Vaccine Therapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
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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 |
- 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 ]
- 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) |
-
Biological: fowlpox-NY-ESO-1 vaccine
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 |
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| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| 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 May 23, 2013