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A Phase I Study of Photodynamic Therapy (PDT) Combined With High Dose Rate (HDR) Brachytherapy for Patients With Obstructive Bronchogenic Carcinoma


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) Combined With High Dose Rate (HDR) Brachytherapy for Patients With Obstructive Bronchogenic Carcinoma


OBJECTIVES: I. Determine the feasibility, toxicity, and effectiveness of combination therapy
with Photofrin PDT and HDT brachytherapy in patients with endobronchial obstructions from
lung cancer.

OUTLINE: This is not a randomized study. Photofrin solution is administered slowly as a
bolus injection over 3-5 minutes on day 1. Bronchoscopy is performed under general
anesthesia 48 hours after Photofrin injection. Light is transmitted from the laser to the
tumor via quartz fiber optics (interstitial or surface PDT). Another bronchoscopy is
performed 48 hours after PDT treatment to clean out any tissue debris left after PDT
treatment. HDR brachytherapy is performed using prescribed dose of radiation for 5-10
minutes to designated positions. Repeat bronchoscopy is performed 3-4 weeks post HDR
brachytherapy and a second HDR brachytherapy treatment may be given. Patients are followed
every 3 months until death, or for 5 years.

PROJECTED ACCRUAL: 16 patients will be entered over 1.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed small cell or non-small cell primary
lung cancer with symptomatic endobronchial lesion(s) partially or totally obstructing
airway distal to the carina and accessible by endoscopy Recurrent disease following prior
therapy and/or be ineligible for, or refuse, alternative standard therapy such as: Surgery
External radiation therapy Chemotherapy High grade obstruction necessitating more rapid
aeration and palliation than standard therapy can provide No evidence of encasement or
extension of the tumor to the right or left major pulmonary vessels on CT of the chest No
tumor involvement at trachea or carina

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin less than 2 times the upper limit of normal SGOT/SGPT less than 2 times
the upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant
Adequate method of contraception required of all fertile patients Female fertile patients
must have normal serum beta HCG Not eligible for standard therapy and/or other protocol
therapy No hypersensitivity to DHE or other porphyrins Not concurrent photosensitizing
drugs such as: Tetracycline Doxorubicin No contraindications to general anesthesia,
including EKG abnormalities suggestive of acute ischemia

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No chemotherapy
within 3 weeks prior to study entry No doxorubicin within 8 weeks prior to study entry
Endocrine therapy: Not specified Radiotherapy: Prior radiation therapy dose no higher than
75 Gy to proposed bronchial segment allowed No concurrent external brain radiation therapy
Surgery: Not specified

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: Federal Government

Study ID:

DS 92-40

NCT ID:

NCT00014066

Start Date:

March 1993

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • limited stage small cell lung cancer
  • recurrent small cell lung cancer
  • stage 0 non-small cell lung cancer
  • Carcinoma, Bronchogenic
  • Lung Neoplasms

Name

Location
Roswell Park Cancer Institute Buffalo, New York  14263