Vaccine Therapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier:
NCT00112957
First received: June 2, 2005
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells.

PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage II, stage III, or stage IV ovarian epithelial, fallopian tube, or peritoneal cancer.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Biological: fowlpox-NY-ESO-1 vaccine
Biological: recombinant vaccinia-NY-ESO-1 vaccine
Procedure: adjuvant therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ludwig Institute for Cancer Research:

Primary Outcome Measures:
  • Remission rate at 1 month, every 2 months for 1 year, and then annually post-treatment [ Time Frame: every 2 months for 1 year, then annually ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • NY-ESO-1 specific cellular and humoral immunity at 1 month, every 2 months for 1 year, and then annually post-treatment [ Time Frame: 1 month, every 2 months for 1 year, and then annually post-treatment ] [ Designated as safety issue: No ]
  • Correlate time to treatment failure with vaccine-induced NY-ESO-1 antigen specific cellular or humoral immunity at 1 month, every 2 months for 1 year, and then annually post-treatment [ Time Frame: 1 month, every 2 months for 1 year, and then annually post-treatment ] [ Designated as safety issue: No ]
  • Safety at 1 month, every 2 months for 1 year, and then annually post-treatment [ Time Frame: 1 month, every 2 months for 1 year, and then annually post-treatment ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: July 2004
Study Completion Date: May 2010
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: fowlpox-NY-ESO-1 vaccine
    iv
    Biological: recombinant vaccinia-NY-ESO-1 vaccine
    iv
    Procedure: adjuvant therapy
    additional therapy
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00112957

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Ludwig Institute for Cancer Research
Investigators
Principal Investigator: Adekunle O. Odunsi, MD, PhD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier: NCT00112957     History of Changes
Other Study ID Numbers: CDR0000424461, RPCI-I-13303, LUDWIG-LUD2002-012
Study First Received: June 2, 2005
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Ludwig Institute for Cancer Research:
fallopian tube cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
peritoneal cavity cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases

ClinicalTrials.gov processed this record on August 28, 2014