Trial record 2 of 6 for:    Open Studies | "Hepatoblastoma"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Ann & Robert H Lurie Children's Hospital of Chicago.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT00179816
First received: September 10, 2005
Last updated: October 7, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Ewing's Sarcoma
Soft Tissue Sarcoma
Hepatoblastoma
Hodgkin's Disease
Germ Cell Tumor
Drug: High-Dose Chemotherapy with Tandem PBSC Rescue.
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High-Dose Chemotherapy With Tandem Peripheral Blood Stem Cell (PBSC) Rescue for the Treatment of High-Risk Pediatric Solid Tumors.

Resource links provided by NLM:


Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate length of remission and long term disease free survival in chemotherapy responsive high-risk pediatric solid tumor patients treated using this approach. [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
  • Evaluate correlation between cell dose and time to engraftment in high-risk pediatric solid tumor patients treated using this approach. [ Time Frame: Time to engraftment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: April 1999
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 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 Name: Cyclophosphamide call also be referred to as Cytoxan
Detailed Description:

Significant advances have been made in recent years in the treatment of solid tumors of childhood. However, much of the improvement in survival has been made in low stage and localized disease. Of significance is the fact that the improvements have come in up-front remission rates without translation into significantly high event-free survival(EFS) or overall survival (OS). This is despite the fact that these tumors as a whole are largely chemotherapy responsive.

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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179816

Contacts
Contact: Morris Kletzel, M.D. 773.880.4000 ext 4564 mkletzel@northwestern.edu
Contact: Meredith Marshall 773-880-3459 MeMarshall@childrensmemorial.org

Locations
United States, Illinois
Children's Memorial Hospital Recruiting
Chicago, Illinois, United States, 60614
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Principal Investigator: Morris Kletzel, M.D. Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

No publications provided

Responsible Party: Morris Kletzel, Children's Memorial Hospital
ClinicalTrials.gov Identifier: NCT00179816     History of Changes
Other Study ID Numbers: BMT 0499 Solid
Study First Received: September 10, 2005
Last Updated: October 7, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
wilm's tumor
stem cell transplantation
solid tumor

Additional relevant MeSH terms:
Hepatoblastoma
Hodgkin Disease
Neoplasms, Germ Cell and Embryonal
Sarcoma, Ewing's
Sarcoma
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Complex and Mixed
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on July 20, 2014