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

Sponsor
Roswell Park Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00025571
Collaborator
(none)
1
Location
40
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
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
Study Start Date :
Jun 1, 2001
Actual Primary Completion Date :
Oct 1, 2002
Actual Study Completion Date :
Oct 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Roswell Park Cancer Institute Buffalo New York United States 14263-0001

    Sponsors and Collaborators

    • Roswell Park Cancer Institute

    Investigators

    • Study Chair: Gregory M. Loewen, DO, FCCP, Roswell Park Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00025571
    Other Study ID Numbers:
    • CDR0000068974
    • RPCI-RP-0005
    First Posted:
    Jun 25, 2003
    Last Update Posted:
    Mar 7, 2011
    Last Verified:
    Mar 1, 2011
    Keywords provided by , ,
    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
    Additional relevant MeSH terms:
    Lung Neoplasms

    Study Results

    No Results Posted as of Mar 7, 2011