Photodynamic Therapy Using HPPH in Treating Patients With Dysplasia, Cancer in Situ, or Invasive Cancer of the Larynx
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/19/2018 |
| Start Date: | April 25, 2008 |
| End Date: | September 27, 2018 |
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.
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.
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.
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
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