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A Phase I Study Of NY-ESO-1b Peptide Plus Montanide ISA-51 In Patients With Ovarian, Primary Peritoneal, Or Fallopian Tube Cancer Expressing NY-ESO-1 or LAGE-1


Phase 1
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase I Study Of NY-ESO-1b Peptide Plus Montanide ISA-51 In Patients With Ovarian, Primary Peritoneal, Or Fallopian Tube Cancer Expressing NY-ESO-1 or LAGE-1


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 expressing NY-ESO-1 or
LAGE-1.

- 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 and then every 6-12 weeks for 2 years or until disease
progression.

PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube
cancer

- Stage II-IV at diagnosis

- Previously treated with cytoreductive surgery and at least 1 platinum-based
chemotherapy regimen

- High-risk feature, defined as 1 of the following:

- Suboptimal primary debulking (remaining tumor masses with diameter at least 1.0
cm)

- Failure to normalize CA 125 during primary therapy by the end of the third
course

- Complete clinical remission, defined as all of the following:

- CA 125 less than 35 units

- Negative physical examination

- No definite evidence of disease by CT scan of the abdomen and pelvis* NOTE:
*Lymph nodes and/or soft tissue abnormalities in the pelvis, no greater than 1.0
cm, are not considered definite evidence of disease

- HLA-A2 positive

- Tumor expression of 1 of the following proteins:

- NY-ESO-1 by reverse transcriptase and polymerase chain reaction (RT-PCR)
analysis or immunohistochemistry

- LAGE-1 by RT-PCR

- No more than 4 months since prior primary therapy

- No CNS metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 60-100%

Life expectancy

- At least 6 months

Hematopoietic

- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 80,000/mm^3

- No bleeding disorders

Hepatic

- Bilirubin less than 2.5 times upper limit of normal (ULN)

- ALT and AST less than 2.5 times ULN

Renal

- Creatinine no greater than 1.5 mg/dL

Cardiovascular

- No New York Heart Association class III or IV heart disease

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- HIV negative

- No serious infections requiring antibiotics

- No serious concurrent illness requiring hospitalization

- No other malignancy within the past 3 years except treated nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No mental impairment that would preclude giving informed consent or complying with
study requirements

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

- No concurrent chemotherapy

Endocrine therapy

- Concurrent tamoxifen is allowed

- No concurrent systemic corticosteroids

Radiotherapy

- Not specified

Surgery

- See Disease Characteristics

Other

- More than 4 weeks since prior participation in any other investigational study

- Concurrent non-cytotoxic anticancer therapy allowed

- No concurrent immunosuppressive drugs

- No concurrent nonsteroidal anti-inflammatory drugs except as low dose for the
prevention of acute cardiovascular events or for pain control

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Jakob Dupont, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000318803

NCT ID:

NCT00066729

Start Date:

May 2003

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • fallopian tube cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021