will be computed using the method proposed in Clopper and Pearson.
Up to 6 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Hassan Arshad, Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (ANTICIPATED)

January 1, 2017

Study Registration Dates

First Submitted

April 17, 2014

First Submitted That Met QC Criteria

April 21, 2014

First Posted (ESTIMATE)

April 22, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

April 21, 2016

Last Update Submitted That Met QC Criteria

April 19, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I 246513 (OTHER: Roswell Park Cancer Institute)
  • P30CA016056 (U.S. NIH Grant/Contract)
  • P01CA055791 (U.S. NIH Grant/Contract)
  • NCI-2014-00756 (REGISTRY: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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