Brief Summary

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.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_2 head-and-neck-cancer

Timeline

Completed

Started Feb 2004

Shorter than P25 for phase_2 head-and-neck-cancer

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.1 years study duration

Study Start

First participant enrolled

February 1, 2004

Completed

1.9 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed

Last Updated

October 31, 2012

Status Verified

October 1, 2012

Enrollment Period

2.1 years

First QC Date

January 12, 2006

Last Update Submit

October 29, 2012

Conditions

Head and Neck Cancer

Keywords

stage II squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the lip and oral cavitystage II squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the oropharynxstage II squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxstage II squamous cell carcinoma of the larynxstage III squamous cell carcinoma of the larynxstage IV squamous cell carcinoma of the larynxrecurrent squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the larynxrecurrent squamous cell carcinoma of the lip and oral cavityrecurrent squamous cell carcinoma of the oropharynx

Outcome Measures

Primary Outcomes (1)

Response rate
3 weeks following treatment

Secondary Outcomes (1)

Toxicity
30 days

Study Arms (4)

Control

ACTIVE COMPARATOR

Control (no treatment), conventional surgery.

Procedure: Conventional surgeryProcedure: Neoadjuvant therapy

PEG-Intron 0.5 mg/kg

EXPERIMENTAL

PEG-interferon alfa-2b 0.5 mg/kg subcutaneously (SQ) once a week for 3 weeks, plus surgery.

Biological: PEG-interferon alfa-2bProcedure: Conventional surgeryProcedure: Neoadjuvant therapy

PEG-Intron 2.5 mg/kg

EXPERIMENTAL

PEG-interferon alfa-2b 2.5 mg/kg SQ once a week for 3 weeks, plus surgery.

Biological: PEG-interferon alfa-2bProcedure: Conventional surgeryProcedure: Neoadjuvant therapy

PEG-Intron 5.0 mg/kg

EXPERIMENTAL

PEG-interferon Alfa-2b 5 mg/kg SQ once a week for 3 weeks, plus surgery.

Biological: PEG-interferon alfa-2bProcedure: Conventional surgeryProcedure: Neoadjuvant therapy

Interventions

PEG-interferon alfa-2bBIOLOGICAL

Study medication begins on Day 1 and taken subcutaneously once each week with the last dose being taken within 1 week prior to surgery or biopsy.

Also known as: SCH 54031

PEG-Intron 0.5 mg/kgPEG-Intron 2.5 mg/kgPEG-Intron 5.0 mg/kg

Conventional surgeryPROCEDURE

Participants on the control arm may undergo surgery at anytime within 3 weeks of randomization, and those randomized to PEG-Intron will undergo surgery on Days 16-22 following initiation of treatment.

ControlPEG-Intron 0.5 mg/kgPEG-Intron 2.5 mg/kgPEG-Intron 5.0 mg/kg

Neoadjuvant therapyPROCEDURE

ControlPEG-Intron 0.5 mg/kgPEG-Intron 2.5 mg/kgPEG-Intron 5.0 mg/kg

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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 radiotherapy

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

Sponsors & Collaborators

M.D. Anderson Cancer Centerlead
National Cancer Institute (NCI)collaborator

Study Sites (1)

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

peginterferon alfa-2bNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Study Officials

Roy S. Herbst, MD, PhD
M.D. Anderson Cancer Center
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 13, 2006

Study Start

February 1, 2004

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

October 31, 2012

Record last verified: 2012-10

Locations

US(1)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (4)

Control

PEG-Intron 0.5 mg/kg

PEG-Intron 2.5 mg/kg

PEG-Intron 5.0 mg/kg

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (4)

Control

PEG-Intron 0.5 mg/kg

PEG-Intron 2.5 mg/kg

PEG-Intron 5.0 mg/kg

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations