Clinical trial · Interventional
Use of ACA 125 in Patients With Ovarian Cancer: Safety and Immune Response
A Phase I/II Trial of ACA 125 in Patients With Recurrent Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
NCT00103545CI-TRIAL-00000461completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to use an immunologic approach following the treatment for recurrent disease in patients with ovarian, fallopian tube, or peritoneal cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Neoplasms | Fallopian Tube Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Neoplasms | Peritoneal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ACA 125 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Safety, feasibility and tolerability
- measure
- The primary endpoint is drop-out due to toxicity as the overall measure of feasibility
Secondary outcomes (1)
- measure
- Duration and strength of the immune response induced by ACA 125 vaccination
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 0 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with epithelial carcinoma arising in the ovary, fallopian tube or peritoneum, stages I-IV. These patients must have received initial surgery and chemotherapy with at least one platinum based chemotherapy regimen. * Patients must have relapsed and now have completed chemotherapy for recurrent disease within the last 6 weeks. * Eligible patients may have asymptomatic residual measurable disease on CT scan, and/or may have an elevated CA-125, or may be in complete clinical remission. * Patients must have adequate hematologic, renal and hepatic functions. Exclusion Criteria: * Patients with any other active malignancy concomitantly * Patients within 3 weeks of prior cytotoxic or investigational chemotherapy * Patients within 4 weeks of prior radiotherapy * Patients within 6 weeks of prior immunotherapy * Patients who have received any prior anti-cancer vaccine
References
Publications (1)
- BACKGROUNDPfisterer J, du Bois A, Sehouli J, Loibl S, Reinartz S, Reuss A, Canzler U, Belau A, Jackisch C, Kimmig R, Wollschlaeger K, Heilmann V, Hilpert F. The anti-idiotypic antibody abagovomab in patients with recurrent ovarian cancer. A phase I trial of the AGO-OVAR. Ann Oncol. 2006 Oct;17(10):1568-77. doi: 10.1093/annonc/mdl357. PMID 17005631