Clinical trial · Interventional
PEG-interferon Alfa-2b in Treating Patients With Stage II, Stage III, or Stage IV Head and Neck Cancer That Can Be Removed By Surgery
A Randomized Phase II Study of SCH 54031 in Surgically Resectable Squamous Cell Tumors of the Head and Neck
- 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: SCH 54031 (PEG-interferon alfa-2b) may interfere with the growth of tumor cells and slow the growth of head and neck cancer. It may also stop the growth of head and neck cancer by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This randomized phase II trial is studying how well different doses of PEG-interferon alfa-2b work in treating patients with stage II, stage III, or stage IV head and neck cancer that can be removed by surgery.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional surgery | Procedure | — | UNRESOLVED |
| Neoadjuvant therapy | Procedure | — | UNRESOLVED |
| PEG-interferon alfa-2b | Biological | Peginterferon Alfa-2b | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Control (no treatment), conventional surgery.
- interventionNames
- Procedure: Conventional surgery
- Procedure: Neoadjuvant therapy
- type
- EXPERIMENTAL
- label
- PEG-Intron 0.5 mg/kg
- description
- PEG-interferon alfa-2b 0.5 mg/kg subcutaneously (SQ) once a week for 3 weeks, plus surgery.
- interventionNames
- Biological: PEG-interferon alfa-2b
- Procedure: Conventional surgery
- Procedure: Neoadjuvant therapy
- type
- EXPERIMENTAL
- label
- PEG-Intron 2.5 mg/kg
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed squamous cell carcinoma of the head and neck
* Stage II, III, or IV disease
* One of the following primary tumor sites:
* Oral cavity
* Oropharynx
* Hypopharynx
* Larynx
* Resectable disease
* Scheduled to undergo surgery as primary treatment
* Distant metastases or a second primary tumor allowed provided tumor deemed resectable by the surgeon
* No squamous cell carcinoma of the nasopharynx or skin
PATIENT CHARACTERISTICS:
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* White Blood Cells (WBC) \> 3,000/mm\^3
* Platelet count ≥ 150,000/mm\^3
* Hemoglobin ≥ 10 g/dL
* Transfusion and/or epoetin alfa support allowed provided it is given ≥ 1 week before study entry AND the patient is stable
* Bilirubin \< 1.5 times upper limit of normal (ULN)
* serum glutamic pyruvic transaminase (SGPT) ≤ 5 times ULN
* Creatinine \< 1.5 times ULN
* No hemolytic anemia
* No hemoglobinopathies (e.g., thalassemia)
* No prior or current ascites
* No bleeding varices
* No other evidence of decompensated liver disease
* No symptomatic ischemic heart disease
* No symptomatic congestive heart failure
* No other uncontrolled heart condition
* No chronic obstructive pulmonary disease
* No documented pulmonary hypertension
* No other chronic pulmonary disease
* No known HIV positivity
* No AIDS-related illness
* No active uncontrolled infection
* No immunologically mediated disease, including any of the following:
* Inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
* Rheumatoid arthritis
* Idiopathic thrombocytopenia purpura
* Systemic lupus erythematosus
* Autoimmune hemolytic anemia
* Scleroderma
* Severe psoriasis
* No Central Nervous System (CNS) trauma
* No confusion or disorientation
* No active seizure disorders requiring medication
* No spontaneous encephalopathy
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No pre-existing uncontrolled thyroid abnormality
* No poorly controlled diabetes mellitus
* No history of major psychiatric illness that would prelude giving informed consent
* No nonmalignant systemic disease that would preclude study participation
PRIOR CONCURRENT THERAPY:
* More than 4 weeks since prior biologic therapy and recovered
* More than 4 weeks since prior chemotherapy and recovered
* More than 4 weeks since prior radiotherapy and recovered
* More than 4 weeks since prior surgery
* No prior interferon
* No other concurrent immunotherapy
* No concurrent chemotherapy
* No concurrent hormonal antineoplastic therapy
* No concurrent systemic corticosteroids
* No concurrent radiotherapyReferences
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