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Anti-tumor antibiotic

Cyclophosphamide + FOLFIRINOX + GVAX + 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
Adequate organ function as defined by study-specified laboratory tests
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up4 years
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Pancreatic Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
During your surgery, at least one small metal clip made of titanium will be placed to help plan your radiation treatment.

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 2015 Phase 2 trial • 32 Patients • NCT01205503
47%
Anemia
41%
Nausea
31%
Lymphocyte count decreased
28%
Fatigue
28%
White blood cell decreased
28%
Neutrophil count decreased
13%
Platelet count decreased
13%
Headache
13%
Hypoatremia
13%
Constipation
13%
Paresthesia
9%
Cough
9%
Alanine aminotransferase increased
9%
Hypocalcemia
9%
Hypokalemia
9%
Myalgia
9%
Vomiting
9%
Hypoalbuminemia
6%
Dyspnea
6%
Febrile neutropenia
6%
Hypernatremia
6%
Edema Limbs
6%
Mucositis oral
6%
Pain
6%
Chills
6%
Flank Pain
6%
Insomnia
3%
Rash maculo-papular
3%
Urinary Frequency
3%
Vaginal Infection
3%
Diarrhea
3%
Hemorrhoids
3%
Depression
3%
Fibrinogen decreased
3%
Gastritis
3%
Hypomagnesemia
3%
Hypotension
3%
Non-cardiac chest pain
3%
Pain in extremity
3%
Palpitations
3%
Pruritus
3%
Sore Throat
3%
Wheezing
3%
Blurred Vision
3%
MRSA positive infection in toe
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Allergic rhinitis
3%
Anorexia
3%
Lung Infection
3%
Arthralgia
3%
Dermatitis
3%
Creatinine increased
3%
Esophageal Spasms
3%
Hyperglycemia
3%
Lip Infection
3%
Muscle weakness upper limb
100%
80%
60%
40%
20%
0%
Study treatment Arm
Saline
Mesna

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~3790
FOLFIRINOX
2013
Completed Phase 3
~790
Stereotactic Body Radiation (SBRT)
2014
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
549 Previous Clinical Trials
32,801 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 cancerf 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