CLINICAL TRIAL

Copper Cu 64 Anti-CEA Monoclonal Antibody M5A for Locally Advanced Rectal Carcinoma

Locally Advanced
Waitlist Available · 18+ · All Sexes · Duarte, CA

An Investigational Scan (64Cu-Labeled M5A Antibody) in Combination With SOC Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer

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About the trial for Locally Advanced Rectal Carcinoma

Eligible Conditions
Locally Advanced Rectal Carcinoma · Stage IIIC Rectal Cancer AJCC v8 · Stage III Rectal Cancer AJCC v8 · Rectal Neoplasms · Stage IIIA Rectal Cancer AJCC v8 · Stage IIIB Rectal Cancer AJCC v8

Treatment Groups

This trial involves 2 different treatments. Copper Cu 64 Anti-CEA Monoclonal Antibody M5A is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Copper Cu 64 Anti-CEA Monoclonal Antibody M5A
BIOLOGICAL
Imaging Technique
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients must have histologically confirmed CEA expressing locally advanced rectal cancer (T3, T4 and N0 or N plus [+])
Patients must have a known site of disease. show original
Patients must be at least 18 years of age. show original
The effects of 64Cu-M5A on the developing fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence} prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
You are planned for neoadjuvant therapy with CRT. show original
Although not mandated by the protocol, the results of the computed tomography (CT), magnetic resonance imaging (MRI) and fludeoxyglucose F-18 (FDG) PET scans and labs (blood cell count [CBC], comprehensive metabolic panel [CMP]) that are performed as part of the standard work up should be available and should have been done within 2 months prior to study entry
You have the ability to understand and the willingness to sign a written informed consent. show original
Prior therapy (chemotherapy, immunotherapy, radiotherapy) must be completed at least 2 weeks prior to infusion of radiolabeled antibody
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 3 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 3 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Copper Cu 64 Anti-CEA Monoclonal Antibody M5A will improve 1 primary outcome and 1 secondary outcome in patients with Locally Advanced Rectal Carcinoma. Measurement will happen over the course of Up to 3 years.

Number of patients with impactful finding using 64Cu-M5A positron emission tomography (PET) imaging.
UP TO 3 YEARS
We seek to evaluate the potential for 64Cu-M5A PET imaging in locally advanced rectal cancer before and after neoadjuvant radio-chemotherapy yet prior to planned surgery. Scan findings will be compared to standard of care imaging studies (eg. CT, MRI and FDG PET scans) and biopsy and findings from endoscopy and surgery performed post neoadjuvant CRT therapy. Each of the 15 cases will be reviewed in a protocol team meeting consisting of a radiologist, radiation oncologist, surgeon and pathologist. Cases will be determined by consensus. Examples of "potentially impactful" would be 1) any new lesion not seen on other imaging modalities and confirmed by pathology, 2) a negative 64CuM5A PET on a suspicious lesion by standard of care (SOC) determined to be negative on pathology, or 3) other important differences as judged by the evaluation team including if findings from initial 64CuDOTA-M5A immunoPET imaging could result in modification and adaption of the radiotherapy plan.
UP TO 3 YEARS
Count of Adverse Events.
UP TO 3 YEARS
The frequency and severity of any adverse events possibly related to 64Cu-M5A PET. The toxicity will be graded using the NCI common toxicity scale CTCAE v 5.
UP TO 3 YEARS

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 are the signs of locally advanced rectal carcinoma?

Painless masses, and anemia and anemia-hemoglobin drop have been recognized as characteristic features. There may be local or distant spread. A mass in the rectum can be the first presenting symptom and there may be delay in diagnosis or treatment. The most likely underlying cause is malignant, but inflammatory intestinal disease can produce similar appearances. It may take a long time to achieve the correct histopathologic diagnosis. The management depends on the extent and localization of the disease. Surgery in local disease is an option. Surgery is contraindicated in advanced disease as it is often ineffectively managed nonoperatively. Patients with locally advanced rectal cancer who do not undergo surgery may be offered concurrent chemoradiotherapy.

Anonymous Patient Answer

Can locally advanced rectal carcinoma be cured?

