Clinical trial · Interventional
Gefitinib and PEG-Interferon Alfa-2a in Treating Patients With Unresectable or Metastatic Skin Cancer
A Phase I/II Pilot Study of Bioimmunotherapy With IRESSA (Gefitinib) and Pegylated Interferon Alpha-2a for Patients With Unresectable/Metastatic Squamous Cell Carcinoma of the Skin
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PEG-interferon alfa-2a may interfere with the growth of tumor cells and slow the growth of skin cancer. Giving gefitinib together with PEG-interferon alfa-2a may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of PEG-interferon alfa-2a when given together with gefitinib and to see how well they work in treating patients with unresectable or metastatic skin cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-melanomatous Skin Cancer | Skin Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gefitinib | Drug | Gefitinib | ALIAS |
| PEG-interferon alfa-2a | Biological | Peginterferon Alfa-2a | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Tolerability
- measure
- Response rate to treatment with gefitinib alone for 1 month
- measure
- Response rate to treatment with gefitinib in combination with PEG-interferon alfa-2a
- measure
- Toxicity
- measure
- Quantification of rash after treatment with gefitinib for 1 month and after the addition of PEG-interferon alfa-2a to gefitinib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed primary squamous cell carcinoma of the skin * Metastatic and/or unresectable locally recurrent disease * Measurable disease * No curative treatment option (including resection and radiotherapy) exists or is unacceptably morbid PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Absolute neutrophil count \> 1,500/mm³ * Platelet count \> 100,000/mm³ * Bilirubin \< 1.5 times upper limit of normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV/AIDS allowed * Patients with other cancer diagnoses (e.g., chronic lymphocytic leukemia) are eligible provided disease is controlled and does not require active treatment * No pre-existing medical problems or laboratory abnormalities ≥ grade 3 except renal allograft patients with chronic, stable grade 3-4 renal insufficiency who are dialysis candidates * Nontransplant patients with any degree of renal insufficiency allowed * No serious medical or psychiatric illness that would preclude study compliance * No evidence of severe or uncontrolled (≥ grade 3) systemic disease (e.g., unstable or uncompensated respiratory, cardiac, or hepatic disease) PRIOR CONCURRENT THERAPY: * Prior solid organ transplant allowed * Prior cytotoxic chemotherapy and radiotherapy allowed * More than 30 days since prior experimental cancer treatment * No prior epidermal growth factor receptor-inhibiting drugs, including gefitinib, erlotinib hydrochloride, or cetuximab * No concurrent radiotherapy * No concurrent cytotoxic chemotherapy or other drugs intended to control skin cancer
References
Publications (0)
Data not yet available