Salvage Ovarian FANG™ Vaccine + Carboplatinum

Completed · Phase 2

Conditions studied: Stage III Ovarian Cancer, Stage IV Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT01867086

Run by

Gradalis, Inc.

People needed

1

Starts

2013-06-01

Expected to finish

2016-04-08

Last updated by the study team

2018-06-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Mary Crowley Cancer Research Centers — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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