PalloV-CC for Cancer of Colon

Phase-Based Estimates
1
Effectiveness
1
Safety
Clinical Associates of Research Therapeutics of America, San Antonio, TX
Cancer of Colon+1 More
PalloV-CC - Biological
Eligibility
18+
All Sexes
Eligible conditions
Cancer of Colon

Study Summary

This study is evaluating whether vaccination may help improve the immune system's response to cancer.

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Eligible Conditions

  • Cancer of Colon
  • Colonic Neoplasms
  • Malignant Neoplasm of Colon

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether PalloV-CC will improve 4 primary outcomes and 4 secondary outcomes in patients with Cancer of Colon. Measurement will happen over the course of 1 year for all 4 cohorts to enroll and undergo treatment..

Year 1
Primary Immunologic Endpoint-Overall Immunoscore of the tumor microenvironment
Primary Immunologic Endpoint-Per Dosing Cohort Immunoscore of the tumor microenvironment
Primary Safety Endpoint-Overall number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Primary Safety Endpoint-Per Dosing Cohort number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Secondary Endpoint-CD4+ and regulatory T cells expression comparison within the Tumor Microenvironment
Secondary Endpoint-Effect Tumor Microenvironment measured via Immunoscore
Secondary Endpoint-Immunologic comparison of evaluations of tumor microenvironment
Secondary Endpoint-PD-L1 expression comparison within the Tumor Microenvironment

Trial Safety

Safety Estimate

1 of 3

Trial Design

4 Treatment Groups

No Control Group
4x10^8 particles of PalloV-CC

This trial requires 24 total participants across 4 different treatment groups

This trial involves 4 different treatments. PalloV-CC is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

4x10^8 particles of PalloV-CC
Biological
Intradermal injection of PalloV-CC weekly x 4 weekly
2x10^8 particles of PalloV-CC
Biological
Intradermal injection of PalloV-CC weekly x 4 weekly
1x10^8 particles of PalloV-CC
Biological
Intradermal injection of PalloV-CC weekly x 4 weekly
8x10^8 particles of PalloV-CC
Biological
Intradermal injection of PalloV-CC weekly x 4 weekly

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year for all 4 cohorts to enroll and undergo treatment.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for all 4 cohorts to enroll and undergo treatment. for reporting.

Closest Location

Clinical Associates of Research Therapeutics of America - San Antonio, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Stage I-IV (resectable) colon cancer patients identified prior to their definitive surgery
Diagnosis definitively confirmed by endoscopic biopsy with tumor tissue slides available for analysis
Asymptomatic and capable of waiting 4 weeks prior to definitive surgery
ECOG 0-1 performance
Not involved in other clinical trials
Capable of giving informed consent

Patient Q&A Section

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

What causes cancer of colon?

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Adenomas and cancers of colon arise through a mixture of inherited and environmentally-associated factors. Tumors of colon arise most often in people with familial adenomatous polyposis (FAP) due to mutations in the APC gene which affects the DNA mismatch repair machinery. Other mutations in APC also predisposes to developing colon cancer, and APC mutations are present in 2–12% of colorectal tumors. Patients with cancer of colon may have increased levels of serum folate, an important water-soluble vitamin. It can be produced from dietary sources in the body or obtained through ingestion after fortification of folate supplements.

Unverified Answer

How many people get cancer of colon a year in the United States?

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Cancer of colon is a common cause of death in the United States and is likely underreported because most deaths in the United States do not have an obvious cause of death recorded.

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Can cancer of colon be cured?

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The treatment of [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) will improve over time due to medical advances - the cure is achievable in the majority of the cases when the treatment is proper, and even though cancer has the power to affect and kill people, curing can have considerable benefits.

Unverified Answer

What is cancer of colon?

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Cancer of the colon has a very high mortality rate, and the signs and symptoms of colon cancer are nonspecific. Other cancers are more likely to cause symptoms. The causes include infection, inflammatory bowel disease, other cancers, and colon polyps. Colon cancer can be diagnosed by a colonoscopic examination, biopsy, and follow-up endoscopy. The screening for colon cancers by colonoscopy is very effective. There are many screening tests to help help with cancer of the colon but not everyone should do them. If your doctor advises you to undergo a colonoscopy, power can help you find the best screening option.

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What are the signs of cancer of colon?

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A history of smoking is useful as a way of differentiating between squamous and adenocarcinoma of the colon. A family history of cancer is also an important factor given that adenocarcinoma of the colon can result from genetic mutations in people with a family history. Tumours in situ were more common than micro-invasion at presentation; however, the majority of the stage two and higher tumours were micro-invasive by definition.

Unverified Answer

What are common treatments for cancer of colon?

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Most advanced [colon cancer](https://www.withpower.com/clinical-trials/colon-cancer)s are untreated and there are few well-designed trials that have examined various treatment options for such cancers, so current evidence-based treatment recommendations cannot be made. The most common CRC treatment is a combination of surgery, chemotherapy, and radiation, and its effectiveness is limited by associated morbidity and mortality. New options and better-designed clinical trials are needed.

Unverified Answer

How quickly does cancer of colon spread?

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Data from a recent study cancer of colon is a process that can be spread fast. Because of this, we recommend a more cautious approach when we treat patients, because cancer of colon spread at an early stage usually have good results with treatment. The disease spreads as fast as in the last minutes. Because of this we also recommend an early treatment when possible, because it can [quell the spread of cancer] of colon very fast. We think that cancer of colon is a curable disease even if it is spread quickly after the diagnosis.

Unverified Answer

Who should consider clinical trials for cancer of colon?

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Data from a recent study identified the following risk factors for being eligible for CRC clinical trials: history of first-degree relative with CRC, prior CRC diagnosis and clinical evidence of rectal bleeding. Prospective studies should assess the optimal risk selection process in clinical trials for CRC.

Unverified Answer

What is the survival rate for cancer of colon?

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The five-year survival rate of colon cancer (male and female) in Korea is 34%--the lowest of any country in Asia. Although only 30% of patients have a tumor size of<or=10 mm, metastasis occurs in more than half of all colon cancers diagnosed in the US in 2017.

Unverified Answer

How does pallov-cc work?

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The most well-studied pathways mediated by pallopav are the PKCδ pathway that plays a primary role in the induction of apoptosis and the F-actin pathway that is necessary for proliferation and motility. There are two points in the process where cells undergo mitosis: at the G1/S and the M/A checkpoint. For both to be impaired, the F-actin and PKCδ pathways need to be working properly. The PKCδ pathway is activated by phosphorylation. This means that there must be an activating kinase that allows the PKCδ to be activated.

Unverified Answer

Does cancer of colon run in families?

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If this is an inherited trait, then the risk for cancer of colon deserves consideration as possible modifier of colon cancer risk in families with the hereditary syndromes.

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Have there been other clinical trials involving pallov-cc?

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The findings suggest that a controlled human clinical trial evaluating the effects of a biologic or biologics against a control in colorectal cancer patients will yield important information; such that this new drug can be a potentially effective new treatment for this disease.

Unverified Answer
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