CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
rV-NY-ESO-1 vaccine +1 morebiological
Likely dose
rV-NY-ESO-1: 3.1 × 10⁷ PFU single intradermal injection on Day 1; rF-NY-ESO-1: 7.41 × 10⁷ PFU subcutaneous injections on Days 29, 57, 85, 113, 141, and 169AI-extracted
Key inclusion· 8
  • ✓Histologically documented epithelial carcinoma of ovary, fallopian tube, or peritoneum, stage II–IV at diagnosis
  • ✓Completed initial surgery and at least one platinum-based chemotherapy regimen
  • ✓Complete response to first-line therapy (negative clinical exam, CA-125, CT scan; no disease on second-look surgery if performed) within 6 months of completing chemotherapy
  • ✓Tumor expression of NY-ESO-1 (by RT-PCR preferably or immunohistochemistry) or LAGE-1 (by RT-PCR)
Key exclusion· 9
  • ✕Metastatic disease to central nervous system for which other therapeutic options were available
  • ✕Serious illnesses (serious infections requiring antibiotics, bleeding disorders)
  • ✕History or current eczema, atopic dermatitis, or other acute/chronic/exfoliative skin conditions
  • ✕History of autoimmune disease (thyroiditis, lupus, etc.)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00112957
NCT00112957Phase 2Completed
CompareCT.gov

Phase II Study of Recombinant Vaccinia-NY-ESO-1 (rV-NY-ESO-1) and Recombinant Fowlpox-NY-ESO-1 (rF-NY-ESO-1) in Patients With Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma Whose Tumors Express NY-ESO-1 or LAGE-1 Antigen

Ludwig Institute for Cancer Research·interventional·Posted Jun 3, 2005·Updated Oct 4, 2023

In Brief

A Phase 2 clinical trial evaluating rV-NY-ESO-1 vaccine and rF-NY-ESO-1 vaccine for Fallopian Tube Cancer and 2 related conditions. Completed, enrolled 23 participants across 1 site.

Detailed Summary

This was a Phase 2, single-center, open-label study of recombinant vaccinia-NY-ESO-1 (rV-NY-ESO-1) and recombinant fowlpox-NY-ESO-1 (rF-NY-ESO-1) injections in patients who had a complete response to standard therapy for epithelial ovarian, fallopian tube, or primary peritoneal carcinoma and whose tumors expressed NY-ESO-1 or LAGE-1 antigen. Study objectives were to evaluate maintenance of remission at 12 months, time to failure of vaccine therapy, cellular and humoral immunity and any correlation with time to failure, and safety.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
CountriesUnited States
CollaboratorsRoswell Park Cancer Institute

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 3, 2005
Enrollment StartDec 1, 2004
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 21.1 years ago

Interventions

rV-NY-ESO-1 vaccinebiological

Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10\^7 PFU) on Day 1.

rF-NY-ESO-1 vaccinebiological

Patients received subcutaneous injections of rF-NY-ESO-1 (7.41 × 10\^7 PFU) on Days 29, 57, 85, 113, 141, and 169.