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Cancer Vaccine
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or 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, which is between week 22 and week 25)
Awards & highlights
Study Summary
This trial is testing a new cancer vaccine in combination with standard neoadjuvant chemotherapy and surgery in patients with early-stage breast cancer.
Eligible Conditions
- Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the time of definitive surgery (4-8 weeks after chemo, which is between week 22 and week 25)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the time of definitive surgery (4-8 weeks after chemo, which is between week 22 and week 25)
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
Identify a feasible schedule of vaccination relative to SoC neoadjuvant chemotherapy when the Chemovax are administered concurrently.
Trial Design
7Treatment groups
Experimental Treatment
Group I: Part 3 - Chemovax Schedule CExperimental Treatment1 Intervention
Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Group II: Part 2 - Chemovax Schedule CExperimental Treatment1 Intervention
Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Group III: Part 1 - Chemovax Schedule EExperimental Treatment1 Intervention
Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).
Group IV: Part 1 - Chemovax Schedule DExperimental Treatment1 Intervention
Feasibility - Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).
Group V: Part 1 - Chemovax Schedule CExperimental Treatment1 Intervention
Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Group VI: Part 1 - Chemovax Schedule BExperimental Treatment1 Intervention
Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Group VII: Part 1 - Chemovax Schedule AExperimental Treatment1 Intervention
Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)
2015
Completed Phase 2
~50
Find a Location
Who is running the clinical trial?
University of ArkansasLead Sponsor
486 Previous Clinical Trials
150,303 Total Patients Enrolled
18 Trials studying Breast Cancer
2,246 Patients Enrolled for Breast Cancer
Issam Makhoul, MDPrincipal InvestigatorUniversity of Arkansas
7 Previous Clinical Trials
191 Total Patients Enrolled
2 Trials studying Breast Cancer
55 Patients Enrolled for Breast Cancer
Sindhu Malapati, MDPrincipal InvestigatorUniversity of Arkansas
1 Previous Clinical Trials
24 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can patients currently sign up for this research project?
"The latest information from clinicaltrials.gov reveals that this study is still seeking patients. The trial was originally posted on 1/14/2015, with the 3/14/2022 update being the most recent one."
Answered by AI
Is this the initial release of research for this topic?
"Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel) has been studied since 1997. The very first trial took place in 1997 and was sponsored by Alfacell. Following the first trial in 1997, which involved 300 patients, Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel) received its"
Answered by AI
What diseases has Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel) shown to be effective in treating?
"The chemotherapy drug regimen known as Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel) is most frequently used to treat kaposi's sarcoma related to AIDS. However, it can also be employed in the treatment of leukemia, locally advanced non-small cell lung cancer, and metastatic bladder cancer."
Answered by AI
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