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Anti-tumor antibiotic

Cancer Vaccine + Chemotherapy + SBRT for Pancreatic Cancer

N/A
Waitlist Available
Led By Daniel Laheru, M.D.
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented cancer of the pancreas (head, neck, and/or uncinate process), that has been completely resected
No prior Chemotherapy, radiation therapy or biologic therapy for pancreatic cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial is testing a new cancer vaccine in people with pancreatic cancer who have had surgery. The vaccine will be given with two different doses of chemotherapy.

Who is the study for?
This trial is for pancreatic cancer patients who've had surgery to remove the tumor and are within 10 weeks post-operation. They should have a good performance status, no prior cancer treatments, and must agree to use birth control. Exclusions include serious heart, liver or other organ issues, metastatic disease, recent steroids or other therapies, HIV/hepatitis infections, pregnancy/lactation.Check my eligibility
What is being tested?
The study tests a pancreatic tumor cell vaccine (GVAX) with low-dose Cyclophosphamide followed by SBRT radiation and FOLFIRINOX chemotherapy in patients after surgical resection of pancreatic cancer. It aims to estimate the safety of this combination treatment.See study design
What are the potential side effects?
Possible side effects may include immune reactions due to the vaccine, blood count changes from Cyclophosphamide; digestive issues from FOLFIRINOX; skin irritation or fatigue from radiation therapy. Severity can range based on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My pancreatic cancer was surgically removed.
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I have not had chemotherapy, radiation, or biologic therapy for pancreatic cancer.
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I had surgery to remove my cancer less than 10 weeks ago.
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I have at least one titanium clip placed during surgery for treatment planning.
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My organ functions are within normal ranges according to specific tests.
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I will use birth control during and for 28 days after the study.
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I can carry out all my usual activities without help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events as a measure of toxicity
Secondary outcome measures
Survival
Time to disease progression using immune correlates

Side effects data

From 2023 Phase 2 trial • 27 Patients • NCT04002401
88%
Pyrexia
65%
Neutrophil count decreased
62%
Nausea
58%
Hypotension
50%
Anaemia
46%
Headache
38%
Decreased appetite
38%
Fatigue
35%
Confusional state
31%
Diarrhoea
31%
Hypokalaemia
31%
Tachycardia
27%
Back pain
27%
Constipation
27%
Hypophosphataemia
23%
B-cell lymphoma
23%
White blood cell count decreased
23%
Tremor
23%
Platelet count decreased
23%
Dizziness
19%
Agitation
19%
Cough
19%
Hypogammaglobulinaemia
19%
Tachypnoea
19%
Oedema peripheral
19%
Neutropenia
19%
Hyponatraemia
15%
Hypomagnesaemia
15%
Dysphagia
15%
Dyspnoea
15%
Chills
15%
Thrombocytopenia
15%
Alanine aminotransferase increased
15%
Sinus tachycardia
12%
Arthralgia
12%
Aspartate aminotransferase increased
12%
Hypoxia
12%
Myalgia
12%
Malaise
12%
Abdominal pain
12%
Pain
12%
Hypertension
12%
Peripheral sensory neuropathy
12%
Vomiting
12%
Covid-19
12%
Hyperglycaemia
8%
Acute myeloid leukaemia
8%
Aphasia
8%
Pancytopenia
8%
Dysuria
8%
Hyperhidrosis
8%
Lymphocyte count decreased
8%
Gait disturbance
8%
Pneumonia
8%
Sepsis
8%
Oral candidiasis
8%
Muscular weakness
8%
Encephalopathy
8%
Somnolence
8%
Blood creatinine increased
8%
Urinary tract infection
8%
Eye pain
8%
Asthenia
8%
Insomnia
4%
Respiratory failure
4%
Syncope
4%
Depression
4%
Covid-19 pneumonia
4%
Embolism
4%
Pleural effusion
4%
Febrile neutropenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axicabtagene Ciloleucel and Rituximab Combination

Trial Design

2Treatment groups
Experimental Treatment
Group I: SBRT and FOLFIRINOXExperimental Treatment2 Interventions
The first 6 patients will receive SBRT and FOLFIRINOX only.
Group II: Cyclophosphamide, Vaccine, SBRT, and FOLFIRINOXExperimental Treatment4 Interventions
The last 12 patients will receive cyclophosphamide, Vaccine, SBRT, and FOLFIRINOX.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
FOLFIRINOX
2013
Completed Phase 3
~790
Stereotactic Body Radiation (SBRT)
2018
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
554 Previous Clinical Trials
32,892 Total Patients Enrolled
The Skip Viragh FoundationOTHER
3 Previous Clinical Trials
150 Total Patients Enrolled
Daniel Laheru, M.D.Principal InvestigatorThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 Previous Clinical Trials
15 Total Patients Enrolled

Media Library

FOLFIRINOX (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT01595321 — N/A
Pancreatic Cancer Research Study Groups: Cyclophosphamide, Vaccine, SBRT, and FOLFIRINOX, SBRT and FOLFIRINOX
Pancreatic Cancer Clinical Trial 2023: FOLFIRINOX Highlights & Side Effects. Trial Name: NCT01595321 — N/A
FOLFIRINOX (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01595321 — N/A

Frequently Asked Questions

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

What other investigations involving Cyclophosphamide have been conducted thus far?

"Currently, there are 1412 clinical trials for Cyclophosphamide underway. Out of these, 338 have advanced to the third stage of testing. A majority of this research is occurring in Guangzhou, Guangdong; however, investigations into its efficacy span over 51076 locations across the globe."

Answered by AI

Is the age limit for this clinical trial restricted to individuals who are at least 18 years old?

"Prospective patients must meet the following age requirements in order to be included: 18 years or older, and 76 or younger."

Answered by AI

How many participants are actively involved in this clinical trial?

"Unfortunately, at this time there is no recruitment for the trial initially posted on October 29th 2012 and most recently updated March 3rd 2022. However, if you are still searching for studies to join, please be aware that 1353 clinical trials focusing on pancreatic cancer and 1412 research programmes involving cyclophosphamide are actively recruiting participants."

Answered by AI

Are there any open slots presently available for this research trial?

"According to the clinicaltrials.gov website, this particular medical study is no longer recruiting at present. The trial was first announced on October 29th 2012 and last updated March 3rd 2022. While it's not actively looking for new participants presently, there are 2,765 other trials searching for volunteers right now."

Answered by AI

Are there certain eligibility criteria for participating in this research?

"This research is enrolling 19 individuals between 18 and 76 years old that possess a malignancy of the pancreas. Qualifying patients must have undergone surgical removal within 10 weeks, be in an ECOG Performance Status 0 to 1, utilize approved forms of birth control for 28 days post-therapy, comply with study protocol, not had prior Chemotherapy/radiation or biological therapies pertaining to pancreatic cancer, and have titanium clips implanted during surgery for SBRT treatment planning."

Answered by AI

For what general medical purposes is Cyclophosphamide commonly utilized?

"Commonly prescribed to treat small cell lung cancer, cyclophosphamide has also been shown to offer relief from multiple sclerosis, leukemia, myelocytic disorders and various types of carcinoma such as acute and rectal."

Answered by AI
~1 spots leftby Sep 2024