Status:
COMPLETED
Vaccine Therapy in Patients With Stage II, III, or IV Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
Lead Sponsor:
Ludwig Institute for Cancer Research
Collaborating Sponsors:
Roswell Park Cancer Institute
Conditions:
Fallopian Tube Cancer
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This was a Phase 2, single-center, open-label study of recombinant vaccinia-NY-ESO-1 (rV-NY-ESO-1) and recombinant fowlpox-NY-ESO-1 (rF-NY-ESO-1) injections in patients who had a complete response to ...
Detailed Description
Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10\^7 plaque forming units \[PFU\]) on Day 1, followed by monthly subcutaneous injections of rF-NY-ESO-1 (7.41 × 10\^7 PFU) for 6...
Eligibility Criteria
Inclusion
- Histologically documented epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum, from stage II to IV at diagnosis.
- Received initial surgery and chemotherapy with at least one platinum-based chemotherapy regimen.
- Demonstrated complete response to first line therapy as evidenced by negative clinical examination, cancer antigen (CA)-125 tumor marker, and computed tomography (CT) scan. In addition, if second-look surgery was performed, patients must have had no evidence of microscopic or macroscopic disease. Patients must have been within 6 months of completing their first line platinum-based chemotherapy. These patients would normally enter a period of observation as standard management.
- Tumor expression of 1) NY-ESO-1 by reverse transcription-polymerase chain reaction (RT-PCR) analysis, preferably, or immunohistochemistry; or 2) LAGE-1 by RT-PCR.
- Expected survival of at least 6 months.
- Full recovery from surgery.
- Karnofsky performance status of 70% or more.
- Patients must have had the following clinical laboratory results:
- neutrophil count: ≥ 1.5 x 10\^9/L
- lymphocyte count: ≥ 0.5 x 10\^9/L
- platelet count: ≥ 100 x 10\^9/L
- serum creatinine: ≤ 2 mg/dL
- serum bilirubin: ≤ 2 mg/dL
- Ability to avoid close contact with children \< 3 years of age; pregnant or breast feeding women; individuals with active, or a history of, eczema or atopic dermatitis or other skin disorders such as burns, chickenpox, shingles, impetigo, herpes, severe acne, or psoriasis; and immunocompromised individuals (human immunodeficiency virus \[HIV\], leukemia, lymphoma, solid organ transplantation, generalized malignancy, cellular or humoral immunodeficiency syndromes, patients currently receiving cytotoxic chemotherapies, radiation, or high dose corticosteroids).
- Have been informed of other treatment options.
- Age ≥ 18 years.
- Able and willing to give valid written informed consent.
Exclusion
- Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may have been available.
- Other serious illnesses (eg, serious infections requiring antibiotics, bleeding disorders).
- History of current eczema or atopic dermatitis.
- History of autoimmune disease (eg., thyroiditis, lupus).
- Other acute, chronic, or exfoliative skin conditions such as burns, chickenpox, shingles, impetigo, herpes, severe acne, or psoriasis.
- Concomitant systemic treatment with corticosteroids, anti-histamine or non-steroidal anti-inflammatory drugs. Specific cyclooxygenase-2 inhibitors were permitted.
- Chemotherapy, radiation therapy, or immunotherapy within 4 weeks before study entry (6 weeks for nitrosoureas).
- Known HIV positivity.
- Known allergy or severe reaction to a smallpox (vaccinia) vaccination.
- Known allergy to eggs, determined by history.
- 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.
- Presence of 3 or more of the following risk factors:
- Hypertension
- Hypercholesterolemia
- Diabetes
- A first degree relative (for example, mother, father, brother, sister) who had a heart condition before the age of 50
- Current cigarette smoker
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
- Mental impairment that may have compromised the ability to give informed consent and comply with the requirements of the study.
- Lack of availability of a patient for immunological and clinical follow-up assessment.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00112957
Start Date
December 1 2004
End Date
May 1 2009
Last Update
October 4 2023
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001