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Monoclonal Antibodies

Cetuximab + Interleukin-12 for Head and Neck Cancer

Q: What primary aims are being pursued with this clinical investigation?

The main objective of this two-week study is to determine the proportion of patients who achieve a complete or partial response based on Response Evaluation Criteria in Solid Tumors (Phase II). Secondary assessment outcomes encompass Overall Survival (Phase II) determined using Kaplan-Meier method, Induction of Systemic Plasma Levels of Interferon Gamma and Time to Disease Progression (Phase II), also estimated with the help of Kaplan-Meier method.

Q: Are new participants still being admitted to this clinical research project?

This clinical trial, which was first made available on October 26th 2011 and last modified on the 15th of October 2022 is not currently enrolling patients. Fortunately though, there are 3612 other medical studies actively accepting candidates at this moment in time.

Q: What is the overall participant count for this clinical experiment?

At this moment in time, this research endeavour is not enrolling patients. The trial was first made available on October 26th 2011 and most recently updated on the 15th of October 2022. If you're looking for other studies to participate in, there are 3462 trials currently recruiting participants with carcinoma and an additional 150 that require Cetuximab volunteers.

Q: To what ailments does Cetuximab typically provide a remedy?

Cetuximab has been scientifically validated as a viable pharmacological solution for regionally advanced and metastatic <a href="https://www.withpower.com/clinical-trials/squamous-cell-carcinoma">squamous cell carcinoma</a> of the head and neck (hnscc).

Q: Have prior experiments explored the usage of Cetuximab for medical purposes?

Cetuximab was first explored in 2007 at Saint Bartholomew's Hospital, with subsequent studies leading to a total of 982 completed trials. Currently, 150 active investigations are taking place around the world - most notably within Columbus <a href="https://www.withpower.com/clinical-trials/ohio">Ohio</a>.

Phase 1 & 2

Waitlist Available

Led By William E Carson

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have histologically-proven recurrent and/or metastatic squamous cell carcinoma of the head and neck that is unresectable; patients in the phase II portion of the trial must have measurable disease

Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of registration to date of death, assessed up to 1 year

Awards & highlights

Study Summary

This trial is testing the side effects and best dose of a combination of two drugs to treat patients with head and neck squamous cell carcinoma that has come back or spread. The two drugs are recombinant interleukin-12 and cetuximab.

Who is the study for?

This trial is for adults with squamous cell carcinoma of the head and neck that's recurrent, metastatic, or inoperable. They must understand the study and consent to it, have a certain level of physical fitness (ECOG <=2), normal kidney function or specific creatinine clearance, no recent chemotherapy or radiotherapy, not be on other investigational drugs, and have no uncontrolled illnesses. Women who are pregnant or breastfeeding are excluded.Check my eligibility

What is being tested?

The trial is testing how well recombinant interleukin-12 works with cetuximab in treating this type of cancer. It looks at side effects and best doses. Interleukin-12 may boost white blood cells to fight cancer while cetuximab could help the immune system attack cancer cells more effectively.See study design

What are the potential side effects?

Potential side effects include reactions related to stimulating the immune system which can range from flu-like symptoms (fever, fatigue) to more serious conditions affecting organs due to an overactive immune response. Cetuximab can cause skin reactions like acneiform rash and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer in the head or neck area has returned or spread and cannot be removed by surgery.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

My kidney function, measured by creatinine levels, is normal or nearly normal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of registration to date of death, assessed up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of registration to date of death, assessed up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of registration to date of death, assessed up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Dose-limiting Toxicity Incidents to Determine the Maximum Tolerated Dose of IL-12, Evaluated Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I)

Proportion of Patients Who Have Any Response to Treatment (Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors (Phase II)

Secondary outcome measures

Induction of Systemic Plasma Levels of Interferon-gamma

Number of Confirmed Clinical Responses (Phase I)

Overall Survival (Phase II)

