Photodynamic Therapy Using HPPH in Treating Patients With Stage 0 Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified March 2013 by Roswell Park Cancer Institute
Sponsor:
Roswell Park Cancer Institute
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00526461
First received: September 5, 2007
Last updated: March 7, 2013
Last verified: March 2013
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Purpose
RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells. The drug becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed.
PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using HPPH in treating patients with stage 0 non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: HPPH |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study Light Dose for Photodynamic Therapy (PDT) Using 2-[1-hexyloxyethyl]-2 Devinyl Pyropheophorbide-a (HPPH) for Treatment of Non-Small Cell Carcinoma in Situ or Non-Small Cell Microinvasive Bronchogenic Carcinoma: A Dose Ranging Study |
Resource links provided by NLM:
Further study details as provided by Roswell Park Cancer Institute:
Primary Outcome Measures:
- Toxicity as measured by NCI CTC v2.0 [ Time Frame: Daily while in-house, weekly after discharge, at 4-6 weeks and at 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Tumor response [ Time Frame: At 4-6 weeks and 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 18 |
| Study Start Date: | February 2004 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PDT using HPPH
Patients receive HPPH IV over 1 hour on day 1. Patients then receive photodynamic therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for endoscopic debridement on day 5.
|
Drug: HPPH
IV
|
Detailed Description:
OBJECTIVES:
Primary
- To determine the maximally tolerated light dose (MTID) in patients with bronchogenic carcinoma in situ (CIS) or bronchogenic microinvasive carcinoma.
- To identify the systemic and normal tissue toxicity resulting from photodynamic therapy using HPPH in these patients.
Secondary
- To study tumor response in these patients.
OUTLINE: Patients receive HPPH IV over 1 hour on day 1. Approximately 2 days later, patients undergo photodynamic therapy (PDT) using laser light passed through the biopsy channel of an endoscope. Patients undergo endoscopic debridement on day 5. If viable tumor is found outside of the initial treatment area, patients may receive another dose of laser light without additional HPPH at that time.
After completion of study treatment, patients are followed at 4-6 weeks, 6 months, and periodically thereafter.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Biopsy confirmed carcinoma in situ (CIS) or microinvasive bronchogenic non-small cell lung carcinoma
- May have squamous cell carcinoma, adenocarcinoma, or large cell carcinoma histology
Stage 0 (CIS or microinvasive) disease, meeting all of the following criteria:
- Lesion must be radiographically occult and not definable by conventional CT scan of the chest
- Lesion may or may not be invisible on white light bronchoscopy, but is definable and photographable on laser-induced fluorescence emission (LIFE) bronchoscopy
- Biopsy of the lesion must indicate no evidence of invasion beyond cartilage on histopathology, but may be invasive through the basement membrane (microinvasive carcinoma)
- No evidence of major pulmonary vessel encasement on CT scan of the chest
PATIENT CHARACTERISTICS:
- Karnofsky performance status (PS) 50-100% OR ECOG PS 0-2
- Platelet count ≥ 100,000/mm^3
- WBC ≥ 4,000/mm^3
- Prothrombin time ≤ 1.5 times upper limit of normal (ULN)
- Total bilirubin ≤ 3.0 mg/dL
- Creatinine ≤ 3.0 mg/dL
- Alkaline phosphatase (hepatic) or SGOT ≤ 3 times ULN
- No porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
- No severe chronic obstructive pulmonary disease, that in the opinion of the investigator, would preclude multiple bronchoscopies or partial central airway obstruction from mucous/debris formation
- Patients with underlying lung disease must be judged (by the principal investigator) able to withstand mucous or debris formation at the site of treatment
- No contraindications for bronchoscopy
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- More than 4 weeks since prior and no concurrent chemotherapy or radiotherapy
- Prior therapy of any type (e.g., chemotherapy or radiotherapy) allowed for lung cancer
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00526461
Locations
| United States, New York | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263-0001 | |
| Contact: AskRPCI 877-275-7724 AskRPCI@RoswellPark.org | |
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
| Principal Investigator: | Samjot Dhillon, MD | Roswell Park Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Roswell Park Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00526461 History of Changes |
| Other Study ID Numbers: | CDR0000563238, RPCI-I-05903 |
| Study First Received: | September 5, 2007 |
| Last Updated: | March 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Roswell Park Cancer Institute:
|
stage 0 non-small cell lung cancer adenocarcinoma of the lung squamous cell lung cancer large cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Neoplasms Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013