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Vaccine Therapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
This study has been completed.

First Received on December 4, 2008.   Last Updated on June 21, 2011   History of Changes
Sponsor: Ludwig Institute for Cancer Research
Information provided by: Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier: NCT00803569
  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 I trial is studying the side effects of vaccine therapy in treating patients with stage II, stage III, or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Biological: ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine
Biological: sargramostim
Phase I

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of ALVAC(2)-NY-ESO-1(M)/TRICOM 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:
  • Safety and tolerability as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor response as assessed by RECIST criteria [ Designated as safety issue: No ]
  • Immune response (humoral and cellular immunity) [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: November 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the safety and tolerability of ALVAC(2)-NY-ESO-1(M)/TRICOM vaccine in patients with stage II-IV ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer.

Secondary

  • Determine the tumor response in patients treated with this regimen.
  • Determine the immune response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive ALVAC(2)-NY-ESO-1(M)/TRICOM vaccine subcutaneously (SC) on day 1 and sargramostim (GM-CSF) SC on days 1-4. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

  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 cavity cancer

    • Stage II-IV disease
  • Tumor expresses 1 of the following antigens:

    • NY-ESO-1 by RT-PCR or IHC
    • LAGE-1 by RT-PCR
  • Previously treated with initial surgery AND ≥ 1 platinum-based chemotherapy regimen
  • Must have demonstrated complete response to prior front-line therapy as evidenced by negative clinical examination, no objective evidence of disease progression by CT scan, and serum CA-125 ≤ 35 IU/mL

    • If second-look surgery was performed, patient may have either a negative or microscopic positive second-look surgery (laparoscopy or laparotomy)
  • Recurrent disease allowed provided patient completed surgery and/or chemotherapy for recurrent disease

    • Patient may have asymptomatic residual measurable disease by physical examination and/or CT scan and/or elevated CA-125 or may be in complete clinical remission
  • No CNS metastases

PATIENT CHARACTERISTICS:

  • Karnofsky performance status ≥ 70%
  • Life expectancy ≥ 6 months
  • ANC ≥ 1,500/mm^3
  • WBC ≥ 5,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL
  • Serum creatinine ≤ 2 mg/dL
  • Serum bilirubin ≤ 2 mg/dL
  • No history of autoimmune disease (e.g., thyroiditis or lupus), except vitiligo
  • No known immunodeficiency or HIV positivity
  • No known allergy or history of life threatening reaction to sargramostim (GM-CSF)
  • No known history of allergies to eggs, neomycin, or bovine products
  • No history of severe allergic reactions to vaccines or unknown allergens
  • None of the following cardiovascular conditions:

    • Myocardial infarction
    • Angina
    • Congestive heart failure
    • Cardiomyopathy
    • Stroke or transient ischemic attack
    • Chest pain or shortness of breath with activity
    • Other heart conditions being treated by a doctor
  • No other serious illness (e.g., serious infections requiring antibiotics or bleeding disorders)
  • No other malignancy within the past 3 years, except previously treated nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No mental impairment that may compromise the ability to give informed consent and comply with study requirements

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior surgery
  • More than 4 weeks since prior and no concurrent chemotherapy (6 weeks for nitrosoureas), radiotherapy, immunotherapy, or other anticancer therapy

    • Concurrent hormonal or hormonal-related anticancer therapy allowed
  • More than 4 weeks since prior participation in another clinical trial involving an investigational agent
  • No prior NY-ESO-1 vaccine therapy
  • No concurrent systemic corticosteroids, antihistamines, non-steroidal anti-inflammatory drugs, or other immunosuppressants

    • Concurrent low-dose aspirin (≤ 100 mg/day) or specific COX-2 inhibitors allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00803569

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
Ludwig Institute for Cancer Research
Investigators
Study Chair: Adekunle O. Odunsi, MD, PhD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Adekunle Omotayo Odunsi, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00803569     History of Changes
Other Study ID Numbers: CDR0000628730, LUDWIG-LUD2007-005
Study First Received: December 4, 2008
Last Updated: June 21, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
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
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 09, 2012