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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

Phase 1
18 Years
Not Enrolling
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Thank you

Trial Information

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



- 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.


- 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.

Inclusion Criteria


- 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

- No CNS metastases


- 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

- 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


- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability as assessed by NCI CTCAE v3.0

Safety Issue:


Principal Investigator

Adekunle O. Odunsi, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

November 2008

Completion Date:

June 2011

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • 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
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial



Roswell Park Cancer InstituteBuffalo, New York  14263
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016