Tandem Peripheral Blood Stem Cell (PBSC) Rescue for High Risk Solid Tumors
NCT ID: NCT00179816
Last Updated: 2010-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
12 participants
INTERVENTIONAL
1999-04-30
2012-09-30
Brief Summary
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Detailed Description
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Recent advances in the understanding of the biology of hematopoeitic stem cells have driven the design of treatment regimens that allow for dose intensification without unacceptable hematologic toxicity. Protocol development has focused on active agents that have a broad range between hematologic and non-hematologic toxicities. This study uses a double autologous peripheral blood stem cell rescue (PBSC) following dose-intensive chemotherapy for the treatment of high-risk pediatric solid tumors. This study utilizes PBSC to limit the risk of tumor cell contamination while retaining prompt hematologic recovery from these highly intensified treatments.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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High-Dose Chemotherapy with Tandem PBSC Rescue.
Patients on this study will undergo a tandem Peripheral Blood Stem Cell Rescue following high-dose chemotherapy. The first Peripheral Blood Stem Cell Rescue will consist of Etoposide, Carboplatin, Cyclophosphamide, and Mesna. Once the patient recovers, the patient will be evaluated again and will then undergo a second stem cell transplant consisting of the chemotherapy drugs; Melphalan, Cyclophosphamide, and Mesna.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ewing's sarcoma/PNET:
* CR1 - Metastatic disease at diagnosis, tumor volume \> 100 ml, pelvic bone primary
* CR2 - Locally recurrent disease
* Soft tissue sarcoma
* CR1 - Metastatic disease at diagnosis or locally advanced disease where local control is suboptimal (i.e., inability to provide radiation therapy due to extent of disease).
* CR2 - Locally recurrent disease (VGPR2 acceptable)
* Hepatoblastoma:
* VGPR1 - Patients with metastatic disease at diagnosis who have a persistently elevated alpha FP, or unresectable primary as a way of converting to resectable.
* CR2/VGPR2
* Hodgkin's Disease:
* VGPR1 - Progression on primary therapy/Refractory disease
* CR2/VGPR2
* Germ Cell Tumor:
* CR2/VGPR2 - recurrent disease
* Wilms Tumor:
* CR2/VGPR2 - recurrent disease
* IRB approved signed written informed consent by patient and/or their legally authorized guardian.
* Patients 21 years of age or younger at initial diagnosis, with older patients considered individually for primary pediatric disease diagnosis.
* Adequate central venous access (double lumen CVL or 2 single lumen PCVC).
* Adequate PBSC harvests with a minimum of 2.0 x 108 MNC/kg available for each PBSC rescue.
* Organ Function:
* Platelets \> 50,000/ml
* SGOT \< 10 x upper limits of normal
* Creatinine \< 1.5 x normal baseline
* Normal cardiac function in accordance with institutional policies
* Normal pulmonary function in accordance with institutional policies.
* Physiologic status:
* No active infections
* Adequate performance status as measured by Karnofsky (\> 70%) or Lansky scale (\> 60%) as appropriate for age.
* Bone Marrow Status
* No evidence of morphologic involvement with tumor at the time of transplant
Off Study Criteria:
* Severe toxicity. Contact the Study Coordinator immediately and complete Adverse Reaction Form.
* Disease progression or relapse prior to PBSC #1 or between PBSC rescue # 1 and #2.
* Inability to collect adequate numbers of PBSC for successful transplantation.
* Patient or parent/guardian refusal to remain on study.
21 Years
ALL
No
Sponsors
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Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
Responsible Party
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Children's Memorial Hospital
Principal Investigators
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Morris Kletzel, M.D.
Role: PRINCIPAL_INVESTIGATOR
Ann & Robert H Lurie Children's Hospital of Chicago
Locations
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Children's Memorial Hospital
Chicago, Illinois, United States
Countries
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Central Contacts
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Other Identifiers
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BMT 0499 Solid
Identifier Type: -
Identifier Source: org_study_id