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Tyrosine Kinase Inhibitor
Gefitinib + PEG-Interferon for Skin Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Nontransplant patients with any degree of renal insufficiency allowed
Histologically or cytologically confirmed primary squamous cell carcinoma of the skin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying the side effects and best dose of the combination of PEG-interferon alfa-2a and gefitinib in treating patients with unresectable or metastatic skin cancer.
Who is the study for?
This trial is for adults with advanced skin cancer that can't be removed by surgery or cured with other treatments. Participants must have a certain level of blood cells, not be pregnant or breastfeeding, use contraception if fertile, and have a stable performance status. Those with HIV/AIDS or another controlled cancer may join. People who've had recent cancer treatment, severe illnesses, organ transplants (except stable kidney transplant patients), or used EGFR inhibitors are excluded.Check my eligibility
What is being tested?
The study is testing the combination of Gefitinib and PEG-Interferon Alfa-2a to see how well they work together against unresectable or metastatic skin cancer. It aims to find the best dose with acceptable side effects (phase I) and then assess its effectiveness in reducing tumor growth (phase II).See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as flu-like symptoms from PEG-Interferon Alfa-2a and issues like diarrhea and rash from Gefitinib due to enzyme inhibition in cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have kidney problems but haven't had a transplant.
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My skin cancer is confirmed as squamous cell carcinoma.
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No treatment can cure my condition without causing severe side effects.
Select...
My cancer has spread and cannot be removed by surgery.
Select...
I can take care of myself and perform light activities.
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I am living with HIV/AIDS.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quantification of rash after treatment with gefitinib for 1 month and after the addition of PEG-interferon alfa-2a to gefitinib
Response rate to treatment with gefitinib alone for 1 month
Response rate to treatment with gefitinib in combination with PEG-interferon alfa-2a
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Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,619 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,137 Total Patients Enrolled
1 Trials studying Non-melanoma Skin Cancer
138 Patients Enrolled for Non-melanoma Skin Cancer
William L. Read, MDStudy ChairUniversity of California, San Diego
3 Previous Clinical Trials
15 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The participant's disease can be measured.I have kidney problems but haven't had a transplant.Your bilirubin levels are not higher than 1.5 times the normal limit.I am not currently on any treatments for skin cancer.My skin cancer is confirmed as squamous cell carcinoma.Your white blood cell count is too high.I have another cancer type but it's under control and doesn't need active treatment.I have severe health issues or lab results, except for stable kidney problems as a transplant patient.I do not have any serious health or mental conditions that would stop me from following the study's requirements.I have not taken drugs like gefitinib, erlotinib, or cetuximab.I am not currently undergoing radiotherapy.No treatment can cure my condition without causing severe side effects.It has been over 30 days since my last experimental cancer treatment.Your platelet count is higher than 100,000 per cubic millimeter.I do not have any severe illnesses that are not under control.You must have a negative pregnancy test.My cancer has spread and cannot be removed by surgery.I can take care of myself and perform light activities.I am living with HIV/AIDS.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings in this clinical trial for participants?
"Clinicaltrials.gov confirms that this medical study, first posted on September 1st 2006 and last updated December 18th 2013, is no longer recruiting participants. Although the trial has concluded its recruitment effort, there are 158 other clinical trials currently enrolling patients."
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