Ecteinascidin 743 in Treating Children With Refractory Solid Tumors
Phase I Study of ET-743 in Pediatric Refractory Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Ecteinascidin 743 may be an effective treatment for solid tumors.
PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating children who have refractory solid tumors.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Victoria
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Parkville, Victoria, Australia, 3052
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Australia, 6001
- Princess Margaret Hospital for Children
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canada, H3H 1P3
- Montreal Children's Hospital
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Montreal, Quebec, Canada, H3T 1C5
- Hôpital Sainte Justine
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Arkansas
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Little Rock, Arkansas, Forente stater, 72205
- University of Arkansas for Medical Sciences
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California
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La Jolla, California, Forente stater, 92093-0658
- University of California San Diego Cancer Center
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Los Angeles, California, Forente stater, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Forente stater, 91010
- Beckman Research Institute, City of Hope
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Los Angeles, California, Forente stater, 90027-0700
- Children's Hospital Los Angeles
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Orange, California, Forente stater, 92868
- Children's Hospital of Orange County
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Palo Alto, California, Forente stater, 94304
- Lucile Packard Children's Hospital at Stanford
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San Francisco, California, Forente stater, 94115-0128
- UCSF Cancer Center and Cancer Research Institute
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District of Columbia
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Washington, District of Columbia, Forente stater, 20010-2970
- Children's National Medical Center
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Florida
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Gainesville, Florida, Forente stater, 32610-100277
- Shands Hospital and Clinics, University of Florida
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Georgia
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Atlanta, Georgia, Forente stater, 30322
- Emory University Hospital - Atlanta
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Illinois
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Chicago, Illinois, Forente stater, 60614
- Children's Memorial Hospital, Chicago
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Indiana
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Indianapolis, Indiana, Forente stater, 46202-5265
- Indiana University Cancer Center
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Maryland
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Baltimore, Maryland, Forente stater, 21231
- Johns Hopkins Oncology Center
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Forente stater, 02111
- Boston Floating Hospital Infants and Children
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109
- Mott Children's Hospital
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Detroit, Michigan, Forente stater, 48201
- Children's Hospital of Michigan
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Forente stater, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Kansas City, Missouri, Forente stater, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, Forente stater, 63104
- Cardinal Glennon Children's Hospital
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New Jersey
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Hackensack, New Jersey, Forente stater, 07601
- Hackensack University Medical Center
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New York
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Buffalo, New York, Forente stater, 14263-0001
- Roswell Park Cancer Institute
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New York, New York, Forente stater, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Forente stater, 10032
- Columbia Presbyterian Hospital
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Syracuse, New York, Forente stater, 13210
- State University of New York - Upstate Medical University
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North Carolina
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Durham, North Carolina, Forente stater, 27710
- Duke Comprehensive Cancer Center
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Ohio
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Cincinnati, Ohio, Forente stater, 45229-3039
- Children's Hospital Medical Center - Cincinnati
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Forente stater, 15213
- Children's Hospital of Pittsburgh
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South Carolina
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Charleston, South Carolina, Forente stater, 29425-0721
- Medical University of South Carolina
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Tennessee
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Memphis, Tennessee, Forente stater, 38105-2794
- Saint Jude Children's Research Hospital
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Nashville, Tennessee, Forente stater, 37232-6838
- Vanderbilt Cancer Center
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Texas
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Fort Worth, Texas, Forente stater, 76104
- Cook Children's Medical Center - Fort Worth
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Houston, Texas, Forente stater, 77030
- Baylor College of Medicine
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Houston, Texas, Forente stater, 77030-4009
- University of Texas - MD Anderson Cancer Center
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San Antonio, Texas, Forente stater, 78284-7811
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City, Utah, Forente stater, 84132
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, Forente stater, 98105
- Children's Hospital and Regional Medical Center - Seattle
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Wisconsin
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Madison, Wisconsin, Forente stater, 53792-0001
- University of Wisconsin Hospital and Clinics
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Milwaukee, Wisconsin, Forente stater, 53226
- Midwest Children's Cancer Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Therapy ECTEINASCIDIN 743 (1100 ug/m2 )
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Andre navn:
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Eksperimentell: ECTEINASCIDIN 743 (1300 ug/m2)
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Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Progresjonsfri overlevelse
Tidsramme: Lengde på studiet
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Lengde på studiet
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Dose Limiting Toxicity
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To determine the maximum tolerated dose (MTD) of vincristine, when used in combination with irinotecan, and the dose-limiting toxicity (DLT) of this combination; irinotecan will be administered IV over 1 hour x 5 days, q 21 days, with vincristine IVP days 1, 8, 15, 22, 29, every 42 days, to children with refractory solid tumors.
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Determine a safe and tolerable dose of vincristine, when administered with irinotecan
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To determine a safe and tolerable dose of vincristine, when administered with irinotecan, for future evaluation in phase II clinical trials.
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Determine the pharmacokinetics of vincristine and irinotecan
Tidsramme: Length of study
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To determine the pharmacokinetics of vincristine and irinotecan (and its active metabolite SN-38) when administered in combination to children with refractory cancer.
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Length of study
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Determine the incidence and severity of other toxicities
Tidsramme: Length of study
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To determine the incidence and severity of other toxicities of this combination.
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Length of study
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Seek preliminary evidence of anti-tumor activity of irinotecan plus vincristine
Tidsramme: Length of study
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To seek preliminary evidence of anti-tumor activity of irinotecan plus vincristine against recurrent solid tumors.
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Length of study
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Sylvain Baruchel, MD, The Hospital for Sick Children
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P9972
- COG-P9972 (Annen identifikator: Children's Oncology Group)
- POG-P9972 (Annen identifikator: Pediatric Oncology Group)
- CDR0000068273 (Annen identifikator: Clinical Trials.gov)
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