Photodynamic Therapy With HPPH in Treating Patients With Non-Small Cell Lung Cancer - Full Text View

Sponsor:	Roswell Park Cancer Institute
Information provided by:	Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00025571

Purpose

RATIONALE: Photodynamic therapy uses light and drugs that make tumor cells more sensitive to light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by tumor cells and, when exposed to light, become active and kill the tumor cells.

PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have non-small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Drug: HPPH	Phase I

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	A Phase I Study of Photodynamic Therapy (PDT) Using 2-(1-hexyloxyethyl)-2 Devinyl Pyropheophorbide-a (HPPH) for Treatment of Early Stage Lung Cancer - A Dose Ranging Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Study Start Date:	June 2001
Study Completion Date:	October 2004
Primary Completion Date:	October 2002 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the systemic and normal tissue toxicity of photodynamic therapy with HPPH in patients with early stage or centrally obstructing non-small cell lung cancer.
Determine, preliminarily, the efficacy of this regimen in these patients.

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

Patients receive HPPH IV over 1 hour on day 1. Patients undergo laser light therapy via bronchoscopy on day 3.

Cohorts of 3-6 patients receive escalating doses of HPPH until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed for at least 6 months.

PROJECTED ACCRUAL: Approximately 15-17 patients will be accrued for this study within 2 years.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed microinvasive or centrally obstructing non-small cell lung cancer
- Squamous cell carcinoma
- Adenocarcinoma
- Large cell carcinoma

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Karnofsky 50-100% OR
ECOG 0-2

Life expectancy:

Not specified

Hematopoietic:

WBC at least 2,000/mm^3
Platelet count at least 50,000/mm^3

Hepatic:

Bilirubin no greater than 3.0 mg/dL
Alkaline phosphatase no greater than 3 times upper limit of normal (ULN)
SGOT no greater than 3 times ULN
PT no greater than 1.5 times ULN

Renal:

Creatinine no greater than 3.0 mg/dL

Pulmonary:

No severe chronic obstructive pulmonary disease that would preclude study

Other:

Not pregnant
Fertile patients must use effective contraception
No contraindications to bronchoscopy
No porphyria
No hypersensitivity to porphyrin or porphyrin-like compounds

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Prior biologic therapy for lung cancer allowed

Chemotherapy:

At least 4 weeks since prior chemotherapy
No concurrent chemotherapy

Endocrine therapy:

Prior endocrine therapy for lung cancer allowed

Radiotherapy:

At least 4 weeks since prior radiotherapy
No concurrent external beam radiotherapy

Surgery:

No concurrent surgery

Other:

Prior therapy for lung cancer allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00025571

Locations

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001

Sponsors and Collaborators

Roswell Park Cancer Institute

Investigators

Study Chair:

Gregory M. Loewen, DO, FCCP

Roswell Park Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Gregory Loewen, MD, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00025571 History of Changes
Other Study ID Numbers:	CDR0000068974, RPCI-RP-0005
Study First Received:	October 11, 2001
Last Updated:	March 3, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:

squamous cell lung cancer
large cell lung cancer
adenocarcinoma of the lung
stage I non-small cell lung cancer
stage II non-small cell lung cancer

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 February 12, 2012