Clinical trial NCT00066729: Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Official title: A Phase I Study Of NY-ESO-1b Peptide Plus Montanide ® ISA-51 In Patients With Ovarian, Primary Peritoneal, Or Fallopian Tube Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Keywords: stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
primary peritoneal cavity cancer
fallopian tube cancer
Lead sponsor: Ludwig Institute for Cancer Research
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-08-07
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: OBJECTIVES:

* Determine the safety of NY-ESO-1b peptide vaccine and Montanide® ISA-51 in patients with ovarian epithelial, primary peritoneal, or fallopian tube cancer.
* Determine the immunologic profile (NY-ESO-1 antibody, CD8+ cells, and delayed-type hypersensitivity) induced by this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive NY-ESO-1b peptide vaccine emulsified with Montanide® ISA-51 subcutaneously once every 3 weeks on weeks 1, 4, 7, 10, and 13 in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 weeks (week 16) and then every 6-12 weeks for 2 years or until disease progression.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Patients With Dose Limiting Toxicities (DLTs)
timeFrame: up to 16 weeks
Secondary outcomes:
measure: Number of Patients Developing NY-ESO-1 Antibodies After Treatment
timeFrame: up to 16 weeks
measure: Number of Patients With NY-ESO-1b-Specific CD8+ T Cells Measured by Tetramer Analysis
timeFrame: up to 16 weeks.
measure: Number of Patients With NY-ESO-1b-Specific Activated CD8+ T Cells Measured by ELISPOT
timeFrame: up to 16 weeks
measure: Number of Patients With NY-ESO-1b-specific Delayed-type Hypersensitivity (DTH)
timeFrame: up to 16 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jakob Dupont, MD
role: STUDY_CHAIR
References:
citation: Diefenbach 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.