NCT00003856

Brief Summary

RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. This may be an effective palliative treatment for head and neck cancer. PURPOSE: Phase II trial to study the effectiveness of photodynamic therapy for palliative treatment in patients who have recurrent, refractory, or second primary head and neck cancer that cannot be treated with surgery or radiation therapy.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for phase_2 head-and-neck-cancer

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1998

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.6 years until next milestone

First Posted

Study publicly available on registry

June 3, 2004

Completed
Last Updated

December 19, 2013

Status Verified

January 1, 2001

First QC Date

November 1, 1999

Last Update Submit

December 18, 2013

Conditions

Head and Neck Cancer

Keywords

recurrent salivary gland cancerrecurrent metastatic squamous neck cancer with occult primaryrecurrent squamous cell carcinoma of the lip and oral cavityrecurrent squamous cell carcinoma of the oropharynxrecurrent squamous cell carcinoma of the nasopharynxrecurrent squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the larynxrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavity

Interventions

temoporfinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed recurrent, refractory, or second primary squamous cell cancer of the head and neck that is incurable with surgery or radiotherapy Any N, Any M, single or multiple tumor(s) Locally accessible, discrete tumor(s) by CT or MRI scan Must be considered incurable with surgery or radiotherapy, for example: Distant disease (e.g., lung and/or liver metastases) OR Cervical disease fixed to surrounding structures (e.g., carotid artery or prevertebral fascia) OR Metastases in the site of prior radiotherapy OR Not suitable for anesthesia or reconstructive surgery OR Multiple cutaneous metastases PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No disease exacerbated by light, including systemic lupus erythematosus, psoriasis, porphyria, actinic reticuloid, or xeroderma pigmentosum Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 30 days since prior chemotherapy (6 weeks since nitrosoureas) Endocrine therapy: Concurrent steroid therapy allowed Radiotherapy: At least 30 days since prior radiotherapy to the head and neck Surgery: At least 30 days since prior surgery and recovered Other: At least 30 days since prior light activated therapy or medication (e.g.,PUVA or Accutane) No prior photodynamic therapy At least 30 days since prior experimental drugs

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

Sponsors & Collaborators

Study Sites (7)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Division of Head and Neck Surgery

Evanston, Illinois, 60201, United States

Location

Norton Healthcare Pavilion

Louisville, Kentucky, 40202, United States

Location

Ear, Nose, and Throat Specialty Care of Minnesota, P.A.

Minneapolis, Minnesota, 55404, United States

Location

School of Dental Medicine

Buffalo, New York, 14214-3008, United States

Location

St. Luke's-Roosevelt Hospital

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSalivary Gland NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

temoporfin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Barbara Larson

    Quintiles, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 1, 1999

First Posted

June 3, 2004

Study Start

October 1, 1998

Last Updated

December 19, 2013

Record last verified: 2001-01

Locations

US(7)