NCT01042535

Vaccine Therapy and 1-MT in Treating Patients With Metastatic Breast Cancer

A Phase 1/2 Study of Ad.p53 DC Vaccine in Combination With 1-methyl-D-tryptophan in Metastatic Solid Tumors and Invasive Breast Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase I/II trial studies the side effects and best dose of vaccine therapy and to see how well it works when given together with 1-methyl-D-tryptophan (1-MT) in treating patients with metastatic breast cancer. Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) and safety using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, of the combination Ad.p53 DC vaccine (adenovirus-p53 transduced dendritic cell vaccine) plus 1-MT in patients with any solid malignancy that has mutated p53 by immunohistochemistry (IHC). (Phase I) II. To determine efficacy (objective response rate) of the combination Ad.p53 DC vaccine plus 1-MT in metastatic breast cancer patients whose tumor expresses mutated p53 by IHC. (Phase II) SECONDARY OBJECTIVES: I. To collect preliminary data on and study the p53 specific interferon-gamma (IFN-gamma) enzyme-linked immunosorbent spot (ELISPOT) measurement at baseline, week 7 and week 16. (Phase I) II. To collect preliminary data on and study the percentage of p53 specific IFN-gamma ELISPOT responders at week 7 and 16. (Phase II) III. To collect preliminary data on and study progression-free survival on the study treatment. (Phase II) IV. To collect preliminary data on and study response and progression-free survival on the subsequent chemotherapy if administered. (Phase II) V. To collect preliminary data on and study the effects of 1-methyl-D-tryptophan (1-MT) on serum kynurenine, serum tryptophan, C reactive protein, and circulating T-regulatory cells (clusters of differentiation (CD)4+ 25+ CD127low forkhead box P3+ (FoxP3+)) by flow cytometry at each vaccination point on study when compared their corresponding baseline. (Phase II) OUTLINE: This is a phase I, dose escalation study followed by a phase II study. Patients receive adenovirus-p53 transduced dendritic cell vaccine intradermally (ID) in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Patients also receive 1-methyl-d-tryptophan orally (PO) once daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 4 weeks.

Conditions

• Male Breast Cancer
• Recurrent Breast Cancer
• Stage IV Breast Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
BIOLOGICAL	adenovirus-p53 transduced dendritic cell (DC) vaccine	Given intradermally (ID)
DRUG	1-methyl-d-tryptophan	Given orally (PO)
OTHER	Laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2009-12-28
• Primary completion: 2014-12-01
• Completion: 2018-02-27
• First posted: 2010-01-05
• Last updated: 2018-04-11
• Results posted: 2015-03-05

Locations

1 site across 1 country: United States