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Salvage Ovarian FANG™ Vaccine + Carboplatinum

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ClinicalTrials.gov Identifier: NCT01867086
Recruitment Status : Completed
First Posted : June 3, 2013
Results First Posted : May 1, 2018
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gradalis, Inc.

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 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 or disease Intervention/treatment Phase
Stage III Ovarian Cancer Stage IV Ovarian Cancer Biological: Vigil™ Vaccine Drug: Carboplatinum Drug: Carboplatinum and Taxol Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 8, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Time to Progression (TTP) [ Time Frame: 24 months ]
    Time to progression (TTP) will be determined following Carboplatinum integrated with Vigil vaccine in patients failing standard of care in study CL-PTL 105 or in those not otherwise qualifying after vaccine production. This will be measured from the treatment start date (date of first dose) to either the date the patient is first recorded as having disease recurrence (even if the patient went off treatment because of toxicity), or the date of death if the patient dies due to any causes before progression.

  2. Response Rate [ Time Frame: Up to 12 months ]
    Response will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline.


Secondary Outcome Measures :
  1. Immune Analysis in Blood [ Time Frame: Baseline, End of Treatment (30 days after last dose) up to 12 months ]
    To determine if subjects will have a positive (defined as >10 ELISPOTS from baseline) immune response to Vigil. Blood was collected to compare ELISPOT results from baseline until 30 days after last dose.


Other Outcome Measures:
  1. Number of Alive Subjects [ Time Frame: 24 months ]
    Survival status of patients after treatment will be determined.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Gradalis, Inc.
ClinicalTrials.gov Identifier: NCT01867086     History of Changes
Other Study ID Numbers: CL-PTL 110
First Posted: June 3, 2013    Key Record Dates
Results First Posted: May 1, 2018
Last Update Posted: June 19, 2018
Last Verified: May 2018

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