Vaccine Therapy With Sargramostim (GM-CSF) in Treating Patients With Her-2 Positive Stage III-IV Breast Cancer or Ovarian Cancer

Phase 1 Completed 66 enrolled University of Washington National Cancer Institute (NCI) · collab

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy together with sargramostim may be an effective treatment for breast cancer and ovarian cancer. PURPOSE: This phase I trial is studying the side effects and identifying the best dose of vaccine therapy when given together with sargramostim in treating patients with stage III-IV breast cancer or ovarian cancer.

Timeline

Start: 2001-10
Primary completion: 2010-03
Completion: 2025-04-01

Publications

Disis MLN, Guthrie KA, Liu Y, Coveler AL, Higgins DM, Childs JS, Dang Y, Salazar LG. Safety and Outcomes of a Plasmid DNA Vaccine Encoding the ERBB2 Intracellular Domain in Patients With Advanced-Stage ERBB2-Positive Breast Cancer: A Phase 1 Nonrandomized Clinical Trial. JAMA Oncol. 2023 Jan 1;9(1):71-78. doi: 10.1001/jamaoncol.2022.5143.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AST-301	Vaccine	10 ug	Intrathecal
Subject	AST-301	Vaccine	100 ug	Intrathecal
Subject	AST-301	Vaccine	500 ug	Intrathecal
Background	sargramostim	Protein / enzyme biologic	—	Intrathecal

Vaccine Therapy With Sargramostim (GM-CSF) in Treating Patients With Her-2 Positive Stage III-IV Breast Cancer or Ovarian Cancer

Summary

Timeline

Publications

Drugs

Indications