Status:
COMPLETED
Vaccine Therapy in Stage II, III, or IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers
Lead Sponsor:
Ludwig Institute for Cancer Research
Collaborating Sponsors:
Roswell Park Cancer Institute
New York University Cancer Institute
Conditions:
Fallopian Tube Cancer
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
This was a Phase 1, non-randomized, open-label, multicenter study of the ALVAC(2)-NY-ESO-1(M)/TRICOM vaccine administered with the granulocyte macrophage-colony stimulating factor (GM-CSF) sargramosti...
Detailed Description
Patients received subcutaneous (SC) injections with 0.5 mL of ALVAC(2)-NY-ESO-1(M)/TRICOM on Day 1 and 100 μg of the GM-CSF sargramostim on Days 1 through 4 in continuous 28-day cycles for up to 6 cyc...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically documented epithelial carcinoma arising in the ovary, fallopian tube or peritoneum, from stage II-IV at diagnosis, treated with initial surgery and chemotherapy with at least one platinum-based chemotherapy regimen.
- Complete response to frontline therapy as evidenced by negative clinical examination, CA-125 tumor marker, and computed tomography (CT) scan. In addition, if second look surgery was performed (by laparoscopy or laparotomy), the result must have been either negative or microscopic positive. These patients would have normally entered a period of observation after standard management.
- Patients with recurrent disease were eligible if they had completed surgery and/or chemotherapy for recurrent disease and would have normally entered a period of observation after completion of standard management. Eligible patients could have had asymptomatic residual measurable disease on physical examination and/or CT scan, and/or could have had an elevated CA-125 or could have been in complete clinical remission (defined as a serum CA-125 ≤ 35 IU/mL, CT scan without objective evidence of disease, and normal physical examination).
- Tumor expression of 1) NY-ESO-1 by reverse transcription-polymerase chain reaction (RT-PCR) (preferably) or immunohistochemistry (IHC); or 2) LAGE-1 by RT-PCR. Patients whose primary surgery was performed outside the study site were pre-screened and required to release tissue sections or blocks to the study site in order to determine tumor expression of NY-ESO-1 by IHC.
- Expected survival of at least 6 months.
- Full recovery from surgery.
- Karnofsky performance status of 70 or more.
- Laboratory parameters for vital functions were required to be in the normal range. Laboratory abnormalities that were not clinically significant were generally permitted, except for the following laboratory parameters, which were required to be within the ranges specified:
- neutrophil count: ≥ 1.5 × 10\^9/L
- lymphocyte count: ≥ 0.5 × 10\^9/L
- platelet count: ≥ 100 × 10\^9/L
- serum creatinine: ≤ 2 mg/dL
- serum bilirubin (total): ≤ 2 mg/dL
- hemoglobin: ≥ 10 g/dL
- Have been informed of other treatment options.
- Age ≥ 18 years.
- Able and willing to give valid written informed consent.
- Exclusion criteria:
- Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may have been available.
- Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders).
- History of autoimmune disease (e.g., thyroiditis, lupus) except vitiligo.
- Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ.
- Known immunodeficiency or human immunodeficiency virus positivity.
- Known allergy or history of life-threatening reaction to GM-CSF.
- Known allergies to eggs, neomycin, and bovine products, determined by history.
- History of severe allergic reactions to vaccines or unknown allergens.
- Myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, chest pain or shortness of breath with activity, or other heart conditions being treated by a doctor.
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing of study agent.
- Mental impairment that could have compromised the ability to give informed consent and comply with the requirements of the study.
- Lack of availability for immunological and clinical follow-up assessment.
- Previous NY-ESO-1 vaccine therapy.
Exclusion
Key Trial Info
Start Date :
November 14 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2011
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00803569
Start Date
November 14 2008
End Date
January 24 2011
Last Update
October 4 2023
Active Locations (2)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
2
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016