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Photodynamic Therapy in Treating Patients With Recurrent, Refractory, or Second Primary Head and Neck Cancer That Cannot Be Treated With Surgery or Radiation Therapy

Primary Purpose

Head and Neck Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
temoporfin
Sponsored by
Quintiles, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring recurrent salivary gland cancer, recurrent metastatic squamous neck cancer with occult primary, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arkansas for Medical Sciences
  • H. Lee Moffitt Cancer Center and Research Institute
  • Division of Head and Neck Surgery
  • Norton Healthcare Pavilion
  • Ear, Nose, and Throat Specialty Care of Minnesota, P.A.
  • School of Dental Medicine
  • St. Luke's-Roosevelt Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
December 18, 2013
Sponsor
Quintiles, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00003856
Brief Title
Photodynamic Therapy in Treating Patients With Recurrent, Refractory, or Second Primary Head and Neck Cancer That Cannot Be Treated With Surgery or Radiation Therapy
Official Title
A Multicenter, Multi-National, Open-Label, Single Group, Single and Multiple Dose Study of Foscan-Mediated Photodynamic Therapy (PDT) for the Palliative Treatment of Recurrent, Refractory or Second Primary Squamous Cell Carcinomas of the Head and Neck in Patients Considered to be Incurable With Surgery or Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2001
Overall Recruitment Status
Unknown status
Study Start Date
October 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Quintiles, Inc.

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: I. Determine the individual clinical benefit of temoporfin-mediated photodynamic therapy for palliative treatment in patients with recurrent, refractory, or second primary squamous cell cancer of the head and neck. II. Determine the improvement in global, functional, and symptomatic measures of quality of life in these patients. III. Determine the toxic effects, tolerability, and safety of this regimen in these patients. IV. Determine the population pharmacokinetics, objective tumor response (complete and partial), and the 1 year survival of these patients on this regimen. OUTLINE: This is a multicenter study. Patients receive IV temoporfin on day -4, followed by laser light therapy on day 0. Patients are treated every 4 to 16 weeks for a maximum of 3 courses. Patients are evaluated on days 1, 2, 7, and weeks 2, 4, 6, 8, 12, and 16 following laser light therapy. Quality of life is assessed at baseline through week 12 of follow-up. Patients are followed monthly for 4 months after the final treatment, then every 3 months for 1 year. PROJECTED ACCRUAL: A minimum of 50 prospective and 25 retrospective patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
recurrent salivary gland cancer, recurrent metastatic squamous neck cancer with occult primary, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
temoporfin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Larson
Organizational Affiliation
Quintiles, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Division of Head and Neck Surgery
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Norton Healthcare Pavilion
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Ear, Nose, and Throat Specialty Care of Minnesota, P.A.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
School of Dental Medicine
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214-3008
Country
United States
Facility Name
St. Luke's-Roosevelt Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States

12. IPD Sharing Statement

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Photodynamic Therapy in Treating Patients With Recurrent, Refractory, or Second Primary Head and Neck Cancer That Cannot Be Treated With Surgery or Radiation Therapy

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