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PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors (PEEL-224 Trial)

Phase 1 & 2

Waitlist Available

Led By Jacquelyn Crane, MD

Research Sponsored by Theodore Laetsch

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Phase 1: Age greater than or equal to 1 year and less than or equal to18 years

* Phase 2 Neuroblastoma (NBL) cohort: Age greater than or equal to 1 year and less than or equal to 30 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

The phase 1 primary objective is to determine the pediatric recommended phase 2 dose (RP2D) of PEEL-224 as a single agent (phase 1A) and in combination with vincristine and temozolomide (phase 1B). The phase 2 primary objective is to estimate the objective response rate (ORR) in children with refractory, progressive and relapsed NBL and rhabdomyosarcoma (RMS) treated with the RP2D of PEEL-224 in combination with vincristine and temozolomide.

Eligible Conditions

Solid Tumors
Neuroblastoma
Rhabdomyosarcoma
Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1A and Phase 1B: Number of participants who experience a dose limiting toxicity (DLT)

Phase 2 Neuroblastoma Cohort (NBL): Number of paricptants who achieve a complete response (CR), partial response (PR), or minor response (MR)

Phase 2 Rhabdomyosarcoma (RMS) Cohort: Number of participants who achieve a complete response (CR) or partial response (PR)

Secondary study objectives

Area under the plasma-concentration-time-curve of PEEL-224

Number of participants demonstrating anti-tumor activity of PEEL-224

Number of participants demonstrating anti-tumor activity of the combination of PEEL-224, vincristine and temozolomide

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: PEEL-224, Vincristine, and TemozolomideExperimental Treatment3 Interventions

Phase 1B will test the safety, tolerability and pharmacokinetic profile of PEEL-224 in combination with vincristine and temozolomide in pediatric subjects with refractory, progressive and relapsed solid tumors. Phase 2 will preliminary evaluate the activity profile of PEEL-224 in combination with vincristine and temozolomide in pediatric patients with refractory, progressive and relapsed NBL and RMS.

Group II: PEEL-224Experimental Treatment1 Intervention

Phase 1A will test the safety, tolerability and PK profile of PEEL-224 as a single agent in pediatric patients with refractory, progressive and relapsed solid tumors.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide (TMZ)

2005

Completed Phase 3

~760

Vincristine

2003

Completed Phase 4

~2970