Salvage Ovarian FANG™ Vaccine + Carboplatinum

NCT01867086 | Completed Phase 2 Results DMC

• 1 other identifier: CL-PTL 110
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage III Ovarian Cancer; Stage IV Ovarian Cancer

Keywords

ovarian cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  24 months

• Response Rate

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

  Up to 12 months

Secondary Outcomes (1)

• Immune Analysis in Blood

  Baseline, End of Treatment (30 days after last dose) up to 12 months

Other Outcomes (1)

• Number of Alive Subjects

  24 months

Study Arms (1)

Vigil™ Vaccine

EXPERIMENTAL

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; Drug: Carboplatinum; Drug: Carboplatinum and Taxol

Interventions

Vigil™ Vaccine BIOLOGICAL

Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks.

Also known as: bi-shRNA furin and GMCSF Augmented Autologous Tumor Cell Vaccine, formerly known as FANG™

Vigil™ Vaccine

Carboplatinum DRUG

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

Carboplatinum and Taxol DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gradalis, Inc.: lead

Study Sites (1)

Mary Crowley Cancer Research Centers

Dallas, Texas, 75230, United States

Location

Related Publications (1)

• 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.

  PMID: 22186789 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Gradalis, Inc.

info@gradalisinc.com

2144428124

Study Officials

• Minal Barve, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 3, 2013
• Study Start: June 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 8, 2016
• Last Updated: June 19, 2018
• Results First Posted: May 1, 2018

Record last verified: 2018-05

Locations

US (1)