Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00803569
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Roswell Park Cancer Institute
New York University Cancer Institute
Information provided by (Responsible Party):
Ludwig Institute for Cancer Research

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Interventions Biological: ALVAC(2)-NY-ESO-1(M)/TRICOM vaccine
Biological: Sargramostim
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ALVAC(2)-NY-ESO-1(M)/TRICOM + GM-CSF
Hide Arm/Group Description Patients received subcutaneous (SC) injections with ALVAC(2)-NY-ESO-1(M)/TRICOM (0.5 mL) on Day 1 and the granulocyte macrophage-colony stimulating factor (GM-CSF) sargramostim (100 μg) on Days 1 through 4 in continuous 28-day cycles for up to 6 cycles.
Period Title: Overall Study
Started 13
Completed 9
Not Completed 4
Reason Not Completed
Progressive Disease             3
Noncompliance             1
Arm/Group Title ALVAC(2)-NY-ESO-1(M)/TRICOM + GM-CSF
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
All enrolled patients.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
57.5  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
13
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
13
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
13
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
 100.0%
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 13 participants
25.7  (5.2)
1.Primary Outcome
Title Number of Patients With Treatment-emergent Adverse Events
Hide Description 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.
Time Frame Continuously for up to 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received at least 1 dose of study drug.
Arm/Group Title ALVAC(2)-NY-ESO-1(M)/TRICOM + GM-CSF
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
12
  92.3%
Maximum Grade 1 TEAE
6
  46.2%
Maximum Grade 2 TEAE
6
  46.2%
Treatment-related TEAE
12
  92.3%
SeriousTEAE
0
   0.0%
Death
0
   0.0%
TEAE Leading to Discontinuation
0
   0.0%
2.Secondary Outcome
Title Number of Patients With Best Overall Tumor Response
Hide Description Tumor responses were evaluated using computed tomography and categorized according to the Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0) at baseline, at Week 12 (± 28 days), and at Week 24 (end of study). Per RECIST, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions [no evidence of disease]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.
Time Frame Baseline and Weeks 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with data available from at least 1 post-baseline response assessment. One patient discontinued the study prior to the Week 12 response assessment.
Arm/Group Title ALVAC(2)-NY-ESO-1(M)/TRICOM + GM-CSF
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
No evidence of disease
10
  83.3%
Progressive disease
2
  16.7%
3.Secondary Outcome
Title Median Progression-free Survival (PFS)
Hide Description PFS was calculated from the date of the first dose of study drug to the date of documented progression or death, whichever occurred first. Patients without disease progression or death had their observation time censored at the date of the last valid disease assessment. PFS was summarized using Kaplan-Meier product-limit estimators.
Time Frame Baseline and up to approximately 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with data available from at least 1 post-baseline response assessment. One patient discontinued the study prior to the Week 12 response assessment.
Arm/Group Title ALVAC(2)-NY-ESO-1(M)/TRICOM + GM-CSF
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 12
Median (Full Range)
Unit of Measure: days
167.5
(81 to 177)
4.Secondary Outcome
Title Median Cancer Antigen 25 (CA-125) Values on Study
Hide Description Blood samples were collected for CA-125 testing as a component of disease evaluations at Baseline and Weeks 8, 12, 16, 20, and 24 (end of study) or every 2 to 3 months on study according to standard institutional practice.
Time Frame Baseline through Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with data available from at least 1 post-baseline response assessment. One patient discontinued the study prior to the Week 12 response assessment.
Arm/Group Title ALVAC(2)-NY-ESO-1(M)/TRICOM + GM-CSF
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 12
Median (Full Range)
Unit of Measure: U/mL
Baseline
8.6
(2.6 to 386.5)
Week 8
9.7
(2.7 to 935.2)
Week 12
7.4
(2.0 to 366.6)
Week 16
9.4
(2.0 to 389.1)
Week 20
9.0
(2.0 to 1181.1)
Week 24
8.0
(2.8 to 1587.7)
5.Secondary Outcome
Title Number of Patients With NY-ESO-1 and LAGE-1 Antigen Positivity
Hide Description Blood samples were collected for measurement of NY-ESO-1 and LAGE-1 antigen positivity at Baseline and Weeks 4, 8 ,12, 16, 20, and 24 (end of study). Antibody testing was performed by enzyme-linked immunosorbent assay (ELISA).
