Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

All Drugs and Chemicals

Vaccines

Monatide (IMS 3015)

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.

NY-ESO-1b peptide 100 μg mixed with 0.5 mL of Montanide® ISA-51

NY-ESO-1 peptide vaccine

Jakob Dupont, MD

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.

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.

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

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

Toxicities and adverse events defined by National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999). DLT defined as:

≥ Grade 2 autoimmune phenomena, asymptomatic bronchospasm or generalized urticaria, or ≥ Grade 3 hematological and non hematological toxicities. To be dose-limiting, an adverse event must be definitely, probably, or possibly related to the administration of the investigational agent.

Blood samples were obtained at baseline and in weeks 4, 7, 10, 13 and 16 for the assessment of NY-ESO-1 specific antibodies by enzyme-linked immunosorbent assay (ELISA).

Blood samples were obtained at baseline and at 4, 7, 10. 13 and 16 weeks. Tetramer assays were conducted after presensitization of CD8+ T cells with NY-ESO-1b. Results are presented separately for patients with NY-ESO-1 positive and negative tumors.

Blood samples were obtained at baseline and at 4, 7, 10, 13 and 16 weeks. T cell responses were monitored after the in vitro sensitization with NY-ESO-1b (157-165), modified NY-ESO-1b-A (157-165A), or control peptide influenza matrix 58 to 66. Results are presented separately for patients with NY-ESO-1 positive and negative tumors.

NY-ESO-1b-specific delayed-type hypersensitivity (DTH) was measured by number of patients with induration and/or redness at each timepoint.

NY-ESO-1b-specific DTH skin reaction was measured at baseline and weeks 7 and 16. The NY-ESO-1b peptide solution (0.1 mg/mL in 8% DMSO) was injected intradermally at a separate site from the vaccination to give a visable and palpable skin depot. The extent and intensity of DTH reactions were documented by measuring visible redness, palpable induration and other signs of local skin irritation or necrosis. Assessment of DTH reaction was performed 48 hours after injection, and the diameter of the reaction was documented.

National Cancer Institute (NCI)

Ludwig Institute for Cancer Research

All Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).

NY-ESO-1b Peptide With Montanide® ISA-51

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

NY-ESO-1 Tumor Expression

Jonathan Skipper PhD

All patients who entered the study and received treatment.

Number of Patients With Dose Limiting Toxicities (DLTs)

Number of Patients Developing NY-ESO-1 Antibodies After Treatment

Patients with NY ESO-1 Positive Tumors

Patients with NY-ESO-1 Negative Tumors

Number of Patients With NY-ESO-1b-Specific CD8+ T Cells Measured by Tetramer Analysis

Patients with NY-ESO-1 Positive Tumors

Number of Patients With NY-ESO-1b-Specific Activated CD8+ T Cells Measured by ELISPOT

All patients who entered the study, received treatment and had at least 1 post-baseline DTH test.

Number of Patients With NY-ESO-1b-specific Delayed-type Hypersensitivity (DTH)

Week 16 (End of Study)

Month 52 (last follow-up)

Although clinical outcome was not an endpoint of this study, patients were evaluated for disease progression throughout the study by cancer antigen 125 (CA-125) levels, physical examination and at the time of study completion with CT scan. All patients enrolled in the study were confirmed to be in Complete Response (cCR) at the initiation of therapy, as documented by CA-125 at \<35 units/mL, physical examination, and CT scan without evidence of disease. Patients were assessed for disease progression by CA-125 during the study at weeks 7 and 16. CT scan was done after completion of the study (week 16). After completion of the study, patients returned to the care of their primary treating oncologist, and monitoring was at the discretion of the treating physician.

No evidence of disease (NED) was defined as no consistent increase in CA-125 or evidence of new lesions on CT scans. Progression was defined as the appearance of new lesions on CT scan.

Spots Global Cancer Trial Database for Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

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