Salvage Ovarian FANG™ Vaccine + Carboplatinum
Condition: Stage III Ovarian Cancer; Stage IV Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Vigil™ Vaccine; Carboplatinum; Carboplatinum and Taxol
Intervention description: Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks.; 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.; 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.
Intervention MeSH terms: Carboplatin; Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ovarian cancer

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.