A Phase I/II Trial for Treatment of Obstructive Esophageal Tumors by Photodynamic Therapy (PDT) Using 2-(1-Hydroxyethyl)-2-Devinylpyropheophorbide-a (HPPH)
18 Years
N/A
Both
Esophageal Cancer
Trial Information
A Phase I/II Trial for Treatment of Obstructive Esophageal Tumors by Photodynamic Therapy (PDT) Using 2-(1-Hydroxyethyl)-2-Devinylpyropheophorbide-a (HPPH)
OBJECTIVES:
- Determine, preliminarily, the safety of HPPH in patients with obstructive esophageal
tumors undergoing photodynamic therapy.
- Determine, preliminarily, tumor response in patients treated with this drug.
- Determine the length of time for cutaneous photosensitivity at the various drug doses
in these patients.
- Determine plasma clearance rates for this drug in these patients.
OUTLINE: This is a dose-escalation study.
- Phase I: Patients receive HPPH IV over 1 hour on day 1. Patients then undergo laser
light therapy on day 2.
Cohorts of 3 patients receive escalating doses of HPPH and a single light dose until the
optimal dose is determined. The optimal dose is defined as the minimum dose producing
efficacy without unacceptable toxicity.
- Phase II: Patients receive treatment as in phase I at the optimal dose. Patients are
followed monthly for 6-24 months.
PROJECTED ACCRUAL: A total of 9-14 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed esophageal cancer
- Stages T1-T3, any N, any M
- Tumor partially or completely obstructing the esophagus
- Primary or recurrent tumor meeting 1 of the following criteria for treatment:
- Patient is too debilitated for or refused conventional therapy
- Recurred after or failed to respond to chemotherapy, radiotherapy, or surgery
- Deemed most appropriately treated by photodynamic therapy (PDT) in the opinion
of the physician
- Persistent symptomatic disease required in patients who received prior radiotherapy,
chemotherapy, or PDT with photofrin or HPPH
- Prior PDT with HPPH allowed only if tumor is evident outside of the original
treatment site
- No tracheal or bronchial involvement by bronchoscopy
- No T4 lesions involving the aorta, lung, or pericardium by CT scan, MRI, or
endoscopic ultrasonography
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
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
Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No contraindications to endoscopy
- No porphyria
- No hypersensitivity to porphyrins
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- More than 4 weeks since prior chemotherapy
- No concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery
- Not specified
Other
- No concurrent photosensitizing agents (e.g., tetracyclines, sulfonamides,
phenothiazines, sulfonylureas, hypoglycemic agents, thiazide diuretics, and
griseofulvin)
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Primary Purpose: Treatment
Principal Investigator
Hector R. Nava, MD, FACS
Investigator Role:
Study Chair
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000301589
NCT ID:
NCT00060268
Start Date:
January 1997
Completion Date:
June 2004
Related Keywords:
- Esophageal Cancer
- recurrent esophageal cancer
- stage I esophageal cancer
- stage II esophageal cancer
- stage III esophageal cancer
- stage IV esophageal cancer
- Esophageal Diseases
- Esophageal Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
