Suspended

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.

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What is being tested

filgrastim

+ carboplatin

+ cyclophosphamide

BiologicalDrugProcedure
Who is being recruted

From 1 to 30 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 1997
See protocol details

Summary

Principal SponsorSeattle Children's Hospital
Last updated: April 5, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 1997

Actual date on which the first participant was enrolled.

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.

NCT00003194
Principal SponsorSeattle Children's Hospital
Last updated: April 5, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

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

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 to 30 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

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 Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Children's Hospital and Regional Medical Center - Seattle

Seattle, United StatesOpen Children's Hospital and Regional Medical Center - Seattle in Google Maps

Fred Hutchinson Cancer Research Center

Seattle, United States
Suspended2 Study Centers