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A Phase I Study of Irinotecan in Patients With Refractory Solid Tumors Who Are Concomitantly Receiving Anticonvulsants


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

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Trial Information

A Phase I Study of Irinotecan in Patients With Refractory Solid Tumors Who Are Concomitantly Receiving Anticonvulsants


OBJECTIVES:

- Determine the maximum tolerated dose of irinotecan in children with refractory or
advanced solid tumors receiving anticonvulsants.

- Determine the dose-limiting toxicity of irinotecan in this patient population.

- Evaluate the pharmacokinetic behavior of this treatment regimen in these patients.

- Determine, preliminarily, the antitumor activity of this treatment regimen in these
patients.

OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to
type of concurrent anticonvulsant (enzyme activating anticonvulsants vs valproic acid vs
other anticonvulsants).

Patients receive irinotecan IV over 1 hour daily for 5 days. Treatment repeats every 21 days
in the absence of disease progression or unacceptable toxicity.

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

Patients are followed every 6 months for up to 4 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 3-25 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed malignancy refractory to conventional therapy or for which
no conventional therapy exists

- Histologic confirmation not required for brain stem tumors

- Concurrently on anticonvulsants at a steady level for at least 2 weeks

PATIENT CHARACTERISTICS:

Age:

- 1-21 years old

Performance status:

- Karnofsky 50-100% (over 10 years of age)

- Lansky 50-100% (10 years of age or under)

Life expectancy:

- At least 8 weeks

Hematopoietic:

- Neutrophil count at least 1,000/mm3

- Platelet count at least 100,000/mm3 (transfusion independent)

- Hemoglobin at least 8.0 g/dL (red blood cell transfusions allowed)

Hepatic:

- Bilirubin no greater than 1.5 times normal for age

- SGPT less than 5 times normal for age

- Albumin at least 2 g/dL

Renal:

- Creatinine no greater than 1.5 times normal for age OR

- Creatinine clearance or radioisotope glomerular filtration rate at least lower limit
of normal for age

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No uncontrolled infection

- No evidence of active graft-vs-host disease

- Neurologic deficits for CNS tumors stable for at least 2 weeks prior to study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 1 week since prior antineoplastic biologic therapy

- At least 6 months since prior allogeneic stem cell transplantation

- At least 1 week since prior growth factors

- No concurrent sargramostim (GM-CSF)

- No concurrent prophylactic growth factors during first course of study therapy

- Recovered from prior immunotherapy

Chemotherapy:

- At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosourea)
and recovered

Endocrine therapy:

- Concurrent dexamethasone for CNS tumors with increased intracranial pressure allowed
if dose stable or decreasing for at least 2 weeks prior to study

Radiotherapy:

- At least 2 weeks since prior local palliative radiotherapy (small part)

- At least 6 months since prior craniospinal radiotherapy

- At least 6 months since prior radiotherapy to at least 50% of pelvis

- At least 6 weeks since prior substantial bone marrow radiotherapy

- Recovered from prior radiotherapy

Surgery:

- Not specified

Other:

- No other concurrent investigational agent

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Albert Moghrabi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Hopital Sainte Justine

Authority:

United States: Federal Government

Study ID:

CDR0000068410

NCT ID:

NCT00008424

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
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Simmons Cancer Center - DallasDallas, Texas  75235-9154
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-Ingram Cancer CenterNashville, Tennessee  37232-6838
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Boston Floating Hospital Infants and ChildrenBoston, Massachusetts  02111
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
CCOP - Green BayGreen Bay, Wisconsin  54301
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Cancer Center and Beckman Research Institute, City of HopeDuarte, California  91010-3000
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 Hospital of DenverDenver, Colorado  80218
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