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Salvage Ovarian FANG™ Vaccine + Carboplatinum

Primary Purpose

Stage III Ovarian Cancer, Stage IV Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vigil™ Vaccine
Carboplatinum
Carboplatinum and Taxol
Sponsored by
Gradalis, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage III Ovarian Cancer focused on measuring ovarian cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically confirmed papillary serous or endometrioid ovarian cancer.
  2. Previous randomization to Gradalis, Inc. protocol CL-PTL 105; observation arm (Group B) or or patients with vaccine prepared for CL-PTL 105 but did not otherwise qualify.
  3. 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.
  4. Successful manufacturing of 4 vials of Vigil™ vaccine.
  5. Recovered from all clinically relevant toxicities related to prior therapies.
  6. ECOG PS 0-2 prior to Vigil™ vaccine administration.

  7. Normal organ and marrow function as defined below:

    1. Absolute granulocyte count ≥ 1,500/mm3
    2. Absolute lymphocyte count ≥ 200/mm3
    3. Platelets ≥ 100,000/mm3
    4. Total bilirubin ≤ 1.5 x ULN
    5. AST(SGOT)/ALT(SGPT)/alkaline phosphatase ≤ 2.5 x ULN
    6. Creatinine < 1.5 mg/dL
  8. Patients must be off all "statin" drugs for ≥ 2 weeks prior to initiation of therapy.
  9. 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.

Sites / Locations

  • Mary Crowley Cancer Research Centers

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vigil™ Vaccine

Arm 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.

Outcomes

Primary Outcome Measures

Time to Progression (TTP)
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.
Response Rate
Response will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline.

Secondary Outcome Measures

Immune Analysis in Blood
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.

Full Information

First Posted
May 29, 2013
Last Updated
May 21, 2018
Sponsor
Gradalis, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01867086
Brief Title
Salvage Ovarian FANG™ Vaccine + Carboplatinum
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 Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 8, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gradalis, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage III Ovarian Cancer, Stage IV Ovarian Cancer
Keywords
ovarian cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vigil™ Vaccine
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
Vigil™ Vaccine
Other Intervention Name(s)
bi-shRNA furin and GMCSF Augmented Autologous Tumor Cell Vaccine, formerly known as FANG™
Intervention Description
Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Carboplatinum
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Carboplatinum and Taxol
Intervention 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.
Primary Outcome Measure Information:
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
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
Secondary Outcome Measure Information:
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
Other Pre-specified Outcome Measures:
Title
Number of Alive Subjects
Description
Survival status of patients after treatment will be determined.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed papillary serous or endometrioid ovarian cancer. Previous randomization to Gradalis, Inc. protocol CL-PTL 105; observation arm (Group B) or or patients with vaccine prepared for CL-PTL 105 but did not otherwise qualify. 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. Successful manufacturing of 4 vials of Vigil™ vaccine. Recovered from all clinically relevant toxicities related to prior therapies. ECOG PS 0-2 prior to Vigil™ vaccine administration. Normal organ and marrow function as defined below: Absolute granulocyte count ≥ 1,500/mm3 Absolute lymphocyte count ≥ 200/mm3 Platelets ≥ 100,000/mm3 Total bilirubin ≤ 1.5 x ULN AST(SGOT)/ALT(SGPT)/alkaline phosphatase ≤ 2.5 x ULN Creatinine < 1.5 mg/dL Patients must be off all "statin" drugs for ≥ 2 weeks prior to initiation of therapy. Ability to understand and the willingness to sign a written informed protocol specific consent. Exclusion Criteria: 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. Patient must not have received any other investigational agents within 4 weeks prior to study entry. Patients who require parenteral hydration of nutrition and have evidence of partial bowel obstruction or perforation. Patients with history of brain metastases. Patients with compromised pulmonary disease. 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. Prior splenectomy. Prior malignancy (excluding nonmelanoma carcinomas of the skin and carcinoma in situ cervix) unless in remission for ≥ 2 years. Kaposi's Sarcoma. Patients with peripheral neuropathy ≥2 (paclitaxel). Uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements. Patients with known HIV. Patients with chronic Hepatitis B and C infection. Patients with uncontrolled autoimmune diseases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minal Barve, MD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mary Crowley Cancer Research Centers
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22186789
Citation
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.
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Salvage Ovarian FANG™ Vaccine + Carboplatinum

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