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

NCT00675233 | Completed Phase 1 DMC

• 2 other identifiers: CDR0000595166I 119207
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Toxicity

  6 weeks

• Tumor response

  3 months

Study Arms (1)

Treatment PDT

EXPERIMENTAL

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; Procedure: laser therapy

Interventions

HPPH DRUG

Given IV

Treatment PDT

laser therapy PROCEDURE

Escalating light doses with 665 nm light

Treatment PDT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Laryngeal Neoplasms

Interventions

2-(1-hexyloxyethyl)-2-devinyl pyropheophorbide-a; Laser Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Otorhinolaryngologic Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Hassan Arshad, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 9, 2008
• Study Start: April 25, 2008
• Primary Completion: June 28, 2013
• Study Completion: September 27, 2018
• Last Updated: October 17, 2018

Record last verified: 2018-10

Locations

US (1)