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Photodynamic Therapy With HPPH Compared to Standard of Care Surgery in Treating Patients With Oral Cavity Cancer

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ClinicalTrials.gov Identifier: NCT03090412
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : February 21, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:
This randomized phase II clinical trial studies how well photodynamic therapy with HPPH works compared to standard of care surgery in treating patients with oral cavity cancer. Photodynamic therapy can destroy or control disease by using a combination of drug, such as HPPH, and light and may be as effective as surgery in treating patients with oral cavity cancer.

Condition or disease Intervention/treatment Phase
Stage I Oral Cavity Squamous Cell Carcinoma Stage II Oral Cavity Squamous Cell Carcinoma Drug: HPPH Other: Laboratory Biomarker Analysis Drug: Photodynamic Therapy Other: Quality-of-Life Assessment Procedure: Therapeutic Conventional Surgery Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To test the non-inferiority of photodynamic therapy (PDT) to standard of care surgery by comparing the rate of tumor response after PDT to those observed after surgery, at 24 months post treatment.

SECONDARY OBJECTIVES:

I. To determine quality of life (QoL) at 6, 12, 18 and 24 months post PDT or surgery.

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).

TERTIARY OBJECTIVES:

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

OUTLINE: Patients are randomized to 1 of 2 treatment 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 and undergo PDT on day 1.

After completion of study treatment, patients are followed up every 3-4 months in year 1 and every 3-6 months in year 2.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Multicenter Phase II Study Using (2-1[Heyloxyethyl]-2-Devinylpyropheophorbide-a) (HPPH) With PDT Versus Standard of Care Surgery for Patients With T1/T2 N0 Squamous Cell Carcinoma of the Oral Cavity
Actual Study Start Date : March 30, 2017
Estimated Primary Completion Date : November 2, 2020
Estimated Study Completion Date : November 2, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm I (surgery)
Patients undergo standard of care surgery on day 1.
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Procedure: Therapeutic Conventional Surgery
Undergo standard of care surgery

Experimental: Arm II (HPPH, PDT)
Patients receive HPPH IV over 1 hour on day 0 and undergo PDT on day 1.
Drug: HPPH
Given IV
Other Name: Photochlor

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Photodynamic Therapy
Undergo PDT
Other Names:
  • PDT
  • Photoradiation Therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment




Primary Outcome Measures :
  1. Rate of tumor response as evaluated by Response Evaluation Criteria in Solid Tumors version 1.1 [ Time Frame: At 24 months ]
    Objective tumor response will be tabulated overall.


Secondary Outcome Measures :
  1. Change in quality of life as measured by the University of Washington Quality of Life questionnaire version 4 [ Time Frame: Baseline up to 24 months ]
    In the analysis of QoL simple data analyses will initially take place including individual participant-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. Once the model is fit, specific linear contrasts based on the estimated model parameters will be constructed and used to test hypotheses concerning between time points and between group comparisons

  2. Incidence of adverse events as graded by CTCAE version 4.0 [ Time Frame: Up to 30 days after administration of HPPH ]
    The frequency of toxicities will be tabulated by grade.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
  • Participants with previously untreated T1/T2 N0 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 (measured clinically and/or by computed tomography [CT] or magnetic resonance imaging [MRI] scan)
  • CT or MRI 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
  • Participants 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 is participating in this study, she should inform her treating physician immediately
  • Participant 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:

  • Those 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
  • Those with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
  • Those 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) or serum glutamic-oxaloacetic transaminase (SGOT) > 3 times the upper normal limit
  • Diagnostic biopsy reveals perineural invasion (PNI) and/or lymphovascular invasion (LVI)
  • 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 females
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
  • Received an investigational agent within 30 days prior to enrollment
  • Trismus or compromised airway
  • Previous treatment in the target tumor area

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090412


Locations
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Roswell Park    877-275-7724    AskRPCI@RoswellPark.org   
Principal Investigator: Hassan Arshad         
University of Rocherster Recruiting
Rochester, New York, United States, 14642
Contact: Paul Allen    585-275-1186    Paul_Allen@URMC.Rochester.edu   
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Hassan Arshad Roswell Park Cancer Institute

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT03090412     History of Changes
Other Study ID Numbers: I 33616
NCI-2017-00441 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 33616 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell