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Cancer Vaccine

P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel for Breast Cancer

Phase 1 & 2

Waitlist Available

Led By Issam Makhoul, MD

Research Sponsored by University of Arkansas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the time of definitive surgery (4-8 weeks after chemo); between week 20 and week 23

Awards & highlights

Study Summary

This trial is testing a new cancer vaccine in people with TNBC. The vaccine will be given with standard neoadjuvant chemotherapy (chemo given before surgery). The trial will compare how well the vaccine works when added to standard neoadjuvant chemo to standard neoadjuvant chemo given alone.

Eligible Conditions

Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the time of definitive surgery (4-8 weeks after chemo); between week 20 and week 23

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the time of definitive surgery (4-8 weeks after chemo); between week 20 and week 23

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the time of definitive surgery (4-8 weeks after chemo); between week 20 and week 23 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Demonstration of clinical response

Safety/tolerability

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Chemo+Vaccine ArmExperimental Treatment1 Intervention

Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.

Group II: Control ArmActive Control1 Intervention

Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel

2019

Completed Phase 2

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor

486 Previous Clinical Trials

150,329 Total Patients Enrolled

19 Trials studying Breast Cancer

2,296 Patients Enrolled for Breast Cancer

Issam Makhoul, MDPrincipal InvestigatorUniversity of Arkansas

7 Previous Clinical Trials

217 Total Patients Enrolled

3 Trials studying Breast Cancer

105 Patients Enrolled for Breast Cancer

Sindhu Malapati, MDPrincipal InvestigatorUniversity of Arkansas

1 Previous Clinical Trials

50 Total Patients Enrolled

1 Trials studying Breast Cancer

50 Patients Enrolled for Breast Cancer

Frequently Asked Questions

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

Is enrollment in this clinical experiment open currently?

"The information hosted on clinicaltrials.gov indicates that this medical trial is not currently enrolling patients. The study was initially shared online on the 25th of January 2019 and last edited almost three years later, August 18 2022. Despite being closed to recruitment at present, 4037 other trials are open for enrolment right now."

Answered by AI

Have any other exploratory experiments employed P10s-PADRE alongside MONTANIDE™ ISA 51 VG plus Doxorubicin, Cyclophosphamide, and Paclitaxel?

"Currently, 1686 clinical trials are assessing the efficacy of P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel. Of these studies, 380 have advanced to phase 3. Although most studies for this particular treatment originate from Philadelphia, Pennsylvania there are 68375 active sites across the world that examine its effects."

Answered by AI

What is the maximum number of test subjects allowed to participate in this trial?

"As of now, this study is not currently seeking participants. The trial was first listed on January 25th 2019 and last adjusted August 18th 2022. If you are looking for alternate trials, there are 2351 clinical studies actively recruiting patients with breast cancer, as well as 1686 active studies for P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel."

Answered by AI

Is this clinical trial pioneering in its nature?

"Since 1997, P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel has been investigated in the field of medicine. Alfacell had sponsored its initial trial involving 300 patients back then and it was eventually granted Phase 3 status after meeting all regulatory requirements. Now there are 1686 active trials related to this medication being conducted globally across 81 different nations within 3476 cities."

Answered by AI

What type of ailments can be treated with the combination of P10s-PADRE and MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel?

"P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel is a commonly prescribed treatment for leukemia. This therapy can also be employed to treat advanced non-small cell lung cancer, metastatic bladder cancer, and other types of lung cancers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vaccination of Triple Negative Breast Cancer Patients

2019. "Vaccination of Triple Negative Breast Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02938442.