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Cancer Vaccine

Dendritic Cell Vaccine for Sarcoma

Q: Could you please detail the other experiments conducted using Dendritic Cells Vaccines?

Presently, 466 Dendritic Cells <a href="https://www.withpower.com/clinical-trials/vaccine">Vaccine</a> trials are in progress with 139 of them being within the Phase 3 stage. Houston is a hub for such studies; however, there are 24,637 sites worldwide hosting research on this form of vaccination therapy.

Q: Does the age requirement for this clinical trial exceed 25 years?

According to the study's enrollment rules, those who qualify must be aged between one and a hundred years old. There are 187 trials for minors younger than 18, and 813 studies targeting people over 65.

Q: To what diseases are Dendritic Cells Vaccines commonly administered?

Dendritic Cells <a href="https://www.withpower.com/clinical-trials/vaccine">Vaccine</a> has been shown to effectively treat small cell lung carcinoma, <a href="https://www.withpower.com/clinical-trials/head-and-neck-cancer">head and neck cancer</a>, as well as locally advanced pancreatic adenocarcinoma.

Q: Has Dendritic Cell Vaccine been granted regulatory clearance by the FDA?

Considering the limited data on safety and efficacy, our team has rated Dendritic Cells <a href="https://www.withpower.com/clinical-trials/vaccine">Vaccine</a> a 1 in terms of overall risk.

Q: Do I meet the criteria for participation in this research project?

This clinical trial is seeking 19 people aged 1 to 100 years old, diagnosed with sarcoma. Subjects must have histologically or cytologically confirmed <a href="https://www.withpower.com/clinical-trials/soft-tissue-sarcoma">soft tissue sarcoma</a> that can be excised and used for lysate creation; bone-only lesions are ineligible. Applicants should not have received radiotherapy of chemotherapy within the past 4 weeks, nor any corticosteroids, antihistamines, or salicylates in the week prior to first vaccination. Brachytherapy catheters may be placed if removable but implanted seeds are disallowed; external beam radiation therapy may start after DC vaccinations and complete before lysate

Q: Are there vacancies available for individuals to participate in this clinical trial?

Unfortunately, clinicaltrials.gov does not list this trial as actively recruiting patients at present; the investigation was first made public on January 6th 2014 and its last update occurred on July 18th 2022. Nonetheless, there are currently 910 other studies in search of volunteers.

Q: To what extent is the participant pool for this medical trial growing?

This particular trial is not presently searching for volunteers. According to the clinicaltrials.gov record, it was first posted on June 1st 2014 and last amended July 18th 2022. For those seeking alternative studies, there are 444 medical trials actively enrolling <a href="https://www.withpower.com/clinical-trials/sarcoma">sarcoma</a> patients and 466 Dendritic Cells <a href="https://www.withpower.com/clinical-trials/vaccine">Vaccine</a> investigations that need participants.

Phase 1

Waitlist Available

Led By Gina D'Amato, MD

Research Sponsored by Macarena De La Fuente, MD

Eligibility Criteria Checklist

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

Must have

Adequate organ function: Absolute neutrophil count (ANC) ≥ 0.75* 10^3/µL, Lymphocytes ≥ 0.5 * 10^3/µL, Platelets ≥ 75 * 10^3/µL, Hemoglobin ≥ 9 g/dL, Aspartate aminotransferase (AST)/Alanine transaminase (ALT) ≤ 2.5 X upper limit of normal (ULN); if liver metastases, ≤ 5 X ULN, Serum Creatinine ≤ 1.5 X ULN, Total Bilirubin ≤ 3 X ULN, Albumin > 2 g/dL, Karnofsky/Lansky score of ≥ 70% or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, Subjects must agree to use adequate method of contraception or abstinence throughout and up to 4 weeks after the study treatment completion, Life expectancy of > 3 months, Written consent by patient or parent(s) (if patient is < 18 years) on an institutional review board (IRB)-approved informed consent form prior to any study-specific evaluation. Assent is required from children as per University of Miami (UM) IRB guidelines. Subject must be capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years post-treatment

Awards & highlights

Study Summary

This trial is testing a new vaccine made from patients' own cells and tumor to fight sarcoma.

Who is the study for?

This trial is for children and adults aged 1-100 with sarcoma, who haven't had corticosteroids, antihistamines or salicylates a week before vaccination. They must have good organ function and no recent chemo or radiotherapy. Participants need to understand the study's risks, agree to use contraception, and not be pregnant or breastfeeding. Those with brain metastases stable for three months may join.Check my eligibility

What is being tested?

The trial tests a dendritic cell vaccine made from patients' own cells combined with their tumor material against sarcoma. It includes leukapheresis (a procedure to collect white blood cells), gemcitabine (chemotherapy), imiquimod (an immune response modifier), and lysate of tumor as part of the treatment process.See study design

What are the potential side effects?

