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

March 3, 2011 updated by: Roswell Park Cancer Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Investigators

  • Study Chair: Gregory M. Loewen, DO, FCCP, Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (Actual)

October 1, 2002

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

October 11, 2001

First Submitted That Met QC Criteria

June 24, 2003

First Posted (Estimate)

June 25, 2003

Study Record Updates

Last Update Posted (Estimate)

March 7, 2011

Last Update Submitted That Met QC Criteria

March 3, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068974
  • RPCI-RP-0005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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