Clinical trial NCT02245100: Circulating Tumor DNA in Predicting Outcomes in Patients With Stage IV Head and Neck Cancer or Stage III-IV Non-small Cell Lung Cancer
Official title: A Pilot Study to Evaluate the Predictive Value of Circulating Tumor DNA for Clinical Outcome in Patients With Advanced Head and Neck and Lung Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
Salivary Gland Squamous Cell Carcinoma
Stage IIIA Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Stage IV Squamous Cell Carcinoma of the Hypopharynx
Stage IV Squamous Cell Carcinoma of the Nasopharynx
Stage IVA Salivary Gland Cancer
Stage IVA Squamous Cell Carcinoma of the Larynx
Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IVA Squamous Cell Carcinoma of the Oropharynx
Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Stage IVA Verrucous Carcinoma of the Larynx
Stage IVA Verrucous Carcinoma of the Oral Cavity
Stage IVB Salivary Gland Cancer
Stage IVB Squamous Cell Carcinoma of the Larynx
Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IVB Squamous Cell Carcinoma of the Oropharynx
Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Stage IVB Verrucous Carcinoma of the Larynx
Stage IVB Verrucous Carcinoma of the Oral Cavity
Stage IVC Salivary Gland Cancer
Stage IVC Squamous Cell Carcinoma of the Larynx
Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IVC Squamous Cell Carcinoma of the Oropharynx
Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Stage IVC Verrucous Carcinoma of the Larynx
Stage IVC Verrucous Carcinoma of the Oral Cavity
Tongue Cancer
Untreated Metastatic Squamous Neck Cancer With Occult Primary
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2014-09-19
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with advanced head and neck carcinoma or NSCLC enrolled at Thomas Jefferson University

Brief summary: This pilot research trial studies circulating tumor deoxyribonucleic acid (DNA) in predicting outcomes in patients with stage IV head and neck cancer or stage III-IV non-small cell lung cancer. Studying circulating tumor DNA from patients with head and neck or lung cancer in the laboratory may help doctors predict how well patients will respond to treatment.

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate the predictive value of the circulating tumor DNA for disease-free survival/progression-free survival in patients with advanced head and neck carcinoma (HNC) and non-small cell lung cancer (NSCLC).

SECONDARY OBJECTIVES:

I. To correlate the levels of plasma tumor DNA with the salivary tumor DNA. II. To correlate the mutations found in the circulating tumor DNA with the mutations in the tumor tissues.

III. To evaluate the association between presence and absence of circulating tumor DNA mutation with the tumor burden assessed by using the radiological findings and pre-treatment fludeoxyglucose (FDG) positron emission tomography (PET)-derived metrics: metabolic tumor volume (MTV), maximum standardized uptake value (SUVmax), total glycolytic activity (TGA).

IV. To quantify tumor-specific exosomes from plasma. V. To evaluate the utility of cancer-derived exosomes to serve as prognostic biomarkers for real-time monitoring of therapeutic efficacy and identifying early recurrence using longitudinal samples from cancer patients undergoing treatment.

OUTLINE:

Patients undergo blood sample collection within 1 month before surgery, radiation therapy, or chemotherapy; within 1 week after surgical resection (for patients having upfront surgery); within 1 month before beginning of post-operative radiation therapy (for patients having upfront surgery); during the second week of radiation therapy, during the last week of radiation therapy; and at 1 and 3 months after radiation therapy and then every 3 months for up to 18 months. Patients also undergo saliva sample collection within 1 month before surgery, radiation therapy, chemoradiation therapy, or system chemotherapy and tissue collection at the time of surgery (if upfront surgery is indicated). Blood, saliva, and tissue samples are analyzed for tumor mutations via next generation sequencing.

Eligibility criteria: Inclusion Criteria:

1. Patients older than 18 years age
2. Diagnosis of advanced HNC (Stage III, IVA, IVB, IVC) or NSCLC (Stage IIA, IIB, IIIA, IIIB, IV) (patients with synchronous advanced HNC and NSCLC are eligible)
3. ECOG performance status score of 0-3
4. Life expectancy of 3 months or longer
5. Patients able to provide a written informed consent prior to study entry

Exclusion Criteria:

1. Prior chemotherapy or full course of radiotherapy for their present advanced HNC or NSCLC
2. Patients are excluded if they have a history of any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated basal or squamous cell carcinoma of skin
3. Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation, and in the judgment of the investigator would make the subject inappropriate for entry into this study

Primary outcomes:
measure: Predictive value of circulating tumor DNA for disease-free survival (DFS)/progression-free survival (PFS)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Correlation between plasma tumor DNA levels and salivary tumor DNA levels
timeFrame: Up to 2 years
measure: Association between absence and presence of circulating tumor DNA mutation with the tumor burden
timeFrame: Up to 2 years
measure: Association between absence and presence of circulating tumor DNA mutation with FDG-PET tumor hypermetabolism status
timeFrame: Up to 2 years
measure: Correlation between mutations found in plasma and tissue mutations
timeFrame: Up to 2 years
measure: Correlation between circulating tumor cells and circulating tumor DNA
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Voichita Bar-Ad, MD
role: PRINCIPAL_INVESTIGATOR
References: