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

This study is currently recruiting participants.
Verified April 2014 by Roswell Park Cancer Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01854684
First received: May 13, 2013
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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 effective during surgery against non-small cell lung cancer.


Condition Intervention Phase
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
Drug: HPPH
Procedure: therapeutic conventional surgery
Other: photodynamic therapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Surgery Plus Intraoperative Photodynamic Therapy (PDT) With Temoporfin in Patients With Resectable Primary Non-Small Cell Lung Cancer (NSCLC) With Ipsilateral Thoracic Nodal (N1 or N2) or T3/T4 Disease

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Maximum tolerated dose of PDT with temoporfin, defined as the dose level in which more than 1 of 6 patients experience a dose limiting toxicity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.4 [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Locoregional recurrence-free rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Estimated using simple relative frequencies. The corresponding 95% confidence interval for the estimated probability will be computed using the method proposed by Clopper and Pearson. Maximum likelihood estimation will be utilized in the model fitting procedures.

  • Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Distribution will be obtained using the Kaplan-Meier method. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed.

  • Progression free survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Distribution will be obtained using the Kaplan-Meier method. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed.

  • Toxicity rate, using NCI CTCAE version 4 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    Estimated using simple relative frequencies. The corresponding 95% confidence interval for the estimated probability will be computed using the method proposed by Clopper and Pearson. Maximum likelihood estimation will be utilized in the model fitting procedures.


Estimated Enrollment: 12
Study Start Date: February 2014
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (surgery and intraoperative PDT)
Patients receive HPPH IV over 1 hour and then undergo standard surgical resection with intraoperative PDT.
Drug: HPPH
Given IV
Other Name: Photochlor
Procedure: therapeutic conventional surgery
Undergo surgical resection
Other: photodynamic therapy
Undergo intraoperative PDT
Other Names:
  • Light Infusion Therapy™
  • PDT
  • therapy, photodynamic

Detailed Description:

PRIMARY OBJECTIVES:

I. To demonstrate that intraoperative adjuvant regional photodynamic therapy with 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-hydroxyvitamin 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.

Subjects will receive tempoforin as outpatients but PDT will occur following outpatient surgery.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01854684

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: Chukwumere E. Nwogu         
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Chukwumere Nwogu Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01854684     History of Changes
Other Study ID Numbers: I 228112, NCI-2013-00886
Study First Received: May 13, 2013
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014