NCT01946373

A Phase I Study to Evaluate Safety, Feasibility and Immunologic Response of Adoptive T Cell Transfer With or Without Dendritic Cell Vaccination in Patients With Metastatic Melanoma

Status unknown Phase 1 Last updated 3 October 2022

What this trial tests

Phase 1 trial testing Cyclophosphamide in Melanoma in 20 participants. Status unknown.

Timeline

1 October 2013

Primary endpoint
1 December 2025

1 December 2025

Quick facts

Lead sponsor	Karolinska University Hospital
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 October 2013
Primary completion	1 December 2025
Estimated completion	1 December 2025
Sites	1 location across Sweden

Drugs / interventions tested

• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Fludarabine (FLUDARABINE) — full drug profile →
• T cells
• Interleukin-2
• Dendritic cell vaccine — full drug profile →

Conditions studied

• Melanoma — all drugs for Melanoma →

Sponsor

Karolinska University Hospital

Who can join

Adults 18 to 74, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Safety of the T cell therapy, with and without dendritic cell vaccine, as evaluated according to the NCI CTCAE scale version 4.0
  Time frame: 30 days

Sponsor's own description

The purpose of this study is to learn if dendritic cell vaccine will increase the effect of tumor infiltrating lymphocytes given with chemotherapy and interleukin-2 in patients with melanoma.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunosuppressive cells in cancer: mechanisms and potential therapeutic targets.
   Tie Y, Tang F, Wei YQ, Wei XW. · · 2022 · cited 386× · PMID 35585567 · DOI 10.1186/s13045-022-01282-8
2. NY-ESO-1 Based Immunotherapy of Cancer: Current Perspectives.
   Thomas R, Al-Khadairi G, Roelands J, Hendrickx W, et al · · 2018 · cited 298× · PMID 29770138 · DOI 10.3389/fimmu.2018.00947
3. Adoptive transfer of tumor-infiltrating lymphocytes in melanoma: a viable treatment option.
   Rohaan MW, van den Berg JH, Kvistborg P, Haanen JBAG. · · 2018 · cited 147× · PMID 30285902 · DOI 10.1186/s40425-018-0391-1
4. Personalized Dendritic Cell Vaccines-Recent Breakthroughs and Encouraging Clinical Results.
   Mastelic-Gavillet B, Balint K, Boudousquie C, Gannon PO, et al · · 2019 · cited 145× · PMID 31031762 · DOI 10.3389/fimmu.2019.00766
5. Research progress on dendritic cell vaccines in cancer immunotherapy.
   Yu J, Sun H, Cao W, Song Y, et al · · 2022 · cited 130× · PMID 35074008 · DOI 10.1186/s40164-022-00257-2
6. Trial Watch: Chemotherapy with immunogenic cell death inducers.
   Vacchelli E, Aranda F, Eggermont A, Galon J, et al · · 2014 · cited 123× · PMID 24800173 · DOI 10.4161/onci.27878
7. Tumor Infiltrating Lymphocyte (TIL) Therapy for Solid Tumor Treatment: Progressions and Challenges.
   Zhao Y, Deng J, Rao S, Guo S, et al · · 2022 · cited 114× · PMID 36077696 · DOI 10.3390/cancers14174160
8. Immunotherapy Based on Dendritic Cell-Targeted/-Derived Extracellular Vesicles-A Novel Strategy for Enhancement of the Anti-tumor Immune Response.
   Markov O, Oshchepkova A, Mironova N. · · 2019 · cited 96× · PMID 31680949 · DOI 10.3389/fphar.2019.01152