Salvage Ovarian FANG™ Vaccine + Carboplatinum

Launched by GRADALIS, INC. · May 29, 2013

Keywords

ClinConnect Summary

No description provided

Gender

ALL

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.