Vaccine Therapy in Stage II, III, or IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers

NCT00803569 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: LUD2007-005CDR0000628730
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

This was a Phase 1, non-randomized, open-label, multicenter study of the ALVAC(2)-NY-ESO-1(M)/TRICOM vaccine administered with the granulocyte macrophage-colony stimulating factor (GM-CSF) sargramostim in patients with NY-ESO-1- or LAGE-1-positive epithelial ovarian, fallopian tube, or primary peritoneal cavity cancers who had completed standard therapy for primary or recurrent disease and would have normally entered a period of observation. The primary study objective was to determine the safety and tolerability of study vaccination, with secondary objectives including the determination of clinical and immunological responses.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Treatment-emergent Adverse Events

  Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period.

  Continuously for up to 26 weeks

Secondary Outcomes (4)

• Number of Patients With Best Overall Tumor Response

  Baseline and Weeks 12 and 24

• Median Progression-free Survival (PFS)

  Baseline and up to approximately 24 weeks

• Median Cancer Antigen 25 (CA-125) Values on Study

  Baseline through Week 24

• Number of Patients With NY-ESO-1 and LAGE-1 Antigen Positivity

  Baseline through Week 24

Study Arms (1)

ALVAC(2)-NY-ESO-1(M)/TRICOM + GM-CSF

EXPERIMENTAL

Patients received SC injections with ALVAC(2)-NY-ESO-1(M)/TRICOM (0.5 mL) on Day 1 and the GM-CSF sargramostim (100 μg) on Days 1 through 4 in continuous 28-day cycles for up to 6 cycles.

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

Interventions

ALVAC(2)-NY-ESO-1(M)/TRICOM vaccine BIOLOGICAL

The vaccine comprises the modified canary pox vector, ALVAC(2), inserted with the following genes: NYESO-1(M), TRICOM (LFA-3, ICAM-1, B7.1), vvE3L, vvK3L. The vaccine is administered at a dose of 0.5 mL SC.

ALVAC(2)-NY-ESO-1(M)/TRICOM + GM-CSF

Sargramostim BIOLOGICAL

The GM-CSF sargramostim is administered at a dose of 100 μg SC.

ALVAC(2)-NY-ESO-1(M)/TRICOM + GM-CSF

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically documented epithelial carcinoma arising in the ovary, fallopian tube or peritoneum, from stage II-IV at diagnosis, treated with initial surgery and chemotherapy with at least one platinum-based chemotherapy regimen.
• Complete response to frontline therapy as evidenced by negative clinical examination, CA-125 tumor marker, and computed tomography (CT) scan. In addition, if second look surgery was performed (by laparoscopy or laparotomy), the result must have been either negative or microscopic positive. These patients would have normally entered a period of observation after standard management.
• Patients with recurrent disease were eligible if they had completed surgery and/or chemotherapy for recurrent disease and would have normally entered a period of observation after completion of standard management. Eligible patients could have had asymptomatic residual measurable disease on physical examination and/or CT scan, and/or could have had an elevated CA-125 or could have been in complete clinical remission (defined as a serum CA-125 ≤ 35 IU/mL, CT scan without objective evidence of disease, and normal physical examination).
• Tumor expression of 1) NY-ESO-1 by reverse transcription-polymerase chain reaction (RT-PCR) (preferably) or immunohistochemistry (IHC); or 2) LAGE-1 by RT-PCR. Patients whose primary surgery was performed outside the study site were pre-screened and required to release tissue sections or blocks to the study site in order to determine tumor expression of NY-ESO-1 by IHC.
• Expected survival of at least 6 months.
• Full recovery from surgery.
• Karnofsky performance status of 70 or more.
• Laboratory parameters for vital functions were required to be in the normal range. Laboratory abnormalities that were not clinically significant were generally permitted, except for the following laboratory parameters, which were required to be within the ranges specified:
• neutrophil count: ≥ 1.5 × 10\^9/L
• lymphocyte count: ≥ 0.5 × 10\^9/L
• platelet count: ≥ 100 × 10\^9/L
• serum creatinine: ≤ 2 mg/dL
• serum bilirubin (total): ≤ 2 mg/dL
• hemoglobin: ≥ 10 g/dL
• Have been informed of other treatment options.

You may not qualify if:

• Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may have been available.
• Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders).
• History of autoimmune disease (e.g., thyroiditis, lupus) except vitiligo.
• Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ.
• Known immunodeficiency or human immunodeficiency virus positivity.
• Known allergy or history of life-threatening reaction to GM-CSF.
• Known allergies to eggs, neomycin, and bovine products, determined by history.
• History of severe allergic reactions to vaccines or unknown allergens.
• Myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, chest pain or shortness of breath with activity, or other heart conditions being treated by a doctor.
• Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing of study agent.
• Mental impairment that could have compromised the ability to give informed consent and comply with the requirements of the study.
• Lack of availability for immunological and clinical follow-up assessment.
• Previous NY-ESO-1 vaccine therapy.

Sponsors & Collaborators

• Ludwig Institute for Cancer Research: lead
• Roswell Park Cancer Institute: collaborator
• New York University Cancer Institute: collaborator

Study Sites (2)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

NYU Cancer Institute at New York University Medical Center

New York, New York, 10016, United States

Location

Related Publications (1)

• Withers HG, Matsuzaki J, Long M, Rosario SR, Chodon T, Tsuji T, Koya R, Yan L, Wang J, Keler T, Lele SB, Zsiros E, Lugade A, Hutson A, Blank S, Bhardwaj N, Shrikant P, Liu S, Odunsi K. mTOR inhibition modulates vaccine-induced immune responses to generate memory T cells in patients with solid tumors. J Immunother Cancer. 2025 Mar 25;13(3):e010408. doi: 10.1136/jitc-2024-010408.

  PMID: 40132910 DERIVED

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

sargramostim

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Jonathan Skipper PhD
• Organization: Ludwig Institute for Cancer Research

jskipper@lcr.org

12124501539

Study Officials

• Kunle Odunsi, MD, PhD

  Roswell Park Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients received the same study treatment.

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: November 14, 2008
• Primary Completion: January 24, 2011
• Study Completion: January 24, 2011
• Last Updated: October 4, 2023
• Results First Posted: February 15, 2019

Record last verified: 2022-10

Locations

US (2)