What is the mechanism of action of this treatment?

Common treatments for sarcoma, such as dendritic cell vaccines, work by stimulating the immune system to recognize and attack cancer cells. These vaccines use patient-derived dendritic cells to present tumor antigens to the immune system, effectively 'teaching' it to target and destroy sarcoma cells. This approach is significant for sarcoma patients as it offers a personalized treatment option that harnesses the body's natural defenses, potentially leading to more effective and targeted cancer eradication with fewer side effects compared to traditional therapies.

What side effects are associated with this type of intervention?

Common treatments for sarcoma, including immunotherapy like dendritic cell vaccines, can cause side effects such as flu-like symptoms, fatigue, fever, chills, and injection site reactions. Chemotherapy agents like doxorubicin and ifosfamide may lead to nausea, vomiting, hair loss, myelosuppression, and cardiotoxicity. Both approaches aim to treat sarcoma but have different side effect profiles.

What prior FDA approvals exist?

The FDA has approved several treatments for sarcoma, including traditional chemotherapies and targeted therapies. However, immunotherapies specifically designed to stimulate the immune system, such as dendritic cell vaccines, are still largely experimental. One example of an FDA-approved immunotherapy for cancer is sipuleucel-T, which is used for prostate cancer and works by stimulating the patient's immune system to attack cancer cells. While not specific to sarcoma, this approach is similar to the investigational dendritic cell vaccine being studied for sarcoma, which aims to use patient-derived cells to elicit an immune response against the tumor.

What other types of research exist?

Promising novel alternatives to Dendritic Cell Vaccine for sarcoma patients include: 1) Immune checkpoint inhibitors, which help to release the brakes on the immune system, allowing it to attack cancer cells more effectively. 2) Chimeric Antigen Receptor (CAR)-T cell therapies, which involve modifying a patient's T cells to better recognize and attack cancer cells. 3) Tumor-infiltrating lymphocyte (TIL) therapy, which involves extracting and expanding a patient's own immune cells that have infiltrated the tumor, then re-infusing them to fight the cancer. These therapies are currently being tested in clinical trials and show potential for treating sarcoma.

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Cancer Vaccine

Dendritic Cell Vaccine for Sarcoma

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

Must not have

Documented immunodeficiency or autoimmune disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new vaccine made from a patient's own immune and tumor cells to treat sarcoma. The vaccine uses special white blood cells to help the body recognize and attack cancer. This approach targets patients with sarcoma who may not respond well to standard treatments.

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.

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.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a condition that affects my immune system.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Secondary study objectives

Measurement levels of Myeloid Derived Supressor Cells after Gemcitabine treatment

Therapeutic procedure

Overall Survival

+2 more

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

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

Dendritic Cells Vaccine

2014

Completed Phase 1

~20

Lysate of Tumor

2014

Completed Phase 1

~20

Imiquimod

2005

Completed Phase 4

~2010

Leukapheresis

2016

Completed Phase 2

~710

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for sarcoma, such as dendritic cell vaccines, work by stimulating the immune system to recognize and attack cancer cells. These vaccines use patient-derived dendritic cells to present tumor antigens to the immune system, effectively 'teaching' it to target and destroy sarcoma cells. This approach is significant for sarcoma patients as it offers a personalized treatment option that harnesses the body's natural defenses, potentially leading to more effective and targeted cancer eradication with fewer side effects compared to traditional therapies.

A changing world for DCvax: a PSMA loaded autologous dendritic cell vaccine for prostate cancer.