CLINICAL TRIAL

allogenic GM-CSF plasmid-transfected pancreatic tumor cell vaccine for Cancer of Pancreas

Stage I
Waitlist Available · 18+ · All Sexes · Baltimore, MD

This study is evaluating whether a vaccine made from gene-modified tumor cells can help prevent the recurrence of pancreatic cancer.

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About the trial for Cancer of Pancreas

Eligible Conditions
Pancreatic Neoplasms · Malignant Neoplasm of Pancreas

Treatment Groups

This trial involves 2 different treatments. Allogenic GM-CSF Plasmid-transfected Pancreatic Tumor Cell Vaccine 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
allogenic GM-CSF plasmid-transfected pancreatic tumor cell vaccine
BIOLOGICAL
Experimental Group 2
allogenic GM-CSF plasmid-transfected pancreatic tumor cell vaccine
BIOLOGICAL

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:
Stage I-III disease
Prior surgical resection required
No radiographic evidence of disease recurrence
ECOG performance status 0-1
Hemoglobin ≥ 9 g/dL
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Creatinine ≤ 2.0 mg/dL
Bilirubin ≤ 2.0 mg/dL (unless due to known Gilbert's syndrome)
AST, ALT, and amylase ≤ 2 times upper limit of normal (ULN)
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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: day 0 and day 28 of the each vaccination
Screening: ~3 weeks
Treatment: Varies
Reporting: day 0 and day 28 of the each vaccination
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: day 0 and day 28 of the each vaccination.
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 allogenic GM-CSF plasmid-transfected pancreatic tumor cell vaccine will improve 1 primary outcome and 14 secondary outcomes in patients with Cancer of Pancreas. Measurement will happen over the course of day 0 and day 28 of the each vaccination.

Psychosocial profiles (demographics, quality of life [QOL], hope, social support, decision control) and symptom profile (pain, anorexia, fatigue, mood state) as measured by City of Hope QOL, Cancer Patient/Survivor version
DAY 0 AND DAY 28 OF THE EACH VACCINATION
DAY 0 AND DAY 28 OF THE EACH VACCINATION
Safety as measured by local and systemic toxicities
UNTIL PROGRESSION
Patients continue to receive vaccines until disease progression
UNTIL PROGRESSION
Immune response, in terms of mesothelin, prostate stem cell antigen, and mutated k-ras-specific T-cell responses, as measured by biopsy, histological analysis, and in vitro assays at baseline and at 4 weeks post vaccination
WILL BE COMPUTED FOR EACH PATIENT AT TWO TIME POINTS AROUND EACH VACCINE BOOST: PRE-VACCINATION AND FOUR WEEKS POST VACCINATION
WILL BE COMPUTED FOR EACH PATIENT AT TWO TIME POINTS AROUND EACH VACCINE BOOST: PRE-VACCINATION AND FOUR WEEKS POST VACCINATION
Psychosocial profiles of long-term cancer survivors as measured by the Herth Hope Index at baseline and day 28 of the first vaccination and each semiannual vaccination
BASELINE AND DAY 28 OF THE FIRST VACCINATION AND EACH SEMIANNUAL VACCINATION
BASELINE AND DAY 28 OF THE FIRST VACCINATION AND EACH SEMIANNUAL VACCINATION
Correlation of PK parameters with clinical outcomes
THE RELATIONSHIP BETWEEN PHARMACOKINETIC PARAMETERS AND CLINICAL OUTCOMES WILL BE ASSESSED USING LOGISTIC REGRESSION FOR BINARY OUTCOMES (E.G. TOXICITY) AND COX PROPORTIONAL HAZARDS MODELS FOR TIME TO EVENT OUTCOMES (E.G. OS, PFS).
THE RELATIONSHIP BETWEEN PHARMACOKINETIC PARAMETERS AND CLINICAL OUTCOMES WILL BE ASSESSED USING LOGISTIC REGRESSION FOR BINARY OUTCOMES (E.G. TOXICITY) AND COX PROPORTIONAL HAZARDS MODELS FOR TIME TO EVENT OUTCOMES (E.G. OS, PFS).
Psychosocial profiles of long-term cancer survivors as measured by Pancreatic Cancer Survivor Survey at baseline
BASELINE OF THE FIRST VACCINATION
BASELINE OF THE FIRST VACCINATION
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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 cancer of pancreas?

A person with cancer of pancreatic head can show many different signs. The signs of pancreatic cancer in a person include these: weight loss, weakness, lack of appetite, back and abdominal pain, fever, bloody stool, jaundice, and jaundice combined with elevated alkaline phosphatase.\n

Anonymous Patient Answer

What is cancer of pancreas?

