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Cancer Vaccine
Vaccine Therapy in Stage II, III, or IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers
Phase 1
Waitlist Available
Research Sponsored by Ludwig Institute for Cancer Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and weeks 12 and 24
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This was a Phase 1, non-randomized, open-label, multicenter study of the ALVAC(2)-NY-ESO-1(M)/TRICOM vaccine administered with the granulocyte macrophage-colony stimulating factor (GM-CSF) sargramostim in patients with NY-ESO-1- or LAGE-1-positive epithelial ovarian, fallopian tube, or primary peritoneal cavity cancers who had completed standard therapy for primary or recurrent disease and would have normally entered a period of observation. The primary study objective was to determine the safety and tolerability of study vaccination, with secondary objectives including the determination of clinical and immunological responses.
Eligible Conditions
- Ovarian Cancer
- Peritoneal Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and weeks 12 and 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and weeks 12 and 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Patients With Treatment-emergent Adverse Events
Secondary study objectives
CA-125 Antigen
Median Progression-free Survival (PFS)
Number of Patients With Best Overall Tumor Response
+1 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ALVAC(2)-NY-ESO-1(M)/TRICOM + GM-CSFExperimental Treatment2 Interventions
Patients received SC injections with ALVAC(2)-NY-ESO-1(M)/TRICOM (0.5 mL) on Day 1 and the GM-CSF sargramostim (100 μg) on Days 1 through 4 in continuous 28-day cycles for up to 6 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sargramostim
FDA approved
ALVAC(2)-NY-ESO-1(M)/TRICOM vaccine
2008
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
New York University Cancer InstituteOTHER
3 Previous Clinical Trials
22 Total Patients Enrolled
Ludwig Institute for Cancer ResearchLead Sponsor
61 Previous Clinical Trials
1,647 Total Patients Enrolled
8 Trials studying Ovarian Cancer
273 Patients Enrolled for Ovarian Cancer
Roswell Park Cancer InstituteOTHER
412 Previous Clinical Trials
32,747 Total Patients Enrolled
3 Trials studying Ovarian Cancer
50 Patients Enrolled for Ovarian Cancer