Trial of Nab-paclitaxel in Patients With Desmoid Tumors and Multiply Relapsed/Refractory Desmoplastic Small Round Cell Tumors and Ewing Sarcoma

Summary

A two-cohort, fase II, open-label, non-randomized, multicenter clinical trial. 14 sites in Spain.

Cohort 1: Subjects with desmoid tumor (DT) Cohort 2: Subjects with desmoplastic small round cell tumor or Ewing sarcoma (DSRCT and ES)

Nab-paclitaxel (ABRAXANE) will be administered as follows:

Age ≥ 21 and ≤ 80 years: 125 mg/m2 days 1, 8 and 15 in cycles of 28 days Age ≥ 6 months and ≤ 20 years: 240 mg/m2 days 1, 8 and 15 in cycles of 28 days

Subjects in the DT cohort will receive a maximum of three cycles. Subjects in the DSRCT and ES cohort will receive unlimited cycles until disease progression, the subject begins a new anticancer treatment, withdrawal of parent/guardian/subject consent/assent, parent/guardian/subject refusal, physician decision, toxicity that cannot be managed by dose delay or dose reduction alone or the study ends for any reason.

The main goal is to determine the objective response rate (ORR), using RECIST 1.1 criteria and to determine the clinical benefit rate (CBR), defined as CR+PR+SD for 3 months with improvement of pain with at least minimally important difference (MID) of 2 in subjects with desmoid tumors (DT cohort) and to determine the objective response rate (ORR) in subjects with desmoplastic small round cell tumor and Ewing sarcoma, using RECIST 1.1 criteria (DSRCT and ES cohort)

Conditions

• Tumor, Desmoplastic Small Round Cell, Adult
• Tumor, Desmoplastic Small Round Cell, Childhood
• Sarcoma, Ewing
• Sarcoma
• Desmoid

Interventions

DRUG

nab paclitaxel

Subjects in the DT cohort will receive a maximum of three cycles. Subjects in the DSRCT and ES cohort will receive unlimited cycles until disease progression, the subject begins a new anticancer treatment, withdrawal of parent/guardian/subject consent/assent, parent/guardian/subject refusal, physician decision, toxicity that cannot be managed by dose delay or dose reduction alone or the study ends for any reason

Sponsors & Collaborators

• Grupo Espanol de Investigacion en Sarcomas

  lead OTHER

Principal Investigators

• Javier Martin Broto, MD · Hospitales Universitarios Virgen del Rocío

• Jaume Mora, MD · Hospital Sant Joan de Deu

• Javier Martínez Trufero, MD · Hospital Miguel Servet

• Francisco Bautista, MD · Hospital Universitario Niño Jesús

• Antonio López Pousa, MD · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

• Roberto Díaz, MD · Hospital Universitario La Fe

• José Antonio López-Martín, MD · Hospital Universitario 12 de Octubre

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

6 Months

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-09

Primary Completion

2021-09-30

Completion

2021-09-30

Countries

• Spain

Study Locations