Potential side effects include reactions at the injection site, flu-like symptoms such as fever and fatigue, allergic responses due to components in the vaccine or chemotherapy drugs like gemcitabine, lowered blood counts leading to increased infection risk, and possible autoimmune reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post-treatment 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 Safety and Tolerability

Secondary outcome measures

Measurement levels of Myeloid Derived Supressor Cells after Gemcitabine treatment

Therapeutic procedure

Overall Survival

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Part 1-DC Vaccine/LysateExperimental Treatment4 Interventions

Leukapheresis: Baseline, post-surgery; Dendritic Cells Vaccine (DC Vaccine): Post-Leukapheresis, administered once weekly in dose-escalation scheme for 4 weeks; Lysate of Tumor (Lysate): Post-DC Vaccine therapy, administered during weeks 8, 12, 16 and 20; Imiquimod: Self-applied topically by subject before and after scheduled DC Vaccine or Lysate administrations.

Group II: Part 2-Gemcitabine/DC Vaccine/LysateActive Control5 Interventions

Leukapheresis: Baseline, post-surgery; Gemcitabine: Post-Leukapheresis, administered once weekly for 3 weeks; Dendritic Cells Vaccine (DC Vaccine): Post-Gemcitabine therapy, Recommended Phase 2 Dose (RP2D) administered once weekly for 4 weeks; Lysate of Tumor (Lysate): Post-DC Vaccine therapy, administered during weeks 12, 16, 20 and 32; Imiquimod: Self-applied topically by subject before and after scheduled DC Vaccine or Lysate administrations.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Imiquimod

2005

Completed Phase 4

~2260

Leukapheresis

2016

Completed Phase 2

~690

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Macarena De La Fuente, MDLead Sponsor

1 Previous Clinical Trials

20 Total Patients Enrolled

Gina D'Amato, MDPrincipal InvestigatorUniversity of Miami

1 Previous Clinical Trials

22 Total Patients Enrolled

1 Trials studying Sarcoma

22 Patients Enrolled for Sarcoma

Media Library

Dendritic Cells Vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT01803152 — Phase 1

Sarcoma Research Study Groups: Part 1-DC Vaccine/Lysate, Part 2-Gemcitabine/DC Vaccine/Lysate

Sarcoma Clinical Trial 2023: Dendritic Cells Vaccine Highlights & Side Effects. Trial Name: NCT01803152 — Phase 1

Dendritic Cells Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01803152 — Phase 1

Frequently Asked Questions

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

Could you please detail the other experiments conducted using Dendritic Cells Vaccines?

"Presently, 466 Dendritic Cells Vaccine trials are in progress with 139 of them being within the Phase 3 stage. Houston is a hub for such studies; however, there are 24,637 sites worldwide hosting research on this form of vaccination therapy."

Answered by AI

Does the age requirement for this clinical trial exceed 25 years?

"According to the study's enrollment rules, those who qualify must be aged between one and a hundred years old. There are 187 trials for minors younger than 18, and 813 studies targeting people over 65."

Answered by AI

To what diseases are Dendritic Cells Vaccines commonly administered?

"Dendritic Cells Vaccine has been shown to effectively treat small cell lung carcinoma, head and neck cancer, as well as locally advanced pancreatic adenocarcinoma."

Answered by AI

Has Dendritic Cell Vaccine been granted regulatory clearance by the FDA?

"Considering the limited data on safety and efficacy, our team has rated Dendritic Cells Vaccine a 1 in terms of overall risk."

Answered by AI

Do I meet the criteria for participation in this research project?

"This clinical trial is seeking 19 people aged 1 to 100 years old, diagnosed with sarcoma. Subjects must have histologically or cytologically confirmed soft tissue sarcoma that can be excised and used for lysate creation; bone-only lesions are ineligible. Applicants should not have received radiotherapy of chemotherapy within the past 4 weeks, nor any corticosteroids, antihistamines, or salicylates in the week prior to first vaccination. Brachytherapy catheters may be placed if removable but implanted seeds are disallowed; external beam radiation therapy may start after DC vaccinations and complete before lysate"

Answered by AI

Are there vacancies available for individuals to participate in this clinical trial?

"Unfortunately, clinicaltrials.gov does not list this trial as actively recruiting patients at present; the investigation was first made public on January 6th 2014 and its last update occurred on July 18th 2022. Nonetheless, there are currently 910 other studies in search of volunteers."

Answered by AI

To what extent is the participant pool for this medical trial growing?

"This particular trial is not presently searching for volunteers. According to the clinicaltrials.gov record, it was first posted on June 1st 2014 and last amended July 18th 2022. For those seeking alternative studies, there are 444 medical trials actively enrolling sarcoma patients and 466 Dendritic Cells Vaccine investigations that need participants."

Answered by AI

Recent research and studies

Clinical Cancer ResearchJournal

Neoadjuvant Therapy Induces a Potent Immune Response to Sarcoma, Dominated by Myeloid and B Cells

Goff, Peter H., Laura Riolobos, Bonnie J. LaFleur, Matthew B. Spraker, Y. David Seo, Kimberly S. Smythe, Jean S. Campbell, et al.. 2022. “Neoadjuvant Therapy Induces a Potent Immune Response to Sarcoma, Dominated by Myeloid and B Cells”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-21-4239.

clinicaltrials.govStudy

Dendritic Cell Vaccine for Children and Adults With Sarcoma

Macarena De La Fuente, MD 2014. "Dendritic Cell Vaccine for Children and Adults With Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01803152.

All > Sarcoma > Soft Tissue Sarcoma