Salvage Ovarian FANG Vaccine + Carboplatinum

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Gradalis, Inc.
Sponsor:
Information provided by (Responsible Party):
Gradalis, Inc.
ClinicalTrials.gov Identifier:
NCT01867086
First received: May 29, 2013
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

This is a Phase II study of FANG™ autologous tumor cell vaccine integrated with carboplatinum. All patients will have had FANG™ 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 FANG™ 1.0 x 10e7 cells/intradermal injection, once every 3 weeks.


Condition Intervention Phase
Stage III Ovarian Cancer
Stage IV Ovarian Cancer
Biological: Vaccine: FANG™ Vaccine
Drug: Carboplatinum
Drug: Carboplatinum and Taxol
Biological: FANG
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Adjuvant Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine (FANG™) Integrated With Chemotherapy for Patients With Recurrent Cisplatinum Sensitive Ovarian Cancer Participating in Study CL-PTL 105

Resource links provided by NLM:


Further study details as provided by Gradalis, Inc.:

Primary Outcome Measures:
  • Response Rate [ Time Frame: Participants will be followed up to 24 months ] [ Designated as safety issue: No ]
    To determine the response rate and time to progression (TTP) following chemotherapy integrated with FANGTM vaccine in patients with ovarian cancer who recurred following standard of care post treatment observation in study CL-PTL 105 as well as in those for whom vaccine was prepared but did not otherwise qualify.


Secondary Outcome Measures:
  • Time to Progression [ Time Frame: Patients will be followed for 24 months ] [ Designated as safety issue: No ]
    To determine the response rate and time to progression (TTP) following chemotherapy integrated with FANGTM vaccine in patients with ovarian cancer who recurred following standard of care post treatment observation in study CL-PTL 105 as well as in those for whom vaccine was prepared but did not otherwise qualify.


Estimated Enrollment: 14
Study Start Date: June 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FANG Biological: Vaccine: FANG™ Vaccine
Patients meeting eligibility criteria will receive FANG™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks.
Other Name: bi-shRNA furin and GMCSF Augmented Autologous Tumor Cell Vaccine
Drug: Carboplatinum
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 FANG™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks.
Drug: Carboplatinum and Taxol
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 FANG™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks.
Biological: FANG

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 FANG™ vaccine.
  5. Recovered from all clinically relevant toxicities related to prior therapies.
  6. ECOG PS 0-2 prior to FANG™ 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01867086

Locations
United States, Texas
Mary Crowley Cancer Research Centers Recruiting
Dallas, Texas, United States, 75230
Contact: Referral Office    972-566-3000    referral@marycrowley.org   
Principal Investigator: Minal Barve, MD         
Sponsors and Collaborators
Gradalis, Inc.
Investigators
Principal Investigator: Minal Barve, MD Principal Investigator
  More Information

Publications:
Responsible Party: Gradalis, Inc.
ClinicalTrials.gov Identifier: NCT01867086     History of Changes
Other Study ID Numbers: CL-PTL 110
Study First Received: May 29, 2013
Last Updated: February 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gradalis, Inc.:
ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014