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Pediatric Phase I and Pharmacokinetic Study of Irinotecan

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

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Trial Information

Pediatric Phase I and Pharmacokinetic Study of Irinotecan


- Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan in
children with refractory or progressive solid tumors.

- Determine the pharmacokinetics of this drug and its metabolites (SN-38, SN-38G, and
APC) administered with and without concurrent anticonvulsants in this patient

- Determine the benefit this drug offers this patient population.

OUTLINE: This is a dose-escalation, multicenter study. Patients are accrued into stratum 1
initially and into stratum 2 if stratum 1 closes due to dose-limiting toxicity of
myelosuppression or diarrhea. Patients on anticonvulsants will be accrued into stratum 3 and
must meet the eligibility criteria for the stratum that is open (stratum 1 or stratum 2).
(Stratum 1 closed as of 2002-09-15).

Patients receive irinotecan IV over 90 minutes weekly for 4 weeks. Treatment repeats every 6
weeks 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) with and without anticonvulsants is determined. The MTD is defined as the dose
preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

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

PROJECTED ACCRUAL: Approximately 20-25 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed solid tumor refractory to standard therapy
or for which no known effective therapy exists

- Brain tumors eligible

- Histologic verification waived for brain stem gliomas

- Evaluable disease

- No bone marrow involvement



- 1 to 21

Performance status:

- Karnofsky 50-100% (over age 10)

- Lansky 50-100% (age 10 and under)

Life expectancy:

- At least 8 weeks


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 8 g/dL


- Bilirubin less than 1.5 mg/dL

- SGPT less than 5 times normal


- Creatinine normal OR

- Glomerular filtration rate at least 70 mL/min


- No uncontrolled infection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study


Biologic therapy:

- At least 6 months since prior autologous bone marrow transplantation (BMT) (not
including stem cell rescue after high-dose chemotherapy)

- At least 1 week since prior growth factors

- No prior BMT with total body irradiation (stratum I)

- No prior BMT with or without total body irradiation (stratum 2)

- No prior allogeneic BMT (all strata)

- No concurrent sargramostim (GM-CSF)

- No other concurrent prophylactic growth factor support during the first course of


- At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)

- No prior irinotecan

- No more than 2 prior multi-agent chemotherapy regimens (stratum 2)

- No other concurrent chemotherapy

Endocrine therapy:

- Concurrent dexamethasone allowed if on stable or decreasing dose for at least 2 weeks
prior to study


- At least 6 months since prior craniospinal radiotherapy or radiotherapy to 50% or
more of the pelvis

- At least 6 weeks since other prior substantial bone marrow radiotherapy

- No prior central axis radiotherapy, pelvic radiotherapy, and/or total abdominal
radiotherapy (stratum 2)


- Not specified


- Recovered from all prior therapy

- No other concurrent investigational agents

- Concurrent enzyme-inducing anticonvulsants (e.g., phenytoin, phenobarbital,
carbamazepine) allowed if on stable dose for at least 2 weeks prior to study (stratum

- Concurrent valproic acid allowed if combined with another enzyme inducing
anticonvulsant drug (stratum 3)

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Susan M. Blaney, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Texas Children's Cancer Center


United States: Federal Government

Study ID:




Start Date:

September 1998

Completion Date:

January 2005

Related Keywords:

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



Texas Children's Cancer Center Houston, Texas  77030-2399