A Two-part Phase IIb Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Ewing's Sarcoma

Conditions

• Ewing's Sarcoma

Eligibility Criteria

Sex

ALL

Age

2 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Vigil — BIOLOGICAL
  Vigil 1.0 x 10e7 cells/injection, minimum of 4 to a maximum of 12 administrations.
• Temozolomide — DRUG
  oral temozolimidetemozolomide 100 mg/m2 daily (Days 1 - 5, total dose 500 mg/m2/cycle)
• Irinotecan — DRUG
  irinotecan 50 mg/m2 daily (Days 1 - 5, total dose 250mg/m2/cycle), orally or irinotecan 20mg/m2 daily (Days 1 - 5, total dose 100mg/m2/cycle ), intravenously
• Gemcitabine — DRUG
  675 mg/m2 IV at a rate of 10 mg/m2/min on Day 1 and Day 8 every 21 days
• Docetaxel — DRUG
  75 mg/m2 IV administered on Day 8 and every 21 days

Study Details

A two-part trial in patients with metastic Ewing's sarcoma. Participants in Part 1 will be randomized to receive either Vigil immunotherapy or gemcitabine and docetaxel with the objective of comparing the overall survival between the two arms. Participants enrolled in Part 2 will receive Vigil immunotherapy in combination of temozolomide and irinotecan with the objective to determine the safety profile of the combination treatment.

Key Dates

Start date

Feb 10, 2016

Status verified

Dec 2022

Primary completion

Nov 12, 2018

Completion

Dec 23, 2020

Study Design

Enrollment

22 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: Vigil Alone
  Vigil immunotherapy 1.0 x 107 cells/injection; minimum of 4 to a maximum of 12 administrations every 28 days
• Active Comparator: Part 1: Gemicitabine and Docetaxel
  Gemcitabine 675 mg/m2 IV at 10 mg/m2/min D1 and Docetaxel 75 mg/m2 IV starting on D8 and given every 21 days.
• Experimental: Part 2: Vigil plus Temozolomide and Irinotecan
  (i) oral temozolomide 100 mg/m2 daily (Days 1 - 5, total dose 500 mg/m2/cycle), (ii) irinotecan 50 mg/m2 daily (Days 1 - 5, total dose 250mg/m2/cycle), orally or irinotecan 20mg/m2 daily (Days 1 - 5, total dose 100mg/m2/cycle ), intravenously (iii) peg-filgrastim 100μg/kg (Day 6) subcutaneously (optional and may be administered at home), and (iv) Vigil 1.0 x 107 cells/injection, intradermally on Day 15 and every 3 weeks thereafter. One cycle = 21 days.

Primary Outcome Measure

Number of Participants With Adverse Events Determined by Laboratory Assessments and Physical Examinations [ Time Frame: 30 days of last treatment dosing ]

Locations (6)

Find similar trials in Little Rock, AR

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