Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
A Phase I Study Of NY-ESO-1b Peptide Plus Montanide ® ISA-51 In Patients With Ovarian, Primary Peritoneal, Or Fallopian Tube Cancer
NCT00066729CI-TRIAL-00070174completedPhase 1Results postedClinicalTrials.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)
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.
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 Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NY-ESO-1 peptide vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NY-ESO-1b peptide with Montanide® ISA-51
- description
- Patients received NY-ESO-1b peptide mixed with Montanide® ISA-51 by subcutaneous injections, once every 3 weeks (weeks 1, 4, 7, 10, and 13) for a total of 13 weeks.
- interventionNames
- Biological: NY-ESO-1 peptide vaccine
Primary outcomes (1)
- measure
- Number of Patients With Dose Limiting Toxicities (DLTs)
- timeFrame
- up to 16 weeks
- description
- Toxicities and adverse events defined by National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999). DLT defined as: ≥ Grade 2 autoimmune phenomena, asymptomatic bronchospasm or generalized urticaria, or ≥ Grade 3 hematological and non hematological toxicities. To be dose-limiting, an adverse event must be definitely, probably, or possibly related to the administration of the investigational agent.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria 1. Histologically documented epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum, from Stage II-IV at diagnosis, receiving initial cytoreductive surgery and chemotherapy with at least one platinum-based chemotherapy regimen. 2. High risk feature defined as suboptimal primary debulking (remaining tumor masses with diameter ≥ 1.0 cm) or failure to normalize CA125 during primary therapy by the end of the third cycle or positive second-look surgery. 3. Patients must be in complete clinical remission defined as CA125 \< 35 units, negative physical examination and no definite evidence of disease by computed tomography (CT) of the abdomen and pelvis. Lymph nodes and/or soft tissue abnormalities ≤ 1.0 cm that are often present in the pelvis may not be considered definite evidence of disease. 4. Expected survival of at least 6 months. 5. Karnofsky performance scale ≥60%. 6. Within the last 2 weeks prior to study day 1, vital laboratory parameters should be within normal range, except for the following laboratory parameters, which should be within the ranges specified: * Absolute neutrophil count (ANC) ≥1000/mm\^3 * Platelets ≥ 80,000/mm\^3 * Creatinine ≤ 1.5mg/dL * Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), and total bilirubin all \< 2.5 x upper limit of normal (ULN) 7 Age ≥ 18 years. 8\. Able and willing to give valid written informed consent. 9. HLA A02 positive. Exclusion Criteria Patients were excluded from the study for any of the following reasons: 1. Clinically significant heart disease (NYHA Class III or IV). 2. Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders. 3. Patients with serious intercurrent illness, requiring hospitalization. 4. Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available. 5. Patients taking immunosuppressive drugs such as systemic corticosteroids or non-steroidal anti-inflammatory drugs. 6. Known HIV positivity. 7. Other malignancy within 3 years prior to entry into the study, except for treated nonmelanoma skin cancer and cervical carcinoma in situ. 8. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study. 9. Lack of availability for immunological and clinical follow-up assessments. 10. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment. 11. Pregnancy or breastfeeding. 12. Women of childbearing potential: Refusal or inability to use effective means of contraception.
References
Publications (1)
- RESULTDiefenbach CS, Gnjatic S, Sabbatini P, Aghajanian C, Hensley ML, Spriggs DR, Iasonos A, Lee H, Dupont B, Pezzulli S, Jungbluth AA, Old LJ, Dupont J. Safety and immunogenicity study of NY-ESO-1b peptide and montanide ISA-51 vaccination of patients with epithelial ovarian cancer in high-risk first remission. Clin Cancer Res. 2008 May 1;14(9):2740-8. doi: 10.1158/1078-0432.CCR-07-4619. PMID 18451240