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Virus Therapy

Immunotherapy + Cetuximab for Colon Cancer

Phase 1

Recruiting

Led By Maria Morelli

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Has resected stage IV colorectal cancer undergone with curative intent, has completed standard-of-care adjuvant- and/or neo-adjuvant treatment with no evidence of residual disease but has persistent ctDNA in the bloodstream

Has ECOG performance status of 0-1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial will test a new immunotherapy treatment for people with colon cancer who have ctDNA.

Who is the study for?

Adults with high-risk stage II or III colorectal cancer who've finished standard treatment and show no relapse but have ctDNA in their blood, or those with resected stage IV treated with curative intent. Participants must be healthy enough for the trial, not pregnant, without severe allergies to certain antibodies or components of the therapy, free from other cancers within 5 years, and not recently treated with similar drugs.Check my eligibility

What is being tested?

The study tests a combination of immunotherapy using CB-NK cells pre-activated and expanded ex vivo along with cetuximab against minimal residual disease in colon cancer patients. It aims to see if this can target remaining cancer indicated by circulating tumor DNA (ctDNA) after primary treatment.See study design

What are the potential side effects?

Possible side effects include allergic reactions to cetuximab or cell therapy ingredients, infection risks due to immune system changes caused by NK cells and cetuximab, potential organ inflammation from immune responses, as well as general discomfort like fatigue.

Eligibility Criteria

Inclusion Criteria

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

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I had surgery for stage IV colorectal cancer, finished all treatments, have no visible cancer left, but still have cancer DNA in my blood.

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I am fully active or can carry out light work.

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I am 18 years old.

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My blood and organ tests meet the required health standards.

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I have high-risk stage II or III colorectal cancer, finished treatment, no signs of relapse, but still have ctDNA.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 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

The activity of the CB-NK infusion in combination with cetuximab in patients with resected colorectal cancer and positivity for minimal residual disease

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

Respiratory alkalosis

Pneumonia

Microcytic anemia

Pulmonary embolism

Myocardial infarction

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: CetuximabExperimental Treatment4 Interventions

given to patients with high-risk colorectal cancer

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetuximab

2011

Completed Phase 3

~2480

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine phosphate

2007

Completed Phase 2

~360

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,972 Previous Clinical Trials

1,787,302 Total Patients Enrolled

Maria MorelliPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

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

How many participants is the current clinical trial composed of?

"Correct. According to the clinicaltrials.gov listings, this medical study is still recruiting participants since it was first posted on February 28th 2022 and last updated July 23rd 2022. 15 patients are expected to be admitted at a single clinic site for the trial."

Answered by AI

Is this research actively seeking new participants?

"Affirmative. On clinicaltrials.gov, it can be seen that the medical trial began on February 28th 2022 and had its last update on July 23rd 2022. The study is looking to enlist 15 individuals across a single site."

Answered by AI

What primary purpose does Cetuximab serve?

"Cetuximab is a viable therapeutic option for individuals suffering from multiple sclerosis, leukemia, myelocytic diseases, and acute/squamous cell carcinomas."

Answered by AI

Are there any historical precedents of Cetuximab being utilized in medical research?

"As of now, 1007 trials are underway for cetuximab. Of those live studies, 191 have advanced to the third stage. Most experiments occur in Philadelphia but there are 33966 sites running these investigations globally."

Answered by AI

Are there any adverse effects associated with Cetuximab use?

"Our team has assessed Cetuximab to be a 1 on the scale of safety, considering it is in its initial stage of clinical testing and there is limited evidence for both efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A PHASE IB STUDY OF IMMUNOTHERAPY WITH EX VIVO PRE-ACTIVATED AND EXPANDED CB-NK CELLS IN COMBINATION WITH CETUXIMAB, IN COLORECTAL CANCER PATIENTS WITH MINIMAL RESIDUAL DISEASE (MRD)

2022. "A PHASE IB STUDY OF IMMUNOTHERAPY WITH EX VIVO PRE-ACTIVATED AND EXPANDED CB-NK CELLS IN COMBINATION WITH CETUXIMAB, IN COLORECTAL CANCER PATIENTS WITH MINIMAL RESIDUAL DISEASE (MRD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05040568.

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