RecruitingPhase 2NCT01804634

Reduced Intensity Haploidentical BMT for High Risk Solid Tumors

A Phase II Trial of Reduced Intensity Conditioning and Partially HLA-mismatched (HLA-haploidentical) Related Donor Bone Marrow Transplantation for High-risk Solid Tumors


Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

60 participants

Start Date

Mar 27, 2013

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to see if giving reduced intensity chemotherapy, haploidentical bone marrow, post-transplant cyclophosphamide and shortened duration tacrolimus is safe and feasible for patients with very high-risk solid tumors.


Eligibility

Min Age: 1 YearMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a bone marrow transplant from a half-matched family member (called a haploidentical transplant) can help children and young adults with high-risk solid tumors — cancers with a very poor prognosis — that have not responded to standard treatment. **You may be eligible if...** - You are between 1 and 50 years old with a confirmed high-risk solid tumor (such as high-risk neuroblastoma, stage 4 rhabdomyosarcoma, metastatic Ewing sarcoma, or other advanced solid tumors with less than 10% expected survival) - You have received standard upfront treatment and your disease is stable - You have a half-matched family member willing to donate bone marrow - Your heart, liver, kidney, and lung function are within acceptable limits **You may NOT be eligible if...** - You are HIV positive - You are pregnant or not using adequate contraception - You have an uncontrolled active infection (viral, bacterial, or fungal) - There are certain immune incompatibilities with your donor (positive crossmatch) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclophosphamide

preparative regimen

DRUGFludarabine
RADIATIONlow dose total body irradiation
DRUGMelphalan
DRUGTacrolimus

Locations(3)

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Albert Einstein College of Medicine, Children's Hospital at Montefiore

The Bronx, New York, United States

New York Medical Center/ Maria Fareri Children's Hospital

Valhalla, New York, United States

View Full Details on ClinicalTrials.gov

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NCT01804634