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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00025571
• Other study ID #: CDR0000068974
• Secondary ID: RPCI-RP-0005
• Status: Completed
• Phase: Phase 1
• First received: October 11, 2001
• Last updated: March 3, 2011
• Start date: June 2001
• Est. completion date: October 2004

Study information

• Verified date: March 2011
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2004
• Est. primary completion date: October 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• HPPH

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States,