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

April 3, 2019 updated by: Doug Hawkins, Seattle Children's Hospital

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98105
        • Children's Hospital and Regional Medical Center - Seattle
      • Seattle, Washington, United States, 98109-1024
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age:

  • 1 to 30

Performance status:

  • 0-2

Life expectancy:

  • At least 2 months

Hematopoietic:

  • 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)

Hepatic:

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

Renal:

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

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

Cardiovascular:

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

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

Neurologic:

  • Adequate CNS function as defined by:

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

Other:

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

PRIOR CONCURRENT THERAPY:

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

Chemotherapy:

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

Endocrine therapy:

  • Not specified

Radiotherapy:

  • 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

Surgery:

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seattle Children's Hospital

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Douglas Hawkins, MD, Seattle Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1997

Primary Completion (Actual)

December 19, 2002

Study Completion (Actual)

December 19, 2002

Study Registration Dates

First Submitted

April 6, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

April 5, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHMC-6006
  • CDR0000066029 (Registry Identifier: PDQ (Physician Data Query))
  • FHCRC-1244.00
  • NCI-G98-1373

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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