CLINICAL TRIAL

Comprehensive Ablative Radiation Therapy for Carcinoma, Merkel Cell

Metastatic
Stage III
Recruiting · 18+ · All Sexes · Montvale, NJ

This study is evaluating whether a combination of radiation and a drug may help treat Merkel cell carcinoma.

See full description

About the trial for Carcinoma, Merkel Cell

Eligible Conditions
Neuroendocrine Carcinoma of the Skin · Carcinoma, Merkel Cell · Carcinoma

Treatment Groups

This trial involves 2 different treatments. Comprehensive Ablative Radiation Therapy is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Comprehensive Ablative Radiation Therapy
RADIATION
+
Avelumab
DRUG
Experimental Group 2
Comprehensive Ablative Radiation Therapy
RADIATION

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
A biopsy has confirmed that the person has Merkel cell carcinoma, a type of cancer that is difficult to treat and has spread to other parts of the body show original
prior to disease progression People who have previously been treated with aPD1 monotherapy and have seen their disease progress for at least 10 weeks after starting treatment, unless they experience significant clinical deterioration before their disease progressed, are not eligible for this study. show original
for enrolment Patients who have progression in only one of several metastases will not be eligible for enrolment. show original
Able to understand information provided The patient is able to understand information about the study and provide written informed consent. show original
, hematocrit ≥27%, and reticulocyte count ≥1.5% The patient has a normal blood count. show original
Karnofsky Performance Status ≥80% Eastern Cooperative Oncology Group (ECOG) 0-1 Adequate hematologic, hepatic, and renal function A treating physician and principal investigator will determine when a patient's clinical status has deteriorated enough to stop treatment show original
The patient has no evidence of metastatic disease and bilirubin, AST, and ALT are all within normal limits. show original
(ECOG PS) The person has a very poor performance status and is unable to carry out daily activities. show original
If a patient's condition worsens while they are taking aPD1 monotherapy, they are eligible for the study ≥6 weeks after starting the therapy. show original
Every day, our organs and marrow work hard to keep us healthy show original
View All
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
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: at 12 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: at 12 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: at 12 weeks.
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 Comprehensive Ablative Radiation Therapy will improve 1 primary outcome and 1 secondary outcome in patients with Carcinoma, Merkel Cell. Measurement will happen over the course of up to 12 weeks.

overall response rate
UP TO 12 WEEKS
measured by RECIST 1.1
UP TO 12 WEEKS
progression free survival
AT 12 WEEKS
measured by RECIST 1.1
AT 12 WEEKS

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 common treatments for carcinoma, merkel cell?

A variety of therapies have been used at various times in the past. Survival is better in MM and MCL than in other carcinomas. Chemotherapy is useful for MM and MCL in certain types. The exact role of radiation therapy in MM and MCL needs further study, especially in MCL on a large scale with long-term follow-up.

Anonymous Patient Answer

What are the signs of carcinoma, merkel cell?

Some signs include painless, slow onset bleeding gums or gums that are bright red, the sensation of teeth brushing is unpleasant, and gums which have a whitish, yellowish-orange or pinkish-red base, with a yellow, brown or black middle.\n\nFor patients with signs of cancer, medical practitioners should take a family history of any form of cancer, including those of the digestive tract and the urinary system.\n\nTests for signs of cancer includes physical examination as well as an x-ray test, PET scan, CT scan, MRI scan, and endoscopy.

Anonymous Patient Answer

Can carcinoma, merkel cell be cured?

Patients with carcinoma, merkel cell of the adrenal gland should be considered a group of patients needing well-planned follow-up and surveillance as the disease evolves, as carcinoma, merkel cell of the adrenal gland is highly aggressive and usually disseminates early to lymph nodes.

Anonymous Patient Answer

What is carcinoma, merkel cell?

MCC is a type of non-Hodgkin's lymphoma that often arises in the head and neck region and has an excellent long-term outcome. It is a unique lymphoma, because, in contrast to many other types of non-Hodgkin lymphomas, it is almost exclusively associated with mutations in the "KIT" gene.

Anonymous Patient Answer

What causes carcinoma, merkel cell?

MCC is rare. Previous exposure to ionizing radiation is a very strong risk factor. Chemotherapy, smoking, and other environmental (genetic and lifestyle, nutritional) effects appear to be less important or have not been studied adequately in the literature. Other factors, such as a family history of MCC is unknown or unclear. These factors cannot be tested definitively for MCC. Many of the hypotheses can be challenged by future research.

Anonymous Patient Answer

How many people get carcinoma, merkel cell a year in the United States?

About 8.0 million people in the United States are admitted for treatment of merkel cell carcinoma and 1140 patients will develop merkel cell carcinoma each year. Merkel cell carcinoma is the second most common primary site of metastasis in patients with multiple myeloma after multiple myeloma. Patients suffering from multiple myeloma have an increased risk of developing systemic disease in the form of carcinoma, merkel cell carcinoma.

Anonymous Patient Answer

What is the average age someone gets carcinoma, merkel cell?

This finding is in agreement with a large body of literature and the consensus among many experts that most (70%) carcinomas arise from a small group of precursor lesions referred to as field changes. Clinically, most merkel-cell carcinomas do not develop until after the second decade of life is achieved. A subset of carcinomas, approximately 10% to 15%, occur in the first decade of life and represent the most aggressive types. These children are likely to develop lymph node and distant metastases, with more frequent local recurrences and late distant relapses than adolescents and young adults. To prevent this, we must focus efforts on prevention in infancy through maternal immunization and vaccination of children younger than 3 years.

Anonymous Patient Answer

Is comprehensive ablative radiation therapy typically used in combination with any other treatments?

For the purposes of treatment planning and determination of disease control using ablative RT alone, the standard practice of combining ablative RT with other modalities without any clinical evidence should be abolished.

Anonymous Patient Answer

What are the latest developments in comprehensive ablative radiation therapy for therapeutic use?

The last 20 years have seen a dramatic increase in treatment options for localized malignancies. These advances were driven by improvements in imaging and radiation physics technology, and a greater understanding of the molecular underpinnings of disease. Many of these advances have expanded treatment opportunities for patients with stage I-III squamous cell carcinoma of the head and neck. The development of brachytherapy has revolutionized the treatment of head and neck cancer, providing durable control of disease in over 90% of patients and in many cases preserving the facial and oral structures.

Anonymous Patient Answer

Have there been other clinical trials involving comprehensive ablative radiation therapy?

There are few contemporary clinical trials that use the ABIRIT techniques that produce a complete response. As such, the data on [LRR, disease-free survival, and distant metastasis-free survival] may be too [unclear] to allow an accurate prediction of the outcome of one's treatment. One trial was published after the second article had been submitted for this project. As a result, we cannot determine whether ABIRIT is better than traditional RT-RT in [LRR], DFS, or DMFS. ABIRIT techniques may be [effective] in the future. However, we know that many people receive conventional RT as standard of care.

Anonymous Patient Answer

Does comprehensive ablative radiation therapy improve quality of life for those with carcinoma, merkel cell?

Comprehensive ablative radiation therapy for malignant tumors of the scalp and face may produce good long-term disease control with better quality of life than a less intense initial radiotherapy approach or no RT.

Anonymous Patient Answer

Does carcinoma, merkel cell run in families?

The occurrence of carcinoma in a first degree relative within the last 20 generations is a rare finding in most populations. It is not so rare in Japan that it warrants consideration as a hereditary tumour. The possible mechanism by which this occurrence of MCC could result from a genetic mutation, rather than environmental influences, remains speculative.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Carcinoma, Merkel Cell by sharing your contact details with the study coordinator.