Recruiting
Phase 1
Phase 2

PBSC Rescue

Sponsor:

Ann & Robert H Lurie Children's Hospital of Chicago

Code:

NCT00179816

Conditions

Ewing's Sarcoma

Soft Tissue Sarcoma

Hepatoblastoma

Hodgkin's Disease

Germ Cell Tumor

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

High-Dose Chemotherapy with Tandem PBSC Rescue.

Study Details

Brief 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.

Conditions

Ewing's Sarcoma

Soft Tissue Sarcoma

Hepatoblastoma

Hodgkin's Disease

Germ Cell Tumor

Study ID

NCT00179816

Start date

Apr, 1999

Status verified date

Oct, 2010

Completion date

Sep, 2012

Anticipated

Primary completion date

Sep, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Determine the feasibility and toxicity of tandem PBSC rescue following high dose chemotherapy as consolidation in pediatric patients with high risk solid tumors. [ Time Frame: annually ]

Central Contacts and Locations

Central contacts

Morris Kletzel, M.D.

773.880.4000mkletzel@northwestern.edu

Meredith Marshall

773-880-3459MeMarshall@childrensmemorial.org

Locations

Children's Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60614

More Information

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Last update posted

Oct 11, 2010

Last verified

Oct, 2010

Keywords

  • wilm's tumor
  • stem cell transplantation
  • solid tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ann & Robert H Lurie Children's Hospital of Chicago on 2010-10-11.