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New treatment option for Refractory and/or Relapsed Metastatic Solid Tumors
Official title Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
ClinicalTrials.gov ID: NCT01804634
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for refractory and/or relapsed metastatic solid tumors.
Also referred to as cytoxan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 50
You may be able to join if
- 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...
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- The Bronx, New York, United States
- Valhalla, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; The Bronx, New York, United States; Valhalla, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.