Phase 1
N=9
Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Fallopian Tube Cancer · Ovarian Cancer · Primary Peritoneal Cavity Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00066729 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Number of Patients With Dose Limiting Toxicities (DLTs) — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- NY-ESO-1 peptide vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ludwig Institute for Cancer Research
- Primary completion
- May 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Dose Limiting Toxicities (DLTs) |
— | — |
| SECONDARY Number of Patients Developing NY-ESO-1 Antibodies After Treatment |
2; 7 | — |
| SECONDARY Number of Patients With NY-ESO-1b-Specific CD8+ T Cells Measured by Tetramer Analysis |
3; 1; 3; 2 | — |
| SECONDARY Number of Patients With NY-ESO-1b-Specific Activated CD8+ T Cells Measured by ELISPOT |
3; 1; 3; 2 | — |
| SECONDARY Number of Patients With NY-ESO-1b-specific Delayed-type Hypersensitivity (DTH) |
0; 9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
- 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.
- 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.
- Expected survival of at least 6 months.
- Karnofsky performance scale ≥60%.
- 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.
- 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:
- Clinically significant heart disease (NYHA Class III or IV).
- Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders.
- Patients with serious intercurrent illness, requiring hospitalization.
- Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available.
- Patients taking immunosuppressive drugs such as systemic corticosteroids or non-steroidal anti-inflammatory drugs.
- Known HIV positivity.
- Other malignancy within 3 years prior to entry into the study, except for treated nonmelanoma skin cancer and cervical carcinoma in situ.
- Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
- Lack of availability for immunological and clinical follow-up assessments.
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
- Pregnancy or breastfeeding.
- Women of childbearing potential: Refusal or inability to use effective means of contraception.
Data sourced from ClinicalTrials.gov (NCT00066729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.