Status:
COMPLETED
Salvage Ovarian FANG™ Vaccine + Carboplatinum
Lead Sponsor:
Gradalis, Inc.
Conditions:
Stage III Ovarian Cancer
Stage IV Ovarian Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 prima...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2016
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01867086
Start Date
June 1 2013
End Date
April 8 2016
Last Update
June 19 2018
Active Locations (1)
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1
Mary Crowley Cancer Research Centers
Dallas, Texas, United States, 75230