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Photodynamic Therapy With HPPH in Treating Patients With Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Study NCT00025571   Information provided by National Cancer Institute (NCI)
First Received: October 11, 2001   Last Updated: July 23, 2008   History of Changes

October 11, 2001
July 23, 2008
June 2001
 
 
 
Complete list of historical versions of study NCT00025571 on ClinicalTrials.gov Archive Site
 
 
 
Photodynamic Therapy With HPPH in Treating Patients With Non-Small Cell Lung Cancer
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

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.

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.

Phase I
Interventional
Treatment
Lung Cancer
Drug: HPPH
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00025571
 
CDR0000068974, RPCI-RP-0005, NCI-G01-2023
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Study Chair: Gregory M. Loewen, DO, FCCP Roswell Park Cancer Institute
National Cancer Institute (NCI)
July 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP