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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

May 8, 2008
January 10, 2014
January 2008
June 2014   (final data collection date for primary outcome measure)
  • Toxicity [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Tumor response [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Tumor response [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00675233 on ClinicalTrials.gov Archive Site
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Photodynamic Therapy Using HPPH in Treating Patients With Dysplasia, Cancer in Situ, or Invasive Cancer of the Larynx
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

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
  • Drug: HPPH
    Given IV
  • Procedure: laser therapy
    Escalating light doses with 665 nm light
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.
Interventions:
  • Drug: HPPH
  • Procedure: laser therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
Not Provided
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00675233
CDR0000595166, RPCI-I-119207
Yes
Roswell Park Cancer Institute
Roswell Park Cancer Institute
Not Provided
Principal Investigator: Nestor R. Rigual, MD Roswell Park Cancer Institute
Roswell Park Cancer Institute
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP