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

NCT ID: NCT00025571

Last Updated: 2011-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-06-30
• Study Completion Date: 2004-10-31

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.

Conditions

Lung Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

HPPH

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Roswell Park Cancer Institute

Principal Investigators

Gregory M. Loewen, DO, FCCP

Role: STUDY_CHAIR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

RPCI-RP-0005

Identifier Type: -

Identifier Source: secondary_id

CDR0000068974

Identifier Type: -

Identifier Source: org_study_id