+2 more

Side effects data

From 2012 Phase 3 trial • 73 Patients • NCT01177956

43%

Leucopenia

43%

Weight Decreased

40%

Nausea

35%

Rash

34%

Hypomagnesaemia

32%

Hypokalemia

31%

Constipation

28%

Vomiting

28%

Neutropenia

26%

Decreased Appetite

22%

Pyrexia

19%

Acne

19%

Hyponatremia

19%

Hemoglobin Decreased

18%

Stomatitis

18%

Diarrhea

15%

Fatigue

15%

Pruritus

13%

Mucosal Inflammation

13%

Neutrophil Count Decreased

12%

Mouth Ulceration

10%

Insomnia

10%

Thrombocytopenia

10%

Asthenia

Cough

Dizziness

White Blood Cell Count Decreased

Dermatitis Acneiform

Hypocalcaemia

Hypochloremia

Abdominal Pain Upper

Paronychia

Aspartate Aminotransferase Increased

Weight Increased

Dyspnoea

Neck pain

Oral Pain

Headache

Anaphylactic reaction

Pulmonary embolism

Respiratory alkalosis

Microcytic anemia

Myocardial infarction

Pneumonia

Pneumonitis

Electrolyte imbalance

Mouth hemorrhage

Staphylococcal skin infection

Tumor hemorrhage

Toxic encephalopathy

Venous thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase

Cetuximab + Cisplatin + 5-FU : Late Phase

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (cetuximab and recombinant interleukin-12)Experimental Treatment3 Interventions

Patients receive cetuximab IV over 1-2 hours on day 1 and recombinant interleukin-12 SC on days 2 and 5 beginning in course 2. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving clinical response or stable disease may continue with therapy until disease progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetuximab

2011

Completed Phase 3

~2480

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,130 Total Patients Enrolled

William E CarsonPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01468896 — Phase 1 & 2

Head and Neck Squamous Cell Carcinoma Research Study Groups: Treatment (cetuximab and recombinant interleukin-12)

Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT01468896 — Phase 1 & 2

Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01468896 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What primary aims are being pursued with this clinical investigation?

"The main objective of this two-week study is to determine the proportion of patients who achieve a complete or partial response based on Response Evaluation Criteria in Solid Tumors (Phase II). Secondary assessment outcomes encompass Overall Survival (Phase II) determined using Kaplan-Meier method, Induction of Systemic Plasma Levels of Interferon Gamma and Time to Disease Progression (Phase II), also estimated with the help of Kaplan-Meier method."

Answered by AI

Are new participants still being admitted to this clinical research project?

"This clinical trial, which was first made available on October 26th 2011 and last modified on the 15th of October 2022 is not currently enrolling patients. Fortunately though, there are 3612 other medical studies actively accepting candidates at this moment in time."

Answered by AI

What is the overall participant count for this clinical experiment?

"At this moment in time, this research endeavour is not enrolling patients. The trial was first made available on October 26th 2011 and most recently updated on the 15th of October 2022. If you're looking for other studies to participate in, there are 3462 trials currently recruiting participants with carcinoma and an additional 150 that require Cetuximab volunteers."

Answered by AI

To what ailments does Cetuximab typically provide a remedy?

"Cetuximab has been scientifically validated as a viable pharmacological solution for regionally advanced and metastatic squamous cell carcinoma of the head and neck (hnscc)."

Answered by AI

Have prior experiments explored the usage of Cetuximab for medical purposes?

"Cetuximab was first explored in 2007 at Saint Bartholomew's Hospital, with subsequent studies leading to a total of 982 completed trials. Currently, 150 active investigations are taking place around the world - most notably within Columbus Ohio."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cetuximab and Recombinant Interleukin-12 in Treating Patients With Squamous Cell Carcinoma of the Head and Neck That is Recurrent, Metastatic, or Cannot Be Removed by Surgery

2011. "Cetuximab and Recombinant Interleukin-12 in Treating Patients With Squamous Cell Carcinoma of the Head and Neck That is Recurrent, Metastatic, or Cannot Be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01468896.

All > Basal Cell Carcinoma > Squamous Cell Carcinoma