Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003194
Recruitment Status : Unknown
Verified March 2003 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : February 9, 2009
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have recurrent or refractory solid tumors.

Condition or disease Intervention/treatment Phase
Unspecified Childhood Solid Tumor, Protocol Specific Biological: filgrastim Drug: carboplatin Drug: cyclophosphamide Drug: etoposide Drug: thiotepa Drug: topotecan hydrochloride Procedure: peripheral blood stem cell transplantation Phase 1

Detailed Description:


  • Determine the maximum tolerated dose of thiotepa in combination with carboplatin and topotecan with peripheral blood stem cell transplantation in patients with recurrent or refractory pediatric solid tumors.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a dose escalation study of thiotepa.

Patients may receive 2 courses of mobilization comprising cyclophosphamide and etoposide with filgrastim (G-CSF) support and peripheral blood stem cell (PBSC) collection.

Patients receive thiotepa IV over 2 hours on days 0 and 1; topotecan IV over 30 minutes on days 0-4; and carboplatin IV over 2 hours on days 2 and 3. Patients also receive G-CSF beginning on day 5, 24-36 hours following the last dose of topotecan. PBSC are reinfused on day 6 (36-48 hours following the last dose of topotecan) of each course of therapy. Patients receive 3 courses of therapy.

Cohorts of 3-6 patients receive escalating doses of thiotepa until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 1 and 2 years.

PROJECTED ACCRUAL: A maximum of 24 patients will be accrued into this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Primary Purpose: Treatment
Official Title: A Phase I Study of Thiotepa in Combination With Carboplatin and Topotecan With Peripheral Blood Progenitor Cell Support for the Treatment of Children With Recurrent or Refractory Solid Tumors.
Study Start Date : July 1997

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Ages Eligible for Study:   1 Year to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven recurrent or refractory pediatric solid tumor
  • Bone marrow metastases allowed



  • 1 to 30

Performance status:

  • 0-2

Life expectancy:

  • At least 2 months


  • Absolute neutrophil count at least 1,000/mm3
  • Platelet count at least 100,000/mm3 (transfusion independent)
  • Hemoglobin at least 10 g/dL (RBC transfusion allowed)


  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 2.5 times normal


  • Adequate renal function as defined by one of the following:

    • GFR by creatinine clearance
    • Radioisotope GFR
    • Iothalamate at least 70 mL/min


  • Adequate cardiac function as defined by one of the following:

    • Ejection fraction at least 55% by MUGA
    • Fractional shortening at least 28% by echocardiogram


  • Adequate CNS function as defined by:

    • Seizure disorder, if present, controlled by anticonvulsants
    • CNS toxicity no greater than grade 2


  • No uncontrolled infections
  • Not pregnant or nursing
  • No allergy to platinum compounds
  • No history of allergy to etoposide (unless mobilization phase not required)


Biologic therapy:

  • Recovered from prior immunotherapy
  • At least 1 week since prior cytokines
  • At least 3 months since prior bone marrow or peripheral blood stem cell transplantation
  • No concurrent immunomodulator
  • No concurrent cytokines


  • At least 3 weeks (6 for nitrosourea) since prior chemotherapy and recovered
  • No prior thiotepa
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified


  • Recovered from prior radiotherapy
  • At least 6 months since prior total body irradiation conditioning
  • No concurrent radiotherapy to greater than 10% of total liver, lung, or bone marrow


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003194

United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Seattle Children's Hospital
National Cancer Institute (NCI)
Study Chair: Douglas Hawkins, MD Seattle Children's Hospital Identifier: NCT00003194     History of Changes
Other Study ID Numbers: CDR0000066029
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: March 2003

Keywords provided by National Cancer Institute (NCI):
unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Topoisomerase I Inhibitors