Salvage Ovarian FANG™ Vaccine + Carboplatinum

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gradalis, Inc.
ClinicalTrials.gov Identifier:
NCT01867086
First received: May 29, 2013
Last updated: November 10, 2015
Last verified: November 2015
  Purpose
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.

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


Enrollment: 1
Study Start Date: June 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vigil™ Vaccine
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.
Biological: Vigil™ Vaccine
Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks.
Other Names:
  • bi-shRNA furin and GMCSF Augmented Autologous Tumor Cell Vaccine
  • formerly known as FANG™
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 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.
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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.
  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
Dallas, Texas, United States, 75230
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: November 10, 2015
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
Vaccines
Docetaxel
Paclitaxel
Modafinil
Armodafinil
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers

ClinicalTrials.gov processed this record on July 21, 2016