Photodynamic Therapy During Surgery in Treating Patients With Non-small Cell Lung Cancer That Can Be Removed by Surgery

Roswell Park Comprehensive Cancer Center

Status and phase

Completed

Phase 1

Conditions

Stage IIA Non-Small Cell Lung Carcinoma

Recurrent Non-Small Cell Lung Carcinoma

Stage IIB Non-Small Cell Lung Carcinoma

Stage IIIA Non-Small Cell Lung Cancer

Stage IIIB Non-Small Cell Lung Cancer

Treatments

Other: Pharmacological Study

Drug: Photodynamic Therapy

Other: Laboratory Biomarker Analysis

Procedure: Therapeutic Conventional Surgery

Drug: Temoporfin

Study type

Interventional

Funder types

Other

Identifiers

NCT01854684

I 228112 (Other Identifier)

NCI-2013-00886 (Registry Identifier)

Details and patient eligibility

About

This phase I trial studies the side effects and best dose of photodynamic therapy during surgery in treating patients with non-small cell lung cancer that can be removed by surgery. Photodynamic therapy uses a drug, such as temoporfin, 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 a better way to treat patients with non-small cell lung cancer.

Full description

PRIMARY OBJECTIVES:

I. To demonstrate that intraoperative adjuvant regional photodynamic therapy with low-dose temoporfin is safe.

SECONDARY OBJECTIVES:

I. Initial assessment of efficacy (i.e., 2-year disease free survival). II. To investigate the relationship between signal transducer and activator of transcription 3 (STAT3) levels, measured light dose and the clinical outcome.

III. Correlate the serum concentrations of vitamin D metabolites (25-hydroxyvitarnin D3 and 1,25-dihydroxyvitamin D3) with the presence of lymph node (LN) metastasis at the time of surgical resection.

IV. To measure temoporfin uptake in malignant and normal tissue.

OUTLINE: This is a dose-escalation study of photodynamic therapy with temoporfin.

Patients receive temoporfin intravenously (IV) over no less than 6 minutes and then undergo standard surgical resection with intraoperative photodynamic therapy (PDT).

After completion of study treatment, patients are followed up every 6 months for 2 years.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically confirmed non-small cell lung cancer (NSCLC)
Patients with resectable primary NSCLC who are undergoing surgery to resect T3 to T4 lesions OR any patients with clinical NI or N2 disease regardless of T-stage
Subjects must have an Eastern Cooperative Oncology Group (ECOG) scale of 0-2
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 6 months after surgery; 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
The subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent prior to receiving any study related procedure
Must consent to participate in study I 03103: Roswell Park Cancer Institute (RPCI) Data Bank and Biorepository (DBBR)

Exclusion criteria

Patients who have had chemotherapy or radiotherapy 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 cell (WBC) < 4,000
Platelet count < 100,000
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
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
Any condition which in the Investigator's opinion deems the subject an unsuitable candidate to receive study drug
Received an investigational agent within 30 days prior to enrollment