Sarcoma
Pilot Study of Allogeneic/Syngeneic Blood Stem Cell Transplantation in Patients With High-Risk and Recurrent Pediatric Sarcomas
NCI-02-C-0259
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Investigator(s): |
Kristin Baird, M.D. Protocol Chair Phone: 301-496-4256 kbaird@mail.nih.gov
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Pediatric Oncology Phone: 1-877-624-4878 (Toll free)
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Primary Eligibility:
- Recipients
- Aged 5–35 at the time of enrollment
- Confirmed diagnosis of Ewing’s sarcoma family of tumors, desmoplastic small round cell tumor, or alveolar rhabdomyosarcoma
- Presented with bone or bone marrow metastases or metastatic disease (DSRCT), relapsed within 1 year following completion of standard front-line therapy, have persisting, unresponsive or progressive disease while receiving standard front-line chemotherapy, or have multiply recurrent disease
- Availability of a 5 or 6 antigen HLA-matched first-degree relative donor or an identical twin
- Adequate cardiac, pulmonary, renal, liver, and marrow function
- No uncontrolled fungal infection
- Not HIV positive, hepatitis B surface antigen (HBsAg) positive, or hepatitis C antibody positive
- Not lactating or pregnant
- Donors
- Weigh ≥ 15 kilograms
- First-degree relative who is 5 or 6 HLA match or identical twin
- Adequate venous access for collection of stem cells and meets the donor selection criteria NIH/CC Department of Transfusion Medicine standards
- Not HIV positive, HBsAg positive, or hepatitis C antibody positive
Study Outline:
- Donors
- Will be prepared for blood stem cell harvest with filgrastim injections 5–7 days until stem cells are collected
- Recipients
- Prior to stem cell transplant, patients will receive 1–3 cycles of chemotherapy
- Then the patient will receive chemotherapy prior to transplant
- On Day 0, stem cells will be infused intravenously
- After transplant, the patient will receive medications to prevent graft-versus-host disease
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 6/8/09
Updated: 7/27/09