Salvage Ovarian FANG™ Vaccine + Carboplatinum

• Sponsor: Gradalis, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01867086
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Arm: 1
• Duration (Months): 34.2
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with carboplatinum. All patients will have Vigil™ prepared and stored from ovarian tumor cells obtained at the time of primary surgical debulking. Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2/3 hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection, once every 3 weeks.

Condition or Disease	Intervention/Treatment	Phase
Stage III Ovarian Cancer; Stage IV Ovarian Cancer	Biological: Vigil™ Vaccine; Drug: Carboplatinum; Drug: Carboplatinum and Taxol	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of Adjuvant Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine (FANG™) Integrated With Chemotherapy for Patients With Recurrent Cisplatinum Sensitive Ovarian Cancer Participating in Study CL-PTL 105
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Apr 8, 2016

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Vigil™ Vaccine Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone.

Biological: Vigil™ Vaccine; Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks.; Other Names: bi-shRNA furin and GMCSF Augmented Autologous Tumor Cell Vaccine formerly known as FANG™ ; Drug: Carboplatinum; Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone.; Drug: Carboplatinum and Taxol; Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone.

Outcome Measures

Primary Outcome Measures

1. Time to Progression (TTP) [24 months]

   Time to progression (TTP) will be determined following Carboplatinum integrated with Vigil vaccine in patients failing standard of care in study CL-PTL 105 or in those not otherwise qualifying after vaccine production. This will be measured from the treatment start date (date of first dose) to either the date the patient is first recorded as having disease recurrence (even if the patient went off treatment because of toxicity), or the date of death if the patient dies due to any causes before progression.

2. Response Rate [Up to 12 months]

   Response will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline.

Secondary Outcome Measures

1. Immune Analysis in Blood [Baseline, End of Treatment (30 days after last dose) up to 12 months]

   To determine if subjects will have a positive (defined as >10 ELISPOTS from baseline) immune response to Vigil. Blood was collected to compare ELISPOT results from baseline until 30 days after last dose.

Other Outcome Measures

1. Number of Alive Subjects [24 months]

   Survival status of patients after treatment will be determined.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Histologically confirmed papillary serous or endometrioid ovarian cancer.

2. Previous randomization to Gradalis, Inc. protocol CL-PTL 105; observation arm (Group

1. or or patients with vaccine prepared for CL-PTL 105 but did not otherwise qualify.

1. Recurrent cisplatinum-sensitive disease (defined as the appearance of any measurable or evaluable lesion or as asymptomatic CA-125 levels greater than 100 u/mL at two consecutive measurements after a 6 month period after platinum treatment.

2. Successful manufacturing of 4 vials of Vigil™ vaccine.

3. Recovered from all clinically relevant toxicities related to prior therapies.

4. ECOG PS 0-2 prior to Vigil™ vaccine administration.

5. Normal organ and marrow function as defined below:

6. Absolute granulocyte count ≥ 1,500/mm3

7. Absolute lymphocyte count ≥ 200/mm3

8. Platelets ≥ 100,000/mm3

9. Total bilirubin ≤ 1.5 x ULN

10. AST(SGOT)/ALT(SGPT)/alkaline phosphatase ≤ 2.5 x ULN

11. Creatinine < 1.5 mg/dL

12. Patients must be off all "statin" drugs for ≥ 2 weeks prior to initiation of therapy.

13. Ability to understand and the willingness to sign a written informed protocol specific consent.

Exclusion Criteria:

1. Surgery involving general anesthesia, chemotherapy, radiotherapy, steroid therapy, or immunotherapy within 4 weeks prior to vaccination. Chemotherapy within 3 weeks prior to vaccination. Steroid therapy within 1 week prior to vaccination.

2. Patient must not have received any other investigational agents within 4 weeks prior to study entry.

3. Patients who require parenteral hydration of nutrition and have evidence of partial bowel obstruction or perforation.

4. Patients with history of brain metastases.

5. Patients with compromised pulmonary disease.

6. Short term (<30 days) concurrent systemic steroids ≤ 0.25 mg/kg prednisone per day (maximum 7.5 mg/day) and bronchodilators (inhaled steroids) are permitted; other steroid regimens and/or immunosuppressives are excluded.

7. Prior splenectomy.

8. Prior malignancy (excluding nonmelanoma carcinomas of the skin and carcinoma in situ cervix) unless in remission for ≥ 2 years.

9. Kaposi's Sarcoma.

10. Patients with peripheral neuropathy ≥2 (paclitaxel).

11. Uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements.

12. Patients with known HIV.

13. Patients with chronic Hepatitis B and C infection.

14. Patients with uncontrolled autoimmune diseases.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mary Crowley Cancer Research Centers	Dallas	Texas	United States	75230

Sponsors and Collaborators

• Gradalis, Inc.

