NCT00639639: ATTAC

Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Completed Phase 1 Last updated 13 March 2023

What this trial tests

Phase 1 trial testing tetanus toxoid in Malignant Neoplasms of Brain in 42 participants. Completed in 1 June 2022.

Timeline

6 February 2006

Primary endpoint
15 April 2017

1 June 2022

Quick facts

Lead sponsor	Gary Archer Ph.D.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	6 February 2006
Primary completion	15 April 2017
Estimated completion	1 June 2022
Sites	1 location across United States

Drugs / interventions tested

• tetanus toxoid — full drug profile →
• therapeutic autologous dendritic cells — full drug profile →
• therapeutic autologous lymphocytes — full drug profile →

Conditions studied

• Malignant Neoplasms of Brain — all drugs for Malignant Neoplasms of Brain →

Sponsor

Gary Archer Ph.D. — full company profile →

Who can join

18 and older, any sex, with Malignant Neoplasms of Brain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

RATIONALE: Vaccines may help the body build an effective immune response to kill cancer cells. Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving vaccine therapy together with radiation therapy and chemotherapy may kill more cancer cells.

PURPOSE: This randomized phase I/II trial is studying how well vaccine therapy works in treating patients with newly diagnosed glioblastoma multiforme recovering from lymphopenia caused by temozolomide.

Publications & conference data

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

1. mRNA vaccines - a new era in vaccinology.
   Pardi N, Hogan MJ, Porter FW, Weissman D. · · 2018 · cited 3231× · PMID 29326426 · DOI 10.1038/nrd.2017.243
2. mRNA-based therapeutics: powerful and versatile tools to combat diseases.
   Qin S, Tang X, Chen Y, Chen K, et al · · 2022 · cited 521× · PMID 35597779 · DOI 10.1038/s41392-022-01007-w
3. Tetanus toxoid and CCL3 improve dendritic cell vaccines in mice and glioblastoma patients.
   Mitchell DA, Batich KA, Gunn MD, Huang MN, et al · · 2015 · cited 416× · PMID 25762141 · DOI 10.1038/nature14320
4. Advances in COVID-19 mRNA vaccine development.
   Fang E, Liu X, Li M, Zhang Z, et al · · 2022 · cited 368× · PMID 35322018 · DOI 10.1038/s41392-022-00950-y
5. Clinical advances and ongoing trials on mRNA vaccines for cancer treatment.
   Lorentzen CL, Haanen JB, Met Ö, Met Ö, et al · · 2022 · cited 362× · PMID 36174631 · DOI 10.1016/s1470-2045(22)00372-2
6. Dendritic cell biology and its role in tumor immunotherapy.
   Wang Y, Xiang Y, Xin VW, Wang XW, et al · · 2020 · cited 324× · PMID 32746880 · DOI 10.1186/s13045-020-00939-6
7. mRNA vaccine: a potential therapeutic strategy.
   Wang Y, Zhang Z, Luo J, Han X, et al · · 2021 · cited 286× · PMID 33593376 · DOI 10.1186/s12943-021-01311-z
8. mRNA therapeutics in cancer immunotherapy.
   Beck JD, Reidenbach D, Salomon N, Sahin U, et al · · 2021 · cited 266× · PMID 33858437 · DOI 10.1186/s12943-021-01348-0