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Phase III Trial of Maintenance FANG™ for High Risk Stage III/IV Ovarian Cancer
Overall Recruitment Status: Active, currently enrolling
 
Official Title
Double-Blind, Placebo Controlled Phase III Trial of Maintenance FANG™ (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) for High Risk Stage III/IV Ovarian Cancer
 
Region Sponsors
California - Southern
Gradalis, Inc.
 
Acronym KP IRB No.
10638
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Females with Ovarian Cancer; Ovarian Neoplasms
 
Purpose
This is a multicenter, randomized, double-blind, placebo-controlled, Phase III study of maintenance FANG in women with Stages III/IV high-grade serous / endometrioid ovarian, fallopian tube or primary peritoneal cancer who have achieved a clinically defined complete response following primary surgery and adjuvant chemotherapy. Acceptable chemotherapy includes 5-6 cycles of standard platinum / taxane delivered after surgery, or 5-6 cycles intraperitoneal + intravenous (IP/IVP) chemotherapy, or 5-6 cycles of standard platinum / taxane divided into neoadjuvant and adjuvant therapy flanking primary debulking surgery. Clinical complete response is defined as normal CT scan or MRI of the abdomen/pelvis, normal chest X-ray, normal physical examination, CA-125 antigen level = 35 units/ml (assessed = 2 weeks following removal of catheter in patients receiving intraperitoneal/intravenous chemotherapy) and no symptoms suggestive of the presence of active disease. These patients will have had FANG and placebo prepared and stored from ovarian tumor cells obtained at the time of primary surgical debulking or initial diagnostic/evaluative laparoscopy (required prior to initiation of neoadjuvant chemotherapy). Patients meeting eligibility criteria (including availability of a minimum of 4 FANG aliquots) will be randomized 1:1 to receive either monthly intradermal FANG or placebo for =4 to a maximum of 12 administrations. Key trial endpoints include recurrence free survival and overall survival.
 
Detailed Description
 
Gender Age Limit
Female
 
Inclusion Criteria
  • Histologically confirmed Stage III/IV high-grade serous / endometrioid ovarian, fallopian tube or primary peritoneal cancer without prior therapy
  • Completion of primary surgical debulking and at least 5 but no more than 6 cycles of platinum / taxane adjuvant chemotherapy or chemotherapy as per Category 1 recommendations of the NCCN guidelines, including 5-6 cycles adjuvant intraperitoneal + intravenous (IP/IV) chemotherapy, or 5-6 cycles of intravenous chemotherapy divided and administered as neoadjuvant and adjuvant therapy flanking primary debulking surgery
  • Clinically defined complete response (cCR) following completion of primary surgical debulking and eligible chemotherapy. cCR is defined as normal CT scan or MRI of the abdomen/pelvis, normal chest X-ray, normal physical examination, CA-125 antigen level = 35 U/ml (assessed = 2 weeks following removal of catheter in patients receiving intraperitoneal/intravenous chemotherapy) (Richard, Sukumvanich et al. 2010) and no symptoms suggestive of the presence of active disease
  • Successful manufacturing of at least 4 (doses) vials of FANG™ and placebo
  • Recovered from all clinically relevant toxicities related to prior therapies (including neuropathy to =Grade 2)
  • ECOG performance status (PS) 0-1
  • Normal organ and marrow function as defined below: Absolute granulocyte count = 1,500/mm3 Absolute lymphocyte count = 200/mm3 Platelets = 75,000/mm3 Total bilirubin = 2 mg/dL AST(SGOT)/ALT(SGPT) = 2x institutional upper limit of normal Creatinine < 1.5 mg/dL
  • Ability to understand and the willingness to sign a written informed protocol specific consent document.
 
Exclusion Criteria
  • Surgery involving general anesthesia, radiotherapy, or immunotherapy within 4 weeks prior to randomization. Steroid therapy within 1 week prior to randomization (See Exclusion Criterion 6 below)*
  • Patients must not have received any other investigational agents within 4 weeks prior to tissue procurement
  • Chemotherapy prior to tissue acquisition for FANG™ manufacture
  • Histologically confirmed papillary serous adenocarcinoma of the uterus or disease involving myometrium/endometrium
  • Patients with history of brain metastases
  • Patients requiring steroid regimens and/or immunosuppressives other than short term (<30 days) concurrent systemic steroids =0.25 mg/kg prednisone per day (maximum 7.5 mg/day) and bronchodilators (inhaled steroids).
  • patients requiring other steroid regimens and/or immunosuppressives at randomization are excluded
  • Prior splenectomy (unless accessory spleen identified and/or without Howell-Jolly bodies on blood smear)
  • Prior malignancy (excluding surgically cured nonmelanoma carcinomas of the skin and carcinoma in situ cervix) unless in remission for = 2 years
  • Prior history of hypersensitivity reaction (HSR) to taxanes
  • Congestive heart failure (NYHA Class II, III, or IV), unstable angina, ventricular or hemodynamically significant atrial arrhythmia, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months).

 
Keywords and/or Specific Medical Conditions
  • Obstetrics and Gynecology
  • Oncology (Adult)
 
KP Clinical Facility
  • Irvine
 
Clinical Area
  • Obstetrics and Gynecology
  • Oncology (Adult)


Principal Investigator:
Devansu Tewari
Contact Information:
- Kaiser Permanente Clinical Trials
-844-294-4114
-clinical.trials@kp.org
-Southern California


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