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
18 Years
N/A
Both
Lung Cancer
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Gregory M. Loewen, DO, FCCP
Investigator Role:
Study Chair
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000068974
NCT ID:
NCT00025571
Start Date:
June 2001
Completion Date:
October 2004
Related Keywords:
- Lung Cancer
- 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
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