The survival in locally advanced rectal carcinoma, if treated with abdominoperineal resection, is relatively good but still is a dismal 1 year survival. A 5-year survival of 50% and a 10-year survival of 14% indicates that a large percentage of patients with locally advanced rectal carcinoma do not receive an appropriate systemic adjuvant treatment. A further analysis revealed that age at presentation affects the 10-year survival rate, with a trend towards a better prognosis in the older patients.

Anonymous Patient Answer

How many people get locally advanced rectal carcinoma a year in the United States?

The most prevalent form of locally advanced RC patients in the US are between 20 and 40 years of age and female. Although most RC patients who undergo preoperative chemoradiation will have acceptable prognoses in terms of long-term survival, the number of unnecessary RC patients that die will increase if this treatment and the number of people having locally advanced RC is not managed appropriately.

Anonymous Patient Answer

What causes locally advanced rectal carcinoma?

There are many causes for locally advanced rectal carcinoma, but their combined effects cause rectal carcinoma with the features cited above with a high accuracy in predicting the cause of the lesion.

Anonymous Patient Answer

What is locally advanced rectal carcinoma?

local pelvic and abdomino-perineal diseases due to local invasion of rectal cancer were rare in our series with the use of modern imaging techniques. However, lymph node infiltration is the most common cause of recurrent disease. Modern imaging is useful to evaluate the local extent of invasive carcinomas but should be interpreted cautiously when performing staging procedures for loco-regional disease, as the clinical significance has not been evaluated by prospective trials.

Anonymous Patient Answer

What are common treatments for locally advanced rectal carcinoma?

Radiotherapy is the most important treatment for rectal carcinoma, followed by CT as local treatment and preoperative radiotherapy, whereas neoadjuvant combination chemotherapy is a novel adjuvant treatment option. These approaches can be combined with either local surgical treatment, local radiation therapy, or intra-arterial or embolisation of the tumour.

Anonymous Patient Answer

Does locally advanced rectal carcinoma run in families?

A significant percentage of familial rectal cancer presents with locally advanced disease, as determined by a local stage of disease. Although the reasons for this are unknown, an aggressive approach, not just surgery and radiotherapy but also chemotherapy should be explored before the potential deleterious effect of chemotherapy on local tumor control is considered.

Anonymous Patient Answer

Has copper cu 64 anti-cea monoclonal antibody m5a proven to be more effective than a placebo?

• • The m5a was found to be active as a cancer therapy against LARC in a recent study in Japan. But the authors found a higher therapeutic response in the placebo group, than the anti-CEa group (p<0.01), especially at 5 weeks. • • • A higher dosage than that used in the first study might be required for the treatment effect.

Anonymous Patient Answer

Who should consider clinical trials for locally advanced rectal carcinoma?

Clinical trials do not appear to be worthwhile for locoregional therapies of LARCs. We must reconsider our own patients with these locally advanced and metastatic/recurrent cancers.

Anonymous Patient Answer

What is the survival rate for locally advanced rectal carcinoma?

Although there have been a number of well-designed trials for patients with pT3 rectal cancer, there are still a number of patients with locally advanced rectal carcinoma who have low survival rates. Although local radiation therapy decreases the stage after surgery and improves the survival rate, adjuvant treatment with preoperative chemotherapy is still recommended.

Anonymous Patient Answer

What is the average age someone gets locally advanced rectal carcinoma?

Results from a recent paper reveals that on average men with LARC receive a lower age at diagnosis of cancer than women, probably because of the lower use of routine colonoscopy among men in developed countries. Women, moreover, have more advanced disease at diagnosis. This means that, in a developed country, the most likely ages for men and women to have LARC have changed.

Anonymous Patient Answer

How serious can locally advanced rectal carcinoma be?

In this cohort, T3 [rectal cancer](https://www.withpower.com/clinical-trials/rectal-cancer) was associated with a slightly higher survival rate than T1-T2 cancers. In the T3 group, survival was independently influenced by lymph node and distant metastasis. To our knowledge, this is the largest series to report on the prognostic utility of this classification of rectal cancer.

Anonymous Patient Answer
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