Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
Part of paid clinical trials in Baltimore, Maryland.
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Study ID
- NCT01804634
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Refractory and/or Relapsed Metastatic Solid Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 1 Year - 50 Years
- Healthy Volunteers
- Not accepted
Interventions
- Cyclophosphamide — DRUGpreparative regimen
- Fludarabine — DRUG
- low dose total body irradiation — RADIATION
- Melphalan — DRUG
- Tacrolimus — DRUG
Study Details
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.
Key Dates
- Start date
- Mar 27, 2013
- Status verified
- Mar 2026
- Primary completion
- Jan 31, 2027
- Completion
- Jan 31, 2030
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Reduced intensity conditioningFludarabine IV infusion over 30 minutes on D-7 to D-3. The dose will be 30 mg/m2/dose (adjusted for renal function). Melphalan: IV infusion over 30-60 minutes, depending on volume, on D-2. The dose will be 100mg/m2.Total body irradiation: 200 cGy AP/PA with 4MV or 6MV photons at 8 12 cGy/min at the point of prescription (average separation of measurements at mediastinum, abdomen, and hips) will be administered in a single fraction on day -1. Bone Marrow will be harvested and infused on day 0. Post-transplantation Cyclophosphamide 50mg/kg will be given on D+3 post-transplant (within 60-72 hr of marrow infusion) and on D+4 post-transplant. Tacrolimus begins on Day 5, at least 24 hours after completion of posttransplantation Cy at 0.015mg/kg IBW/dose IV over 3 hours every 12 hours. Mycophenolic acid mofetil (MMF) F will be given at a dose of 15 mg/kg PO TID (based upon actual body weight) with the maximum total daily dose not to exceed 3 grams (1 g PO TID).
Primary Outcome Measure
Safety of Shortened duration of tacrolimus as assessed by number of participants with NRM and Grade III-IV acute GVHD at Day 120 [ Time Frame: up to 120 Days ]
Central Contacts
- Heather Symons, MD, MHS410-502-4997
- Jasmine Brooks, BA667-306-8335
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231 | Heather Symons, MD, MHS (PRINCIPAL_INVESTIGATOR) |
| Albert Einstein College of Medicine, Children's Hospital at Montefiore | The Bronx | New York | 10467 | David Loeb, MD (PRINCIPAL_INVESTIGATOR) |
| New York Medical Center/ Maria Fareri Children's Hospital | Valhalla | New York | 10595 | Aliza Gardenswartz, MD (PRINCIPAL_INVESTIGATOR) Mitchell Cario, MD (SUB_INVESTIGATOR) |