Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Active	18 and over	NCI	RPCI-I-125207 I 125207, LUDWIG-LUD2007-005, NCT00803569

Objectives

Primary

1. 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

1. Determine the tumor response in patients treated with this regimen.
2. Determine the immune response in patients treated with this regimen.

Entry 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

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

Patient Characteristics:

• Karnofsky performance status ≥ 70%
• Life expectancy ≥ 6 months
• ANC ≥ 1,500/mm³
• WBC ≥ 5,000/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

Outcomes

Safety and tolerability as assessed by NCI CTCAE v3.0

Tumor response as assessed by RECIST criteria
Immune response (humoral and cellular immunity)

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.

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Adekunle Odunsi, MD, PhD, Protocol chair		Ph: 716-845-8376; 800-685-6825 Email: kunle.odunsi@roswellpark.org

U.S.A.
New York
	Buffalo
	Roswell Park Cancer Institute
		Clinical Trials Office - Roswell Park Cancer Institute	Ph:  877-275-7724
	New York
	NYU Cancer Institute at New York University Medical Center
		Nina Bhardwaj, MD	Ph:  212-263-6485

Registry Information
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
Trial Start Date		2008-11-03
Trial Completion Date		2011-02-19 (estimated)
Registered in ClinicalTrials.gov		NCT00803569
Date Submitted to PDQ		2008-11-21
Information Last Verified		2009-11-30
NCI Grant/Contract Number		CA16056

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