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Anti-tumor antibiotic

Cyclophosphamide + FOLFIRINOX + GVAX + SBRT for Pancreatic Cancer

Q: For what general medical purposes is Cyclophosphamide commonly utilized?

<p>Commonly prescribed to treat <a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a>, cyclophosphamide has also been shown to offer relief from <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a>, <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, myelocytic disorders and various types of carcinoma such as acute and rectal.</p>

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

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

Cough

Alanine aminotransferase increased

Hypocalcemia

Hypokalemia

Myalgia

Vomiting

Hypoalbuminemia

Dyspnea

Febrile neutropenia

Hypernatremia

Edema Limbs

Mucositis oral

Pain

Chills

Flank Pain

Insomnia

Rash maculo-papular

Urinary Frequency

Vaginal Infection

Diarrhea

Hemorrhoids

Depression

Fibrinogen decreased

Gastritis

Hypomagnesemia

Hypotension

Non-cardiac chest pain

Pain in extremity

Palpitations

Pruritus

Sore Throat

Wheezing

Blurred Vision

MRSA positive infection in toe

Alkaline phosphatase increased

Blood bilirubin increased

Allergic rhinitis

Anorexia

Lung Infection

Arthralgia

Dermatitis

Creatinine increased

Esophageal Spasms

Hyperglycemia

Lip Infection

Muscle weakness upper limb

100%

80%

60%

40%

20%

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

0 / 3Eligibility criteria met

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 cancer f 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

Recent research and studies

clinicaltrials.govStudy

Pancreatic Tumor Cell Vaccine (GVAX), Low Dose Cyclophosphamide, Fractionated Stereotactic Body Radiation Therapy (SBRT), and FOLFIRINOX Chemotherapy in Patients With Resected Adenocarcinoma of the Pancreas

2012. "Pancreatic Tumor Cell Vaccine (GVAX), Low Dose Cyclophosphamide, Fractionated Stereotactic Body Radiation Therapy (SBRT), and FOLFIRINOX Chemotherapy in Patients With Resected Adenocarcinoma of the Pancreas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01595321.

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