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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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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 InstituteBuffalo, New York  14263