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Monoclonal Antibodies

Cetuximab + Interleukin-12 for Head and Neck Cancer

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%)

Must not have

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Pregnant women are excluded from this study because IL-12 is an agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with IL-12, breastfeeding should be discontinued if the mother is treated with IL-12; these potential risks may also apply to other agents used in this study

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I am not pregnant or breastfeeding.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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%

Hyponatremia

19%

Acne

19%

Hemoglobin Decreased

18%

Stomatitis

18%

Diarrhea

15%

Pruritus

15%

Fatigue

13%

Mucosal Inflammation

13%

Neutrophil Count Decreased

12%

Mouth Ulceration

10%

Insomnia

10%

Thrombocytopenia

10%

Asthenia

Dizziness

Cough

White Blood Cell Count Decreased

Hypocalcaemia

Dermatitis Acneiform

Hypochloremia

Abdominal Pain Upper

Paronychia

Aspartate Aminotransferase Increased

Weight Increased

Dyspnoea

Neck pain

Oral Pain

Headache

Anaphylactic reaction

Microcytic anemia

Mouth hemorrhage

Pneumonia

Electrolyte imbalance

Myocardial infarction

Pneumonitis

Staphylococcal skin infection

Tumor hemorrhage

Pulmonary embolism

Respiratory alkalosis

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 5Eligibility criteria met