Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors

NCT ID: NCT00060268

Last Updated: 2011-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-01-31
• Study Completion Date: 2004-06-30

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/II trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have obstructive esophageal tumors.

Detailed Description

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.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT

Interventions

HPPH

iv

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Roswell Park Cancer Institute

Principal Investigators

Hector R. Nava, MD, FACS

Role: STUDY_CHAIR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

RPCI-DS-9701

Identifier Type: -

Identifier Source: secondary_id

CDR0000301589

Identifier Type: -

Identifier Source: org_study_id