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Status:

RECRUITING

Reduced Intensity Haploidentical BMT for High Risk Solid Tumors

Lead Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Refractory and/or Relapsed Metastatic Solid Tumors

Eligibility:

All Genders

1-50 years

Phase:

PHASE2

Brief 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 pa...

Detailed Description

Allogeneic hematopoietic stem cell transplantation (HSCT) may be associated with a clinically significant "graft-versus-tumor" (GVT) effect, even against disease that is unresponsive to chemotherapy a...

Eligibility Criteria

Inclusion

  • Presence of a suitable related HLA-haploidentical bone marrow donor.a. The donor and recipient must be identical at at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. A minimum match of 5/10 is therefore required, and will be considered sufficient evidence that the donor and recipient share one HLA haplotype.
  • 1 year-50 years
  • Patients must have a confirmed histopathologic diagnosis and be classified as high risk defined by having an expected survival of \< 10%. Examples include:
  • Neuroblastoma or ganglioneuroblastoma
  • Failure to achieve at least a PR after induction therapy with COG ANBL0532 or standard chemotherapy
  • Refractory to induction chemotherapy with COG ANBL0532 or standard chemotherapy
  • Patients with high risk disease as defined in Appendix 1 whose autologous peripheral blood stem cell product is contaminated with neuroblastoma or who do not have an autologous product available
  • Patients with high risk disease as defined in Appendix 1 who do not meet eligibility requirements/organ function requirements for myeloablative conditioning. Patients with \>5 identified lesions on the end of induction (COG ANBL0532 or standard chemotherapy) MIBG scan
  • Stage 4 rhabdomyosarcoma
  • Metastatic Ewing Sarcoma
  • Osteosarcoma with metastatic disease beyond the lungs and/or with lung metastases not amenable to resection
  • Desmoplastic small round cell tumor
  • Any other solid tumor and soft tissue sarcoma with an estimated \<10% chance of survival will be considered on a case by case basis at the departmental tumor board and/or sarcoma meeting
  • Previous therapy:
  • It is expected that patients will have received upfront standard of care therapy for their respected disease
  • Patients who relapse after either single or tandem autologous BMT are eligible (\> 6 months must have elapsed from start of last BMT).
  • Patients must be recovered from the acute toxicities of any prior chemo/radio/immunotherapy or BMT
  • Patients do not need to have measurable disease at time of enrollment. Patients with measurable disease must have stable disease by RECIST criteria on two scans at least 6 weeks apart.
  • Patients with adequate organ function as measured by
  • Cardiac: Left ventricular ejection fraction at rest must be ≥ 35%, or shortening fraction \> 25%.
  • Hepatic: Bilirubin ≤ 3.0 mg/dL; and ALT, AST, and Alkaline Phosphatase \< 5 x ULN.
  • Renal: Serum creatinine within normal range for age, or if serum creatinine outside normal range for age, then renal function (creatinine clearance or GFR) \> 40 mL/min/1.73m2.
  • Pulmonary: FEV1, FVC, DLCO (diffusion capacity) \> 50% predicted (corrected for hemoglobin); if unable to perform pulmonary function tests, then O2 saturation \> 92% on room air.
  • Good performance status (Karnofsky/Lansky 60-100)
  • Patients (Parents/guardians for those \<18) and donors must be able to sign consent forms.
  • Patients must be willing to participate in all stages of treatment
  • Criteria for recipient ineligibility Patients will not be excluded on the basis of sex, racial or ethnic background.
  • HIV-positive
  • Donor (donor anti-recipient) ABO incompatibility if an ABO compatible donor is available.
  • Positive leukocytotoxic crossmatch
  • Women of childbearing potential who currently are pregnant (HCG+) or who are not practicing adequate contraception
  • Uncontrolled viral, bacterial, or fungal infections.
  • Criteria for donor eligibility Age \>0.5 years
  • Donors must meet the selection criteria as defined by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FACT).
  • Lack of recipient anti-donor HLA antibody Note: In some instances, low level, non-cytotoxic HLA specific antibodies may be permissible if they are found to be at a level well below that detectable by flow cytometry. This will be decided on a case-by-case basis by the PI and one of the immunogenetics directors.
  • In the event that two or more eligible donors are identified, the following order of priority will be used to determine the preferred donor:
  • Medically and psychologically fit and willing to donate
  • Killer Immunoglobulin Receptor (KIR) Haplotype B Donor
  • Red blood-cell compatibility (in order of preference)
  • RBC cross-match compatible
  • Minor ABO incompatibility
  • Major ABO incompatibility
  • For CMV seronegative recipients, a CMV seronegative donor. For CMV seropositive recipients, a CMV seropositive donor is preferred.
  • When possible, HLA-mismatched donors will be prioritized over HLA-matched to maximize an allogeneic benefit.
  • If more than one preferred donor is identified from the above list and there is no medical reason to prefer one of them, then the following guidelines are recommended:
  • If the patient is male, choose a male donor
  • Choose the youngest preferred donor
  • If the patient and family express a strong preference for a particular donor, use that one.

Exclusion

    Key Trial Info

    Start Date :

    March 27 2013

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    January 1 2030

    Estimated Enrollment :

    60 Patients enrolled

    Trial Details

    Trial ID

    NCT01804634

    Start Date

    March 27 2013

    End Date

    January 1 2030

    Last Update

    March 11 2025

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, United States, 33701

    2

    The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, United States, 21231

    3

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

    The Bronx, New York, United States, 10467

    4

    New York Medical Center/ Maria Fareri Children's Hospital

    Valhalla, New York, United States, 10595