Photodynamic Therapy Using HPPH in Treating Patients With Dysplasia, Cancer in Situ, or Invasive Cancer of the Larynx

This study is ongoing, but not recruiting participants.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00675233

First Posted: May 9, 2008

Last Update Posted: August 31, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Roswell Park Cancer Institute

Purpose

RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment for laryngeal cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of laser light therapy when given together with HPPH in treating patients with dysplasia, cancer in situ, or invasive cancer of the larynx.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: HPPH Procedure: laser therapy	Phase 1


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Phase I Trial of Photodynamic Therapy With HPPH (2-1[Hexyloxyethyl]-2-devinylpyropheophorbide-a) for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Larynx

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Laryngeal Cancer

U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:

Toxicity [ Time Frame: 6 weeks ]
Tumor response [ Time Frame: 3 months ]


Enrollment:	29
Actual Study Start Date:	April 25, 2008
Estimated Study Completion Date:	June 28, 2018
Primary Completion Date:	June 28, 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment PDT Patients undergo PDT comprising HPPH IV over 1 hour on day 1 followed by laser light to the tumor on day 2. At least 6 weeks later, patients achieving partial response, no response, or a geographical miss may undergo a second course of treatment.	Drug: HPPH Given IV Procedure: laser therapy Escalating light doses with 665 nm light

Detailed Description:

OBJECTIVES:

Primary

To determine the maximum tolerated dose of laser light therapy using a fixed dose of HPPH in patients with dysplasia, squamous cell carcinoma in situ, or T1 squamous cell carcinoma of the larynx.

Secondary

To determine response in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of laser light therapy.

Patients undergo photodynamic therapy comprising HPPH IV over 1 hour on day 1 and laser light therapy to the tumor on day 2. Approximately 8 weeks later, patients with a partial response, no response, or a geographical miss may receive a second course of treatment.

After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and then periodically thereafter.

Eligibility

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Biopsy-confirmed diagnosis of 1 of the following:
- Mild to severe dysplasia of the larynx
  - Dysplastic lesions > 3 mm in thickness
- Squamous cell carcinoma in situ of the larynx
- T1 squamous cell carcinoma of the larynx
  - Tumor > 3 mm in thickness
  - No T2-T4 squamous cell carcinoma of the larynx
Newly diagnosed or recurrent disease

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Total bilirubin > 2.0 mg/dL
Creatinine > 2.0 mg/dL
SGOT > 3 times upper limit of normal (ULN)
Alkaline phosphatase > 3 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3-6 months after completion of study treatment
No porphyria
No hypersensitivity to porphyrin or porphyrin-like compounds

PRIOR CONCURRENT THERAPY:

Any prior therapy allowed
At least 4 weeks since prior and no concurrent chemotherapy or radiotherapy

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00675233

Locations


United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001

Sponsors and Collaborators

Roswell Park Cancer Institute

Investigators


Principal Investigator:	Hassan Arshad, MD	Roswell Park Cancer Institute

More Information


Responsible Party:	Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00675233 History of Changes
Other Study ID Numbers:	CDR0000595166 I 119207
First Submitted:	May 8, 2008
First Posted:	May 9, 2008
Last Update Posted:	August 31, 2017
Last Verified:	August 2017

Keywords provided by Roswell Park Cancer Institute:


recurrent squamous cell carcinoma of the larynx stage I squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage 0 laryngeal cancer

Additional relevant MeSH terms:


Head and Neck Neoplasms Neoplasms by Site Neoplasms

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