It is the seventh leading cause of death in the USA. About 40,000 people develop it in the USA annually. The age of onset is usually in middle-age (around fifty). Men are affected more frequently than women. Pancreatic adenocarcinoma presents with advanced disease at an advanced stage at diagnosis. There is often jaundice, malnutrition, pain (from metastasis), and bowel obstruction. The 5-year survival rate is 5%. The average age at death is 50 years. Most tumors are well localised. The tumors are often multifocal, and may contain multifocal malignant components. The most useful tools in staging and evaluating the metastatic condition are CT scan, MRI and FDG PET scan.

Anonymous Patient Answer

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

Pancreatic cancer incidence has shown an almost continuous decline in the last 60 years. This decline is unlikely to be due to earlier detection, improved survival, or improved treatments. Rather, this apparent decline may be due to lower risk factors associated with pancreas cancer.

Anonymous Patient Answer

What causes cancer of pancreas?

It is known that several risk factors, such as smoking and occupational exposure, increase the risk of pancreatic cancer. Genetic predisposition is also an important factor in the development of pancreatic cancer. Lifestyle factors do not play a major role in the development of pancreatic cancer. Aspirin and Vitamin E supplements do not appear to protect against pancreatic cancer.

Anonymous Patient Answer

Can cancer of pancreas be cured?

There is no cure for [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer). But, in order to reduce the risk of developing this deadly disease, we should follow the following instructions to prevent cancer. First, we should reduce our smoking habits and stay away from alcohol, sugar, and meat; eat at least 2 or more meals a day; get enough sleep; stay busy, and avoid smoking and drinking too much alcohol. Second, if an early diagnosis of pancreatic cancer does occur, we should go see a pancreas specialist. Third, go to the hospital early, because pancreatic cancer often grows to a big size early on. Finally, when pancreatic cancer has developed a lot, we must consult our pancreas specialist.

Anonymous Patient Answer

What are common treatments for cancer of pancreas?

Surgery is common for most cancers, especially pancreatic duct adenocarcinoma. Chemoradiation is commonly used for unresectable pancreatic cancer. Radiotherapy may be used to treat pancreatic cancer. Targeted therapies may be helpful for patients with advanced pancreatic cancer. The management of cancer of pancreas is similar to other cancers, and is not as well understood as pancreatobiliary cancers.

Anonymous Patient Answer

What is the primary cause of cancer of pancreas?

Results from a recent paper show a major change in the cancer of pancreas during the last decade with incidence increasing by more than five-fold, particularly among men than in other age groups. Pancreatic cancer incidence jumped, with most of this attributable to cancer, of unknown aetiology.

Anonymous Patient Answer

Has allogenic gm-csf plasmid-transfected pancreatic tumor cell vaccine proven to be more effective than a placebo?

Recent findings suggest that the recombinant gm-csf-transfected pancreatic tumor cell vaccine has not led to significant antitumor activities. So it does not seem to be a good therapeutic agent for the pancreatic cancer vaccine.

Anonymous Patient Answer

Have there been other clinical trials involving allogenic gm-csf plasmid-transfected pancreatic tumor cell vaccine?

Findings from a recent study indicate that the PC12-GM-CSF/plasmid can be used as an efficient platform to test the immunogenic and antitumor potential of a number of therapeutic strategies against pancreatic cancer. This represents a novel in vivo preclinical model of pancreatic cancer for development of novel immunogene therapies.

Anonymous Patient Answer

Who should consider clinical trials for cancer of pancreas?

A number of considerations are made before deciding whether a clinical trial is worthwhile. These include type and degree of progression of the untreated cancer, probability of cure and duration of response, overall health status, and any other potential side effects of the therapy.

Anonymous Patient Answer

What are the latest developments in allogenic gm-csf plasmid-transfected pancreatic tumor cell vaccine for therapeutic use?

The pancreatic tumor cells have a potential antitumor vaccination. A safe and effective pancreatic tumor vaccine by allogeneic transfer of the rGMCSF-expressing plasmid DNA is promising. rGMCSF could be a novel, effective, and safe modality for cancer immunotherapy.

Anonymous Patient Answer

What are the chances of developing cancer of pancreas?

Most patients with diabetes develop a type 2 diabetes mellitus. However, about 0.3% developed pancreatic cancer. Diabetes may not be the main cause of pancreatic cancer. [withdurm()].

Anonymous Patient Answer
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