VITAS: Atezolizumab in Combination With Chemotherapy for Pediatric Relapsed/Refractory Solid Tumors

Conditions

• Rhabdomyosarcoma
• Solid Tumor

Eligibility Criteria

Sex

ALL

Age

6 Months - 30 Years

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  Feasibility and RMS Cohorts: Administered at 15 mg/kg (max 1,200 mg) IV on Day 1 of each 21-day cycle
• Vincristine — DRUG
  Feasibility and RMS Cohorts: Administered at 1.5 mg/m\^2 (max 2 mg) IV on Day 1 of each 21-day cycle
• Irinotecan — DRUG
  Feasibility and RMS Cohorts: Administered at 50 mg/m2 IV on Days 1-5 of each 21-day cycle
• Temozolomide — DRUG
  Feasibility and RMS Cohorts: Administered at 100 mg/m\^2 (max 200 mg) IV or PO 1 hour before irinotecan injection on Days 1-5 if each 21-day cycle

Study Details

This trial is a multi-center, non-randomized, open-label Phase I/II study evaluating the feasibility and efficacy of vincristine, irinotecan, temozolomide, and atezolizumab in children with relapsed/refractory solid tumors.

Key Dates

Start date

Apr 18, 2023

Status verified

May 2026

Primary completion

Jan 31, 2027

Completion

Jan 31, 2027

Study Design

Enrollment

23 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Feasibility Cohort: Patients with relapsed or refractory solid tumors
  Six (6) participants with relapsed or refractory solid tumor will be enrolled. Atezolizumab will be administered in combination with vincristine, irinotecan, and temozolomide for up to 2 years or until the participant experiences disease progression or an unacceptable toxicity.
• Experimental: Rhabdomyosarcoma (RMS) Cohort: Patients with rhabdomyosarcoma
  Seventeen (17) participants with RMS, including the six participants from the Feasibility Cohort, will be enrolled. At least 8 of the RMS participants must have a tumor that expresses the protein PD-L1. Atezolizumab will be administered in combination with vincristine, irinotecan, and temozolomide for up to 2 years or until the participant experiences disease progression or an unacceptable toxicity.

Primary Outcome Measure

Number of participants with Dose-limiting Toxicities (DLTs) [ Time Frame: Beginning of cycle 3, or 30 days after the second cycle has started, whichever is earlier (each cycle is 21 days) ]

Central Contacts

• Arhanti Sadanand, MD
  214-645-9122
  [email protected]
• Sara Runyan
  214-648-7146
  [email protected]

Locations (7)

Find similar trials in Chicago, IL

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