Is NCT01804634 recruiting in Valhalla, NY?

Yes, NCT01804634 is currently enrolling participants at its Valhalla, NY location. This high risk solid tumors clinical trial is accepting qualified participants.

How do I join the high risk solid tumors clinical trial in Valhalla?

To join this clinical trial in Valhalla, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Valhalla clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

High Risk Solid Tumors Clinical Trial in Valhalla, NY: Cyclophosphamide

About This High Risk Solid Tumors Study in Valhalla

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.

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Who Can Participate

Inclusion Criteria

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Valhalla?

Yes, this clinical trial (NCT01804634) has an active research site in Valhalla, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

High Risk Solid Tumors Treatment Options in Valhalla, NY

If you're searching for high risk solid tumors treatment options in Valhalla, NY, this clinical trial (NCT01804634) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Valhalla research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced high risk solid tumors specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all high risk solid tumors clinical trials near you to find additional studies recruiting in your area.

High Risk Solid Tumors Clinical Trial in Valhalla, NY

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