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Chemotherapy + Stem Cell Transplant for Pancreatic Cancer
Study Summary
This trial is testing a new treatment for pancreatic cancer in patients with an inherited BRCA1 or BRCA2 mutation. The treatment involves a combination of drugs given through an IV, with the goal of determining if it is safe.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have stage IV pancreatic or breast cancer, even if prior chemotherapy was fully effective.Your disease can be measured or seen on medical tests using specific guidelines.My life expectancy is mainly affected by my cancer, not other diseases.I am able to care for myself but may not be able to do active work.You are expected to live for at least 6 more months.I haven't had chemotherapy in the last 2 weeks.I had chemotherapy for a different cancer within the last year, with a high risk of it coming back.I have a serious heart or blood vessel condition.I have had surgery or ablation to remove my primary tumor.Abnormal test results from lab tests.I have fluid buildup due to cancer in my abdomen or chest.You are expected to live for at least 6 months.I am not willing to consume alcohol.I have a blockage in my bile ducts.I have cholangitis but meet specific treatment conditions.You have signs of sinusoidal obstruction syndrome.My breast cancer is of the type called adenocarcinoma.My cancer has spread to my brain or spinal cord.I have high blood pressure in the veins of my spleen.I have stage IV pancreatic or breast cancer, even if I responded well to previous chemotherapy.I have a BRCA1, BRCA2, or PALB2 gene mutation.I agree to use contraception.My pancreatic cancer is either ductal adenocarcinoma or acinar cell carcinoma.I have a BRCA1, BRCA2, or PALB2 gene mutation.You have a heart condition that makes your heart rhythm last longer than usual on an EKG test.I have very high blood pressure.I have not had a heart attack in the last 6 months.I have high blood pressure in the veins of my liver.My cancer has spread to my heart or eye.I am 18 years old or older.The presence of other medical conditions and reasons not to participate in the study.I have a serious kidney condition.I am either male or female.You have to have a biopsy or other tests to confirm the type of cancer you have.I have a history of lung scarring or damage.Your heart's pumping ability is less than 45%.
- Group 1: Chemotherapy/stem cell treatment
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many people are the researchers hoping to test in this clinical trial?
"Yes, this is an active trial. As the clinicaltrials.gov website indicates, the study was posted on 1/13/2021 and updated on 11/4/2022. They are currently looking for 10 participants at 2 sites."
Who would be most likely to see benefits from participating in this trial?
"Eligibility requirements for this pancreatic cancer study include being between 18 and 70 years old as well as having a specific type of the disease (ductal adenocarcinoma). A maximum of 10 patients can take part in the clinical trial."
What maladies has Autologous Hematopoietic Stem Cells shown to be helpful for?
"Autologous Hematopoietic Stem Cells are most commonly used to address vitamin deficiencies. However, this treatment can also be used for blood disorders like anemia, pernicious anemia, and multiple myeloma."
Are young adults ineligible for this clinical research?
"The age limit for this particular study is 18 to 70. In contrast, there are 85 clinical trials only involving patients under 18 and 1598 studies focused on those over 65 years old."
Are there any current openings for people who want to participate in this trial?
"The information available on clinicaltrials.gov verifies that this study is still recruiting patients. The trial was first announced on January 13th, 2021 and has been updated as recently as November 4th, 2022. They are looking for a total of 10 individuals who will be participating at 2 different locations."
Does the FDA condone Autologous Hematopoietic Stem Cells as a treatment?
"Because this is an early Phase 1 trial, there is only limited data supporting the safety and efficacy of Autologous Hematopoietic Stem Cells."
Are Autologous Hematopoietic Stem Cells a new or innovative treatment?
"City of Hope Comprehensive Cancer Center first studied Autologous Hematopoietic Stem Cells in 1997 and, since then, 622 completed studies exist with 235 clinical trials still active. Many of these ongoing medical studies are based out of New york City."
What goals does this research hope to realize?
"The primary goal of this clinical trial is to assess the rate of delayed engraftment of platelets in patients. Secondary objectives include assessing the objective response rate in metastatic lesions and overall survival. These outcomes will be measured on Day 21 after each treatment, using CT scans with contrast of the abdomen, pelvis, and chest (among other sites as clinically indicated)."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How responsive is this trial?
Most responsive sites:
- Massachusetts General Hospital: < 24 hours
Average response time
- < 1 Day
Typically responds via
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