Brief Title
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
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Number of Patients With Dose Limiting Toxicities (DLTs)
Secondary Outcome
Number of Patients Developing NY-ESO-1 Antibodies After Treatment
Condition
Fallopian Tube Cancer
Intervention
NY-ESO-1 peptide vaccine
Study Arms / Comparison Groups
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
9
Start Date
June 23, 2003
Completion Date
August 1, 2013
Primary Completion Date
May 9, 2006
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jakob Dupont, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00066729
Organization ID
CDR0000318803
Secondary IDs
MSKCC-03034
Responsible Party
Sponsor
Study Sponsor
Ludwig Institute for Cancer Research
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Jakob Dupont, MD, Study Chair, Memorial Sloan Kettering Cancer Center
Verification Date
August 2021