Salvage Ovarian FANG™ Vaccine + Carboplatinum

Gradalis

Status and phase: Completed; Phase 2

Conditions: Stage III Ovarian Cancer; Stage IV Ovarian Cancer

Treatments: Drug: Carboplatinum and Taxol; Drug: Carboplatinum; Biological: Vigil™ Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01867086

CL-PTL 110

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Vigil™ Vaccine

Experimental group

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.

Treatment:

Drug: Carboplatinum and Taxol

Drug: Carboplatinum

Biological: Vigil™ Vaccine