Know Cancer

or
forgot password

A Phase I/II Trial for Treatment of Obstructive Esophageal Tumors by Photodynamic Therapy (PDT) Using 2-(1-Hydroxyethyl)-2-Devinylpyropheophorbide-a (HPPH)


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer

Thank you

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 InstituteBuffalo, New York  14263