Tandem Peripheral Blood Stem Cell (PBSC) Rescue for High Risk Solid Tumors

• Status: Unknown status
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Treatments: Cyclophosphamide

Criteria

Inclusion Criteria:

• Malignant Diseases:

• 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.