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(s) targeted: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Intervention: ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine (Biological); sargramostim (Biological)

Phase: Phase 1

Status: Recruiting

Sponsored by: Roswell Park Cancer Institute

Official(s) and/or principal investigator(s):
Adekunle O. Odunsi, MD, PhD, Study Chair, Affiliation: Roswell Park Cancer Institute

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.

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

Study design: Treatment, Non-Randomized, Open Label

Primary outcome: Safety and tolerability as assessed by NCI CTCAE v3.0

Secondary outcome:

Tumor response as assessed by RECIST criteria

Immune response (humoral and cellular immunity)

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

NYU Cancer Institute at New York University Medical Center, New York, New York 10016, United States; Recruiting
Nina Bhardwaj, MD, Phone: 212-263-6485

Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States; Recruiting
Clinical Trials Office - Roswell Park Cancer Institute, Phone: 877-275-7724

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: November 2008
Last updated: June 9, 2009