CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 9 enrolled
Drug / intervention
NY-ESO-1 peptide vaccinebiological
Likely dose
NY-ESO-1b peptide 100 μg mixed with 0.5 mL Montanide® ISA-51AI-extracted
Key inclusion· 6
  • ✓Histologically confirmed epithelial carcinoma of ovary, fallopian tube, or peritoneum, Stage II-IV at diagnosis, treated with cytoreductive surgery and platinum-based chemotherapy.
  • ✓High-risk disease: suboptimal debulking (residual tumor ≥1.0 cm) OR failure to normalize CA125 by end of cycle 3 OR positive second-look surgery.
  • ✓Complete clinical remission: CA125 <35 units, negative physical exam, no definite disease on CT abdomen/pelvis (lymph nodes/soft tissue ≤1.0 cm acceptable).
  • ✓HLA-A2 positive.
Key exclusion· 10
  • ✕Clinically significant heart disease (NYHA Class III or IV).
  • ✕Serious intercurrent illnesses (infections requiring antibiotics, bleeding disorders, hospitalization-level conditions).
  • ✕Brain metastases for which other therapeutic options (including radiotherapy) are available.
  • ✕Current immunosuppressive medications (systemic corticosteroids, NSAIDs).

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

Search/NCT00066729
NCT00066729Phase 1Completed
CompareCT.gov

A Phase I Study Of NY-ESO-1b Peptide Plus Montanide ® ISA-51 In Patients With Ovarian, Primary Peritoneal, Or Fallopian Tube Cancer

Ludwig Institute for Cancer Research·interventional·Posted Aug 7, 2003·Updated Oct 4, 2023

In Brief

A Phase 1 clinical trial evaluating NY-ESO-1 peptide vaccine for Fallopian Tube Cancer and 2 related conditions. Completed, enrolled 9 participants across 1 site.

Detailed Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: A phase I trial to study the side effects of vaccine therapy in patients with ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 1CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 7, 2003
Enrollment StartJun 23, 2003
Primary CompletionMay 9, 2006
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 22.9 years ago

Interventions

NY-ESO-1 peptide vaccinebiological

NY-ESO-1b peptide 100 μg mixed with 0.5 mL of Montanide® ISA-51