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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:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00675233
First received: May 8, 2008
Last updated: January 10, 2014
Last verified: January 2014
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Toxicity [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Tumor response [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: January 2008
Estimated Primary Completion Date: June 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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: Nestor R. Rigual, MD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00675233     History of Changes
Other Study ID Numbers: CDR0000595166, RPCI-I-119207
Study First Received: May 8, 2008
Last Updated: January 10, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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
Neoplasms by Site

ClinicalTrials.gov processed this record on November 24, 2014