Investigators

• Principal Investigator: Minal Barve, MD, Principal Investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

• Senzer N, Barve M, Kuhn J, Melnyk A, Beitsch P, Lazar M, Lifshitz S, Magee M, Oh J, Mill SW, Bedell C, Higgs C, Kumar P, Yu Y, Norvell F, Phalon C, Taquet N, Rao DD, Wang Z, Jay CM, Pappen BO, Wallraven G, Brunicardi FC, Shanahan DM, Maples PB, Nemunaitis J. Phase I trial of "bi-shRNAi(furin)/GMCSF DNA/autologous tumor cell" vaccine (FANG) in advanced cancer. Mol Ther. 2012 Mar;20(3):679-86. doi: 10.1038/mt.2011.269. Epub 2011 Dec 20.

• Responsible Party: Gradalis, Inc.
• ClinicalTrials.gov Identifier: NCT01867086
• Other Study ID Numbers: CL-PTL 110
• First Posted: Jun 3, 2013
• Last Update Posted: Jun 19, 2018
• Last Verified: May 1, 2018

• Keywords provided by Gradalis, Inc.: ovarian cancer
• Additional relevant MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Carboplatin; Vaccines

Study Results

Participant Flow

Recruitment Details	This study recruited subjects from CL-PTL-105 who recurred and were either randomized to the control/observation arm (Group B) or screen-failed but had successful manufacturing of Vigil (minimum of 4 doses).
Pre-assignment Detail	1 subject was enrolled and administered Vigil plus Carboplatinum. This subject did not complete treatment due to disease progression.

Arm/Group Title	Vigil™ Vaccine
Arm/Group Description	Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone. Vigil™ Vaccine: Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks. Carboplatinum: Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion)
Period Title: Overall Study
STARTED	1
COMPLETED	0
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Vigil™ Vaccine
Arm/Group Description	Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks.
Overall Participants	1
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	0 0%
>=65 years	1 100%
Sex: Female, Male (Count of Participants)
Female	1 100%
Male	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	1 100%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Time to Progression (TTP)
Description	Time to progression (TTP) will be determined following Carboplatinum integrated with Vigil vaccine in patients failing standard of care in study CL-PTL 105 or in those not otherwise qualifying after vaccine production. This will be measured from the treatment start date (date of first dose) to either the date the patient is first recorded as having disease recurrence (even if the patient went off treatment because of toxicity), or the date of death if the patient dies due to any causes before progression.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

1 subject was enrolled and started Vigil treatment plus Carboplatinum. This subject did not complete treatment due to disease progression. There is no Outcome Measure Data table because Time to Progression (TTP) and Response Rate (RR) were not collected and analyzed. This study was terminated.

Arm/Group Title	Vigil™ Vaccine
Arm/Group Description	Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone. Vigil™ Vaccine: Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks. Carboplatinum: Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion)
Measure Participants	0

2. Primary Outcome

Title	Response Rate
Description	Response will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

1 subject was enrolled and started Vigil treatment plus Carboplatinum. This subject did not complete treatment due to disease progression. There is no Outcome Measure Data table because Time to Progression (TTP) and Response Rate (RR) were not collected and analyzed. This study was terminated.

Arm/Group Title	Vigil™ Vaccine
Arm/Group Description	Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone. Vigil™ Vaccine: Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks. Carboplatinum: Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion)
Measure Participants	0

3. Secondary Outcome

Title	Immune Analysis in Blood
Description	To determine if subjects will have a positive (defined as >10 ELISPOTS from baseline) immune response to Vigil. Blood was collected to compare ELISPOT results from baseline until 30 days after last dose.
Time Frame	Baseline, End of Treatment (30 days after last dose) up to 12 months

Outcome Measure Data

Analysis Population Description

1 subject was enrolled and started Vigil treatment plus Carboplatinum. This subject did not complete treatment due to disease progression. After 12 months, subject had positive ELISPOT response. Statistical analysis was not done. This study was terminated.

Arm/Group Title	Vigil™ Vaccine
Arm/Group Description	Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone. Vigil™ Vaccine: Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks. Carboplatinum: Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion)
Measure Participants	1
ELISPOT-Positive After 12 months	1 100%
ELISPOT-Negative After 12 months	0 0%

4. Other Pre-specified Outcome

Title	Number of Alive Subjects
Description	Survival status of patients after treatment will be determined.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

1 subject was enrolled and started Vigil treatment plus Carboplatinum. This subject did not complete treatment due to disease progression. After 24 months, subject was not alive. Statistical analysis was not done. This study was terminated.

Arm/Group Title	Vigil™ Vaccine
Arm/Group Description	Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone. Vigil™ Vaccine: Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks. Carboplatinum: Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion)
Measure Participants	1
Alive Subjects After 24 months	0 0%
Dead Subjects After 24 months	1 100%

Adverse Events

Arm/Group Title	Vigil™ Vaccine
Arm/Group Description	Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks.
All Cause Mortality
	Vigil™ Vaccine
	Affected / at Risk (%)	# Events
Total	1/1 (100%)
Serious Adverse Events
	Vigil™ Vaccine
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Other (Not Including Serious) Adverse Events
	Vigil™ Vaccine
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
General disorders
Injection Site Reaction	0/1 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

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.