Time Frame Baseline through Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with data available from at least 1 post-baseline response assessment. One patient discontinued the study prior to the Week 12 response assessment.
Arm/Group Title ALVAC(2)-NY-ESO-1(M)/TRICOM + GM-CSF
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
NY-ESO-1: BL positive, Post-BL positive
2
  16.7%
NY-ESO-1: BL negative, Post-BL positive
10
  83.3%
LAGE-1: BL positive, Post-BL positive
1
   8.3%
LAGE-1: BL negative, Post-BL positive
3
  25.0%
LAGE-1: BL negative, Post-BL negative
2
  16.7%
LAGE-1: Not evaluable
6
  50.0%
Time Frame All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 26 weeks.
Adverse Event Reporting Description AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a “possible”, “probable”, or “definite” relationship to study drug; preferred terms were counted only once per patient at the maximum reported grade.
 
Arm/Group Title ALVAC(2)-NY-ESO-1(M)/TRICOM + GM-CSF
Hide Arm/Group Description 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.
All-Cause Mortality
ALVAC(2)-NY-ESO-1(M)/TRICOM + GM-CSF
Affected / at Risk (%)
Total   0/13 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
ALVAC(2)-NY-ESO-1(M)/TRICOM + GM-CSF
Affected / at Risk (%)
Total   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ALVAC(2)-NY-ESO-1(M)/TRICOM + GM-CSF
Affected / at Risk (%)
Total   12/13 (92.31%) 
Cardiac disorders   
Palpitations  1  1/13 (7.69%) 
Gastrointestinal disorders   
Abdominal pain  1  1/13 (7.69%) 
Flatulence  1  1/13 (7.69%) 
Nausea  1  1/13 (7.69%) 
Oral pain  1  1/13 (7.69%) 
General disorders   
Injection site pain  1  8/13 (61.54%) 
Injection site erythema  1  7/13 (53.85%) 
Injection site reaction  1  6/13 (46.15%) 
Fatigue  1  5/13 (38.46%) 
Injection site induration  1  4/13 (30.77%) 
Injection site pruritus  1  2/13 (15.38%) 
Injection site rash  1  2/13 (15.38%) 
Chills  1  1/13 (7.69%) 
Hypothermia  1  1/13 (7.69%) 
Influenza-like illness  1  1/13 (7.69%) 
Injection site nodule  1  1/13 (7.69%) 
Injection site swelling  1  1/13 (7.69%) 
Oedema  1  1/13 (7.69%) 
Oedema peripheral  1  1/13 (7.69%) 
Infections and infestations   
Vaginal infection  1  2/13 (15.38%) 
Acute sinusitis  1  1/13 (7.69%) 
Nasopharyngitis  1  1/13 (7.69%) 
Rhinitis  1  1/13 (7.69%) 
Injury, poisoning and procedural complications   
Contusion  1  1/13 (7.69%) 
Investigations   
Skin test positive  1  1/13 (7.69%) 
Metabolism and nutrition disorders   
Anorexia  1  1/13 (7.69%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1  4/13 (30.77%) 
Back pain  1  2/13 (15.38%) 
Arthralgia  1  1/13 (7.69%) 
Nervous system disorders   
Headache  1  5/13 (38.46%) 
Dizziness  1  1/13 (7.69%) 
Reproductive system and breast disorders   
Vulvovaginal pruritus  1  1/13 (7.69%) 
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal pain  1  2/13 (15.38%) 
Cough  1  1/13 (7.69%) 
Nasal congestion  1  1/13 (7.69%) 
Skin and subcutaneous tissue disorders   
Pruritus  1  4/13 (30.77%) 
Ecchymosis  1  1/13 (7.69%) 
Erythema  1  1/13 (7.69%) 
Rash  1  1/13 (7.69%) 
Rash pruritic  1  1/13 (7.69%) 
Vascular disorders   
Flushing  1  1/13 (7.69%) 
1
Term from vocabulary, MedDRA 13.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mary Macri, Director, Clinical Trials Management
Organization: Ludwig Institute for Cancer Research
Phone: (212) 450-1546
EMail: mmacri@licr.org
Layout table for additonal information
Responsible Party: Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier: NCT00803569     History of Changes
Other Study ID Numbers: LUD2007-005
CDR0000628730 ( Other Identifier: Ludwig )
First Submitted: December 4, 2008
First Posted: December 5, 2008
Results First Submitted: January 3, 2018
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019