NCT00118313

Vaccine Therapy With or Without Imiquimod in Treating Patients Who Have Undergone Surgery for Stage II, Stage III, or Stage IV Melanoma

Completed Phase 1 Last updated 27 March 2020

What this trial tests

Phase 1 trial testing incomplete Freund's adjuvant in Melanoma (Skin). Completed in 28 July 2006.

Timeline

4 November 2004

Primary endpoint
28 July 2006

28 July 2006

Quick facts

Lead sponsor	Craig L Slingluff, Jr
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Masking	none
Primary purpose	treatment
Start date	4 November 2004
Primary completion	28 July 2006
Estimated completion	28 July 2006
Sites	1 location across United States

Drugs / interventions tested

• incomplete Freund's adjuvant
• multi-epitope melanoma peptide vaccine
• sargramostim (SARGRAMOSTIM) — full drug profile →
• tetanus toxoid helper peptide — full drug profile →
• dimethyl sulfoxide (DIMETHYL SULFOXIDE) — full drug profile →
• imiquimod (IMIQUIMOD) — full drug profile →
• adjuvant therapy — full drug profile →

Conditions studied

• Melanoma (Skin) — all drugs for Melanoma (Skin) →

Sponsor

Craig L Slingluff, Jr — full company profile →

Who can join

Adults 12 to 120, any sex, with Melanoma (Skin). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with imiquimod after surgery may help the body kill any remaining tumor cells.

PURPOSE: This randomized phase I trial is studying the side effects and best way to give vaccine therapy with or without imiquimod in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.

Publications & conference data

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

1. Trial watch: FDA-approved Toll-like receptor agonists for cancer therapy.
   Vacchelli E, Galluzzi L, Eggermont A, Fridman WH, et al · · 2012 · cited 178× · PMID 23162757 · DOI 10.4161/onci.20931
2. Dimethyl sulfoxide (DMSO) produces widespread apoptosis in the developing central nervous system.
   Hanslick JL, Lau K, Noguchi KK, Olney JW, et al · · 2009 · cited 151× · PMID 19100327 · DOI 10.1016/j.nbd.2008.11.006
3. Trial Watch: Immunostimulation with Toll-like receptor agonists in cancer therapy.
   Iribarren K, Bloy N, Buqué A, Cremer I, et al · · 2016 · cited 98× · PMID 27141345 · DOI 10.1080/2162402x.2015.1088631
4. Agonist and antagonist ligands of toll-like receptors 7 and 8: Ingenious tools for therapeutic purposes.
   Patinote C, Karroum NB, Moarbess G, Cirnat N, et al · · 2020 · cited 87× · PMID 32203790 · DOI 10.1016/j.ejmech.2020.112238
5. Pattern recognition receptors: function, regulation and therapeutic potential.
   Chen R, Zou J, Chen J, Zhong X, et al · · 2025 · cited 53× · PMID 40640149 · DOI 10.1038/s41392-025-02264-1
6. Plasmacytoid dendritic cells at the forefront of anti-cancer immunity: rewiring strategies for tumor microenvironment remodeling.
   Monti M, Ferrari G, Gazzurelli L, Bugatti M, et al · · 2024 · cited 22× · PMID 39020402 · DOI 10.1186/s13046-024-03121-9
7. Interface of signal transduction inhibition and immunotherapy in melanoma.
   Shada AL, Molhoek KR, Slingluff CL. · · 2010 · cited 7× · PMID 20693848 · DOI 10.1097/ppo.0b013e3181eb3393
8. Multi-disciplinary approaches paving the way for clinically effective peptide vaccines for cancer.
   Shah BA, Holden JA, Lenzo JC, Hadjigol S, et al · · 2025 · cited 6× · PMID 40204832 · DOI 10.1038/s41541-025-01118-9