Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Ludwig Institute for Cancer Research

Adekunle Omotayo Odunsi

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00803569
Information obtained from ClinicalTrials.gov on December 14, 2011

Back to Top