Neoplasms

All Conditions

Mouth and Tooth Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Mouth Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Oral Squamous Cell Carcinoma

Oral Cancer

Patients undergo standard of care surgery on day 1.

Patients receive HPPH IV over 1 hour on day 0 and undergo PDT on day 1.

HPPH

Laboratory Biomarker Analysis

Photodynamic Therapy

Quality-of-Life Assessment

Therapeutic Conventional Surgery

Jon Chan

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.

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.

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

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

Objective tumor response will be tabulated overall.

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

The frequency of toxicities will be tabulated by grade.

National Cancer Institute (NCI)

Roswell Park Cancer Institute

Patients undergo standard of care surgery on day 1.

Quality-of-Life Assessment: Ancillary studies

Therapeutic Conventional Surgery: Undergo standard of care surgery

Arm I (Surgery)

Patients receive HPPH IV over 1 hour on day 0 and undergo PDT on day 1.

HPPH: Given IV

Laboratory Biomarker Analysis: Correlative studies

Photodynamic Therapy: Undergo PDT

Quality-of-Life Assessment: Ancillary studies

Arm II (HPPH, PDT)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Katy Wang

Due to PI departure and early termination with few patients, only the counts of events have been calculated and no testing was done

Rate of Tumor Response as Evaluated by Response Evaluation Criteria in Solid Tumors Version 1.1

Due to PI departure with few patients, only the counts of events have been calculated and no testing was done..

Change in Quality of Life as Measured by the University of Washington Quality of Life Questionnaire Version 4

Due to PI departure with few patients, only the counts of events have been calculated and no tabulation was done..

Adverse Events as Graded by CTCAE Version 4.0 Are Reported

Overall Study

Infections

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Papilloma

Communicable Diseases

Virus Diseases

Papillomavirus Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Durvalumab

Immunoglobulins

Immunoglobulin G

Immunoglobulins, Intravenous

Antibodies, Monoclonal

Antineoplastic Agents, Immunological

Immunologic Factors

Patients receive durvalumab IV over approximately 60 minutes on day 1. Treatment repeats every 2 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 3-17 days after last dose administration of durvalumab, patients undergo surgery. Patients may receive an additional dose of durvalumab if time to surgery is longer than 30 days.

Mercedes Porosnicu

This pilot clinical trial studies how well durvalumab before surgery works in treating patients with oral cavity or oropharynx cancer. Monoclonal antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and spread.

PRIMARY OBJECTIVES:

I. To investigate the effect of durvalumab on local and systemic immune activation by HPV status in patients with oral cavity and oropharynx head and neck squamous cell carcinoma (HNSCC).

II. To examine the effects of durvalumab on systemic immune response to HPV and tumor associated antigens.

III. To examine the effects of durvalumab on immune regulatory mechanisms. IV. To explore the association between levels of immune-regulatory micro-ribonucleic acid (miR) in plasma and saliva and immune response.

SECONDARY OBJECTIVES:

I. Investigate the effect of the treatment with durvalumab on the computed tomography (CT) scan and positron emission tomography (PET) scan response.

II. Evaluate the safety of a short induction treatment with durvalumab.

OUTLINE:

Patients receive durvalumab intravenously (IV) over approximately 60 minutes on day 1. Treatment repeats every 2 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 3-17 days after last dose administration of durvalumab, patients undergo surgery. Patients may receive an additional dose of durvalumab if time to surgery is longer than 30 days.

After completion of study treatment, patients are followed up for 90 days.

Durvalumab Before Surgery in Treating Patients With Oral Cavity or Oropharynx Cancer

Pilot Study to Evaluate the Anti-Tumor Effect of Durvalumab (Medi4736) in Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN), Human Papilloma Virus (HPV) Positive Versus Negative, When Treated Before Surgery

Concentration of certain immune effector will be assessed in blood pre- and post- treatment. Descriptive statistics, confidence intervals will be calculated and 2-sample t-tests will be performed. Tumor-infiltrating immune-regulator and effector cells will be quantified (0 to 3+) using standing immunofluorescence techniques. Counts and percents will be calculated for these measures overall and by HPV (+/-) groups pre- and post-treatment. Fisher exact tests will be used to compare groups at pre- and post- treatment. Stuart-Maxwell tests (generalizations of the McNemar's Tes

Levels of immune-regulatory miRs assessed in blood, saliva and tumor tissue will be assessed pre- and post- treatments. Descriptive statistics, confidence intervals will be calculated and 2-sample t-tests will be performed. In addition, correlations between the different methods will be examined (i.e., correlation between saliva and blood measures, saliva and tumor measures, and blood and tumor measures).

