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

Sponsors and Collaborators:	Roswell Park Cancer Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
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

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

June 2001

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

National Cancer Institute (NCI)

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

Study ID Numbers:	CDR0000068974, RPCI-RP-0005, NCI-G01-2023
Study First Received:	October 11, 2001
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00025571 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer

Adenocarcinoma of Lung
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 07, 2009