Clinical trial NCT01867086: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stage III Ovarian Cancer
Stage IV Ovarian Cancer
Keywords: ovarian cancer
Lead sponsor: Gradalis, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-03
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time to Progression (TTP)
timeFrame: 24 months
measure: Response Rate
timeFrame: Up to 12 months
Secondary outcomes:
measure: Immune Analysis in Blood
timeFrame: Baseline, End of Treatment (30 days after last dose) up to 12 months
Other outcomes:
measure: Number of Alive Subjects
timeFrame: 24 months
Locations:
city: Dallas
country: United States
facility: Mary Crowley Cancer Research Centers
state: Texas
Study officials:
affiliation: Principal Investigator
name: Minal Barve, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.