Lab results will be compared between patients who are HPV+ and HPV- using 2 sample t-tests. These measures will be compared in several ways. First, baseline, pre-treatment levels will be examined using descriptive statistics (n, mean, standard deviations, range). These measures will be examined overall and by HPV (+/-) groups. For each measure, and time point, 95% confidence intervals will be estimated. Next, two sample t-tests will be performed to compare levels of the measures at baseline. Next, measures taken post-treatment will be examined in a similar manner (descriptive statistics and 2-

Concentration of certain regulatory cells will be assessed in blood pre- and post- treatment. Descriptive statistics, confidence intervals will be calculated and 2-sample t-tests will be performed. Tumor-infiltrating immune-regulator and effector cells will be quantified (0 to 3+) using standing immunofluorescence techniques. Counts and percents will be calculated for these measures overall and by HPV (+/-) groups pre- and post-treatment. Fisher exact tests will be used to compare groups at pre- and post- treatment. Stuart-Maxwell tests (generalizations of the McNemar's Tes

AEs will be coded using the Medical Dictionary for Regulatory Activities to their organ class by preferred term. Coded AEs will be displayed by frequency, severity, and relationship to treatment (durvalumab) in the safety population. In addition, summary tables will be generated for the following situations: 1. fatigue, diarrhea, nausea and skin rash; 2. Immune-mediated reactions of any grade; 3. other adverse events graded as 3 or more by CTCAE Version 4.03; 4) Durvalumab dose reductions; 5) discontinuations of treatment with durvalumab, with specification of reason for discontinuation; and 6

SUV activity as measured by PET scans will also be compared between groups at each time point and descriptive statistics, confidence intervals will be calculated and 2-sample t-tests will be performed.

Tumor volumes will be compared between groups (HPV +/-) pre- and post- treatment. Descriptive statistics, confidence intervals will be calculated and 2-sample t-tests will be performed

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Photodynamic Therapy With HPPH Compared to Standard of Care Surgery in Treating Patients With Oral Cavity Cancer	NCT03090412	Stage I Oral Ca... Stage II Oral C...	HPPH Laboratory Biom... Photodynamic Th... Quality-of-Life... Therapeutic Con...	18 Years -	Roswell Park Cancer Institute
Durvalumab Before Surgery in Treating Patients With Oral Cavity or Oropharynx Cancer	NCT02827838	Human Papilloma... Stage I Oral Ca... Stage I Orophar... Stage II Oral C... Stage II Oropha... Stage III Oral ... Stage III Oroph... Stage IVA Oral ... Stage IVA Oroph... Stage IVB Oral ... Stage IVB Oroph... Stage IVC Oroph...	Durvalumab Laboratory Biom... Therapeutic Con...	18 Years -	Wake Forest University Health Sciences
Durvalumab Before Surgery in Treating Patients With Oral Cavity or Oropharynx Cancer	NCT02827838	Human Papilloma... Stage I Oral Ca... Stage I Orophar... Stage II Oral C... Stage II Oropha... Stage III Oral ... Stage III Oroph... Stage IVA Oral ... Stage IVA Oroph... Stage IVB Oral ... Stage IVB Oroph... Stage IVC Oroph...	Durvalumab Laboratory Biom... Therapeutic Con...	18 Years -	Wake Forest University Health Sciences
Durvalumab Before Surgery in Treating Patients With Oral Cavity or Oropharynx Cancer	NCT02827838	Human Papilloma... Stage I Oral Ca... Stage I Orophar... Stage II Oral C... Stage II Oropha... Stage III Oral ... Stage III Oroph... Stage IVA Oral ... Stage IVA Oroph... Stage IVB Oral ... Stage IVB Oroph... Stage IVC Oroph...	Durvalumab Laboratory Biom... Therapeutic Con...	18 Years -	Wake Forest University Health Sciences

Spots Global Cancer Trial Database for stage ii oral cavity squamous cell carcinoma