Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over NCI MSKCC-03034 LUDWIG-LUD2002-014, NCT00066729

Objectives

1. 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.
2. Determine the immunologic profile (NY-ESO-1 antibody, CD8+ cells, and delayed-type hypersensitivity) induced by this regimen in these patients.

Entry 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

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

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/mm³
• Platelet count at least 80,000/mm³
• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Jakob Dupont, MD, Protocol chair		Ph: 212-639-8984; 800-525-2225 Email: dupontj@mskcc.org

Registry Information
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 Expressing NY-ESO-1 or LAGE-1
Trial Start Date		2003-05-13
Registered in ClinicalTrials.gov		NCT00066729
Date Submitted to PDQ		2003-07-01
Information Last Verified		2006-04-01
NCI Grant/Contract Number		CA08748

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