Donor Stem Cell Transplant After Chemotherapy for the Treatment of Recurrent or Refractory High-Risk Solid Tumors in Pediatric and Adolescent-Young Adults

Summary

This phase II trial investigates side effects and how well donor stem cell transplant after chemotherapy works in treating pediatric and adolescent-young adults with high-risk solid tumor that has come back (recurrent) or does not respond to treatment (refractory). Chemotherapy drugs, such as fludarabine, thiotepa, etoposide, melphalan, and rabbit anti-thymocyte globulin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a donor stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When the healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets and may help destroy any remaining cancer cells.

Conditions

• Desmoplastic Small Round Cell Tumor
• Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
• Recurrent Desmoplastic Small Round Cell Tumor
• Recurrent Malignant Peripheral Nerve Sheath Tumor
• Recurrent Malignant Solid Neoplasm
• Recurrent Neuroblastoma
• Recurrent Rhabdomyosarcoma
• Refractory Desmoplastic Small Round Cell Tumor
• Refractory Malignant Peripheral Nerve Sheath Tumor
• Refractory Malignant Solid Neoplasm
• Refractory Neuroblastoma
• Refractory Rhabdomyosarcoma

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo HSCT

DRUG

Cyclosporine

Given IV and PO

DRUG

Etoposide

Given IV

DRUG

Fludarabine Phosphate

Given IV

BIOLOGICAL

Lapine T-Lymphocyte Immune Globulin

Given IV

DRUG

Melphalan

Given IV

DRUG

Mycophenolate Mofetil

Given IV or PO

DRUG

Tacrolimus

Given IV and PO

DRUG

Thiotepa

Given IV

Sponsors & Collaborators

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Jeremy S Connors, MD · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-19

Primary Completion

2024-08-26

Completion

2024-08-26

FDA Drug

Yes

Countries

• United States

Study Locations