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Phase I Study of ET-743 in Pediatric Refractory Solid Tumors


Phase 1
1 Year
17 Years
Not Enrolling
Both
Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

Phase I Study of ET-743 in Pediatric Refractory Solid Tumors


OBJECTIVES: I. Determine the maximum tolerated dose and dose-limiting toxicity of
ecteinascidin 743 in pediatric patients with refractory solid tumors. II. Determine the
pharmacokinetics of this drug in these patients. III. Determine the antitumor activity of
this drug in this patient population.

OUTLINE: This is a dose escalation, multicenter study. Patients are stratified according to
pretreatment (pretreated vs less heavily pretreated). Patients receive ecteinascidin 743 IV
over 3 hours on day 1. Treatment continues every 3 weeks in the absence of disease
progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of
ecteinascidin 743 until the maximum tolerated dose (MTD) is determined. The MTD is defined
as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting
toxicities.

PROJECTED ACCRUAL: A total of 3-20 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed malignant solid tumor at original
diagnosis Refractory to standard treatment or no curative therapy available No CNS tumor
No bone marrow metastases (for less heavily pretreated stratum only)

PATIENT CHARACTERISTICS: Age: At least 365 days to 17 years Performance status: Karnofsky
50-100% (for patients older than 10 years) Lansky 50-100% (for patients 10 years and
younger) Life expectancy: At least 8 weeks Hematopoietic: Absolute neutrophil count at
least 1,500/mm3 Platelet count at least 100,000/mm3 (transfusion independent) Hemoglobin
at least 8.0 g/dL (RBC transfusion allowed) Hepatic: Bilirubin no greater than normal SGPT
no greater than 2.5 times normal Albumin at least 2 g/dL Alkaline phosphatase normal Gamma
glutamyl transferase less than 2.5 times normal Renal: Creatinine no greater than 1.5
times normal OR Creatinine clearance or GFR at least lower limit of normal Other: Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception Creatine phosphokinase less than 2 times normal No uncontrolled infection
Seizure disorder allowed if well controlled on anticonvulsants No CNS toxicity greater
than grade II

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 week since prior biologic therapy
and recovered At least 1 week since prior growth factor therapy At least 6 months since
prior peripheral blood stem cell transplantation and no evidence of graft-vs-host disease
For less heavily pretreated stratum: No prior peripheral blood stem cell transplantation
Chemotherapy: At least 4 weeks since prior myelosuppressive chemotherapy (6 weeks for
nitrosoureas) and recovered No prior ecteinascidin 743 For less heavily pretreated
stratum: No more than 2 prior chemotherapy regimens Endocrine therapy: Not specified
Radiotherapy: At least 2 weeks since prior local palliative radiotherapy (small port) At
least 6 weeks since prior substantial bone marrow radiotherapy At least 6 months since
prior craniospinal radiotherapy or radiotherapy to 50% or greater of pelvis For less
heavily pretreated stratum: No prior craniospinal irradiation of 18Gy or greater No prior
irradiation to greater than 50% of pelvis Recovered from toxic effects of prior
radiotherapy Surgery: Not specified Other: No concurrent foods or medication that
interferes with P-450 metabolism Anticonvulsants allowed

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Sylvain Baruchel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Hospital for Sick Children

Authority:

United States: Federal Government

Study ID:

CDR0000068273

NCT ID:

NCT00006463

Start Date:

October 2000

Completion Date:

Related Keywords:

  • Unspecified Childhood Solid Tumor, Protocol Specific
  • unspecified childhood solid tumor, protocol specific
  • Neoplasms

Name

Location

Baylor College of MedicineHouston, Texas  77030
Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Shands Hospital and Clinics, University of FloridaGainesville, Florida  32610-100277
Children's Hospital of MichiganDetroit, Michigan  48201
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Boston Floating Hospital Infants and ChildrenBoston, Massachusetts  02111
Beckman Research Institute, City of HopeLos Angeles, California  91010
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Hackensack University Medical CenterHackensack, New Jersey  07601
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital of Orange CountyOrange, California  92668
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
Children's Hospital Medical Center - CincinnatiCincinnati, Ohio  45229-3039
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Lucile Packard Children's Hospital at StanfordPalo Alto, California  94304
Mott Children's HospitalAnn Arbor, Michigan  48109-0914
Columbia Presbyterian HospitalNew York, New York  10032
Saint Jude Children's Research HospitalMemphis, Tennessee  38105-2794
University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001
Children's Memorial Hospital, ChicagoChicago, Illinois  60614