NCT00002963

Brief Summary

RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy using aminolevulinic acid cream may be effective in treating patients with skin cancer. PURPOSE: This randomized phase II trial is studying how well photodynamic therapy works in treating patients with skin cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Nov 1993

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 1993

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

Enrollment Period

13.6 years

First QC Date

November 1, 1999

Last Update Submit

January 30, 2013

Conditions

Non-melanomatous Skin Cancer

Keywords

basal cell carcinoma of the skinsquamous cell carcinoma of the skin

Outcome Measures

Primary Outcomes (1)

  • Depth of penetration of aminolevulinic acid as measured by the accumulation of protoporphyrin IX

Interventions

aminolevulinic acid hydrochlorideDRUG
conventional surgeryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven basal cell carcinoma or squamous cell carcinoma * Candidate for complete surgical excision PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No inflammation or infection of treated area PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Biopsy at least 2 weeks prior to surgery

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

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Levulinic AcidsKeto AcidsCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Allan R. Oseroff, MD, PhD

    Roswell Park Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

November 1, 1993

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

January 31, 2013

Record last verified: 2013-01

Locations

US(1)