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A Phase I Study of Surgery Plus Intraoperative Photodynamic Therapy (PDT) in Patients With Resectable Primary Non-Small Cell Lung Cancer (NSCLC) With Ipsilateral Thoracic Nodal (N1 or N2) or T3/T4 Disease


Phase 1
18 Years
N/A
Not Enrolling
Both
Recurrent Non-small Cell Lung Cancer, Stage IIA Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer

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Trial Information

A Phase I Study of Surgery Plus Intraoperative Photodynamic Therapy (PDT) in Patients With Resectable Primary Non-Small Cell Lung Cancer (NSCLC) With Ipsilateral Thoracic Nodal (N1 or N2) or T3/T4 Disease


PRIMARY OBJECTIVES:

I. To demonstrate that intraoperative adjuvant regional photodynamic therapy with HPPH 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 HPPH uptake in malignant and normal tissue.

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

Patients receive HPPH intravenously (IV) over 1 hour 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.


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 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

- 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

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

- Prothrombin time 1.5 times above the upper normal limit

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD) of PDT with HPPH, defined as the dose level in which more than 1 of 6 patients experience a dose limiting toxicity (DLT) using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4

Outcome Time Frame:

2 weeks

Safety Issue:

Yes

Principal Investigator

Chukwumere Nwogu

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

I 228112

NCT ID:

NCT01854684

Start Date:

May 2013

Completion Date:

Related Keywords:

  • Recurrent Non-Small Cell Lung Cancer
  • Stage IIA Non-small Cell Lung Cancer
  • Stage IIB Non-small Cell Lung Cancer
  • Stage IIIA Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Roswell Park Cancer Institute Buffalo, New York  14263