Trials / Completed
CompletedNCT01536054
Sirolimus and Vaccine Therapy in Treating Patients With Stage II-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
A Phase I Clinical Trial of mTOR Inhibition With Sirolimus for Enhancing ALVAC(2)-NY-ESO-1(M)/TRICOM Vaccine Induced Anti-Tumor Immunity in Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- Roswell Park Cancer Institute · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase I trial studies the side effects and best dose and schedule of sirolimus when given together with vaccine therapy in treating patients with stage II-IV ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer. Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with sirolimus may be an effective treatment for ovarian, fallopian tube, or primary peritoneal cancer
Detailed description
PRIMARY OBJECTIVES: I. Determine the safety of ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine with sirolimus at varying dose and schedule. SECONDARY OBJECTIVES: I. To determine the effectiveness of sirolimus on enhancing vaccine efficacy by assessing NY-ESO-1 specific cellular and humoral immunity: peripheral blood NY-ESO-1 specific cluster of differentiation (CD)8+ and CD4+ T-cells; peripheral blood NY-ESO-1 specific antibodies; peripheral blood frequency of CD4+CD25+forkhead box P3 (FOXP3)+ regulatory T-cells. II. Explore time to disease progression. OUTLINE: This is a dose-escalation study of sirolimus. Patients receive ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine subcutaneously (SC) on day 1 and sargramostim (GM-CSF) SC on days 1-4. Patients also receive sirolimus orally (PO) once daily (QD) on days 1-14 OR 15-28 OR 1-28. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive an additional course of ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine only followed by ALVAC(2)-NY-ESO-I (M)/TRICOM vaccine SC 8 weeks after completion of course 4. After completion of study treatment, patients are followed up at 30 days, and 6 and 12 months.
Conditions
- Recurrent Fallopian Tube Cancer
- Recurrent Ovarian Epithelial Cancer
- Recurrent Primary Peritoneal Cavity Cancer
- Stage IIA Fallopian Tube Cancer
- Stage IIA Ovarian Epithelial Cancer
- Stage IIA Primary Peritoneal Cavity Cancer
- Stage IIB Fallopian Tube Cancer
- Stage IIB Ovarian Epithelial Cancer
- Stage IIB Primary Peritoneal Cavity Cancer
- Stage IIC Fallopian Tube Cancer
- Stage IIC Ovarian Epithelial Cancer
- Stage IIC Primary Peritoneal Cavity Cancer
- Stage IIIA Fallopian Tube Cancer
- Stage IIIA Ovarian Epithelial Cancer
- Stage IIIA Primary Peritoneal Cavity Cancer
- Stage IIIB Fallopian Tube Cancer
- Stage IIIB Ovarian Epithelial Cancer
- Stage IIIB Primary Peritoneal Cavity Cancer
- Stage IIIC Fallopian Tube Cancer
- Stage IIIC Ovarian Epithelial Cancer
- Stage IIIC Primary Peritoneal Cavity Cancer
- Stage IV Fallopian Tube Cancer
- Stage IV Ovarian Epithelial Cancer
- Stage IV Primary Peritoneal Cavity Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine | Given SC |
| DRUG | sirolimus | Given PO |
| OTHER | laboratory biomarker analysis | Correlative studies |
| BIOLOGICAL | sargramostim | Given SC |
Timeline
- Start date
- 2012-08-20
- Primary completion
- 2015-04-21
- Completion
- 2015-04-21
- First posted
- 2012-02-20
- Last updated
- 2020-03-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01536054. Inclusion in this directory is not an endorsement.