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

NCT00112957 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: LUD 2002-012RPCI-I-13303CDR0000424461
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This was a Phase 2, single-center, open-label study of recombinant vaccinia-NY-ESO-1 (rV-NY-ESO-1) and recombinant fowlpox-NY-ESO-1 (rF-NY-ESO-1) injections in patients who had a complete response to standard therapy for epithelial ovarian, fallopian tube, or primary peritoneal carcinoma and whose tumors expressed NY-ESO-1 or LAGE-1 antigen. Study objectives were to evaluate maintenance of remission at 12 months, time to failure of vaccine therapy, cellular and humoral immunity and any correlation with time to failure, and safety.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Keywords

fallopian tube cancer; stage II ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; peritoneal cavity cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients in Remission at 1 Year

  Time to failure (TTF) was evaluated as the crude proportion of patients in remission at 1 year, calculated as: 100 x (number of patients in remission at 1 year)/(number of patients with known status at 1 year). The Kaplan-Meier cumulative estimate of the proportion of patients in remission at 1 year was also calculated.

  12 months

Secondary Outcomes (8)

• Mean Time to Failure Among Patients Who Progressed On Study

  Up to 20 months

• Number of Patients With Best Overall Tumor Response

  Up to 20 months

• Mean Absolute Cancer Antigen-125 Values Over Time on Study

  Up to 20 months

• Number of Patients With NY-ESO-1 and LAGE-1-specific Immunity

  Up to 20 months

• Number of Patients With Release of Interferon-Gamma by T Cells in Response to Cancer Antigens

  Up to 20 months

Study Arms (1)

rV- and rF-NY-ESO-1

EXPERIMENTAL

Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10\^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10\^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.

Biological: rV-NY-ESO-1 vaccine; Biological: rF-NY-ESO-1 vaccine

Interventions

rV-NY-ESO-1 vaccine BIOLOGICAL

Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10\^7 PFU) on Day 1.

rV- and rF-NY-ESO-1

rF-NY-ESO-1 vaccine BIOLOGICAL

Patients received subcutaneous injections of rF-NY-ESO-1 (7.41 × 10\^7 PFU) on Days 29, 57, 85, 113, 141, and 169.

rV- and rF-NY-ESO-1

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 to IV at diagnosis.
• Received initial surgery and chemotherapy with at least one platinum-based chemotherapy regimen.
• Demonstrated complete response to first line therapy as evidenced by negative clinical examination, cancer antigen (CA)-125 tumor marker, and computed tomography (CT) scan. In addition, if second-look surgery was performed, patients must have had no evidence of microscopic or macroscopic disease. Patients must have been within 6 months of completing their first line platinum-based chemotherapy. These patients would normally enter a period of observation as standard management.
• Tumor expression of 1) NY-ESO-1 by reverse transcription-polymerase chain reaction (RT-PCR) analysis, preferably, or immunohistochemistry; or 2) LAGE-1 by RT-PCR.
• Expected survival of at least 6 months.
• Full recovery from surgery.
• Karnofsky performance status of 70% or more.
• Patients must have had the following clinical laboratory results:
• neutrophil count: ≥ 1.5 x 10\^9/L
• lymphocyte count: ≥ 0.5 x 10\^9/L
• platelet count: ≥ 100 x 10\^9/L
• serum creatinine: ≤ 2 mg/dL
• serum bilirubin: ≤ 2 mg/dL
• Ability to avoid close contact with children \< 3 years of age; pregnant or breast feeding women; individuals with active, or a history of, eczema or atopic dermatitis or other skin disorders such as burns, chickenpox, shingles, impetigo, herpes, severe acne, or psoriasis; and immunocompromised individuals (human immunodeficiency virus \[HIV\], leukemia, lymphoma, solid organ transplantation, generalized malignancy, cellular or humoral immunodeficiency syndromes, patients currently receiving cytotoxic chemotherapies, radiation, or high dose corticosteroids).
• 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 (eg, serious infections requiring antibiotics, bleeding disorders).
• History of current eczema or atopic dermatitis.
• History of autoimmune disease (eg., thyroiditis, lupus).
• Other acute, chronic, or exfoliative skin conditions such as burns, chickenpox, shingles, impetigo, herpes, severe acne, or psoriasis.
• Concomitant systemic treatment with corticosteroids, anti-histamine or non-steroidal anti-inflammatory drugs. Specific cyclooxygenase-2 inhibitors were permitted.
• Chemotherapy, radiation therapy, or immunotherapy within 4 weeks before study entry (6 weeks for nitrosoureas).
• Known HIV positivity.
• Known allergy or severe reaction to a smallpox (vaccinia) vaccination.
• Known allergy to eggs, determined by history.
• 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.
• Presence of 3 or more of the following risk factors:
• Hypertension
• Hypercholesterolemia
• Diabetes

Sponsors & Collaborators

• Ludwig Institute for Cancer Research: lead
• Roswell Park Cancer Institute: collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2005
• First Posted: June 3, 2005
• Study Start: December 1, 2004
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: October 4, 2023
• Results First Posted: March 19, 2018

Record last verified: 2023-10

Locations

US (1)