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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HPPH
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 11, 2001
Last Updated
March 3, 2011
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00025571
Brief Title
Photodynamic Therapy With HPPH in Treating Patients With Non-Small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
October 2002 (Actual)
Study Completion Date
October 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
HPPH

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory M. Loewen, DO, FCCP
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

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

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