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Phase II Study of Recombinant Vaccinia-NY-ESO-1 (rF-NY-ESO-1) and Recombinant Fowlpox-NY-ESO-1 (rF-NY-ESO-1) in Patients With Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma Whose Tumors Express NY-ESO-1 or LAGE-1 Antigen


Phase 2
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Thank you

Trial Information

Phase II Study of Recombinant Vaccinia-NY-ESO-1 (rF-NY-ESO-1) and Recombinant Fowlpox-NY-ESO-1 (rF-NY-ESO-1) in Patients With Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma Whose Tumors Express NY-ESO-1 or LAGE-1 Antigen


OBJECTIVES:

Primary

- Determine the remission rate in patients with NY-ESO-1 or LAGE-1 expressing stage II-IV
ovarian epithelial, fallopian tube, or primary peritoneal cancer who are still in
complete clinical remission 12 months after initial documentation of remission treated
with vaccine therapy comprising vaccinia-NY-ESO-1 vaccine and fowlpox-NY-ESO-1 vaccine.

Secondary

- Determine the NY-ESO-1 specific cellular and humoral immunity, by evaluating NY-ESO-1
specific antibody and CD8+ T cells induced by this regimen, in these patients.

- Correlate time to treatment failure with vaccine-induced NY-ESO-1 antigen specific
cellular or humoral immunity in these patients.

- Determine the safety of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive vaccinia-NY-ESO-1 vaccine intradermally on day 1 and fowlpox-NY-ESO-1
vaccine subcutaneously on days 29, 57, 85, 113, 141, and 169 in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 1 month, every 2 months for 1
year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study within 14-36
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

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

- Stage II-IV disease at diagnosis

- Tumor expression of 1 of the following:

- NY-ESO-1 by reverse transcription polymerase chain reaction (RT-PCR) analysis OR
immunohistochemistry

- LAGE-1 by RT-PCR

- Demonstrated complete response to prior first-line initial surgery and chemotherapy,
as evidenced by negative clinical examination, CA 125 tumor marker, and CT scan

- No evidence of microscopic or macroscopic disease by second look surgery (if
performed)

- Received ≥ 1 platinum-based chemotherapy regimen within the past 6 months

- No CNS metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 70-100%

Life expectancy

- At least 6 months

Hematopoietic

- Neutrophil count ≥ 1,500/mm^3

- Lymphocyte count ≥ 500/mm^3

- Platelet count ≥ 100,000/mm^3

- No bleeding disorder

Hepatic

- Bilirubin ≤ 2 mg/dL

Renal

- Creatinine ≤ 2 mg/dL

Cardiovascular

- No myocardial infarction

- No angina

- No congestive heart failure

- No cardiomyopathy

- No stroke or transient ischemic attack

- No chest pain or shortness of breath with activity

- No other heart condition being treated by a doctor

- No presence of ≥ 3 of the following cardiac risk factors:

- Hypertension

- Hypercholesterolemia

- Diabetes

- Has a first-degree relative (e.g., mother, father, brother, or sister) who had a
heart condition at < 50 years of age

- Current cigarette smoker

Immunologic

- No known allergy or severe reaction to a vaccinia (small pox) vaccination

- No known history of allergy to eggs

- No known HIV positivity

- No history of autoimmune disease (e.g., thyroiditis or lupus)

- No prior or current eczema or atopic dermatitis

- None of the following acute, chronic, or exfoliative skin conditions:

- Burns

- Chicken pox

- Shingles

- Impetigo

- Herpes

- Severe acne

- Psoriasis

- No serious infection requiring antibiotics

Other

- No other serious illness

- No mental impairment that would preclude giving informed consent or study compliance

- Able to avoid close contact with any of the following individuals while receiving the
study therapy:

- Children < 3 years of age

- Pregnant or nursing women

- Individuals with prior or active eczema or atopic dermatitis

- Individuals with other prior or active skin disorders, including any of the
following:

- Burns

- Chicken pox

- Shingles

- Impetigo

- Herpes

- Severe acne

- Psoriasis

- Immunocompromised individuals, including those with any of the following
conditions:

- HIV

- Leukemia

- Lymphoma

- Solid organ transplantation

- Generalized malignancy

- Cellular or humoral immunodeficiency syndromes

- Currently receiving cytotoxic chemotherapy, radiotherapy, or high-dose
corticosteroids

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 4 weeks since prior immunotherapy

Chemotherapy

- See Disease Characteristics

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

- No concurrent chemotherapy

Endocrine therapy

- No concurrent systemic corticosteroids

- Concurrent hormonal therapy for breast cancer allowed

- Concurrent tamoxifen therapy for ovarian cancer allowed

Radiotherapy

- More than 4 weeks since prior radiotherapy

Surgery

- See Disease Characteristics

- Recovered from prior surgery

Other

- More than 4 weeks since prior participation in a clinical trial involving another
investigational agent

- No concurrent systemic antihistamines

- No concurrent systemic nonsteroidal anti-inflammatory drugs

- No other concurrent immunosuppressive agents

- Concurrent noncytotoxic anticancer therapy allowed

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Remission rate at 1 month, every 2 months for 1 year, and then annually post-treatment

Outcome Time Frame:

every 2 months for 1 year, then annually

Safety Issue:

No

Principal Investigator

Adekunle O. Odunsi, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000424461

NCT ID:

NCT00112957

Start Date:

July 2004

Completion Date:

May 2010

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263