Salvage Ovarian FANG™ Vaccine + Bevacizumab

NCT01551745 | Completed Phase 2 Results DMC

• 1 other identifier: CL-PTL 112
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with bevacizumab. All patients will have had Vigil™ prepared and stored from initial primary surgical debulking. Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 4 weeks and bevacizumab 10 mg/kg intravenously every 2 weeks.

Conditions

Stage III Ovarian Cancer; Stage IV Ovarian Cancer

Keywords

Papillary Serous Ovarian Cancer; Endometrioid Ovarian Cancer; Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• Time to Progression

  Time to progression (TTP) following bevacizumab 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 (2)

• Number of Alive Subjects

  24 months

• Enzyme-Linked ImmunoSorbent Spot (ELISPOT)

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

Study Arms (1)

Vigil™ Vaccine

EXPERIMENTAL

Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).

Biological: Vigil™ Vaccine; Drug: Bevacizumab

Interventions

Vigil™ Vaccine BIOLOGICAL

Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).

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

Vigil™ Vaccine

Bevacizumab DRUG

Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.

Also known as: VEGF

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 patients with vaccine prepared for CLPTL 105 but not otherwise qualifying.
• Recurrent cisplatinum resistant/refractory 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 with no intervening therapy.
• 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
• INR \< 1.5
• Baseline blood pressure must be under 140/90

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.
• Major surgery within 6 weeks or minor surgery within 2 weeks of receiving bevacizumab.
• 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 active bleeding or pathologic conditions that carry high risk of bleeding such as a known bleeding disorder, coagulopathy, or tumor involving major blood vessels.
• History of Stroke/Transient Ischemic Attack
• Use of bleeding diathesis
• Use of anti-coagulants
• Patients with clinically significant cardiovascular disease including any of the following:

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; Carcinoma, Ovarian Epithelial

Interventions

Bevacizumab; Vascular Endothelial Growth Factor A

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; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Vascular Endothelial Growth Factors; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors

Results Point of Contact

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

info@gradalisinc.com

2144428124

Study Officials

• Minal Barve, MD

  Mary Crowley Cancer Research Centers

  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: March 1, 2012
• First Posted: March 13, 2012
• Study Start: March 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 19, 2021
• Results First Posted: May 1, 2018

Record last verified: 2021-10

Locations

US (1)