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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
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


- 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

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


- 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



- 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


- 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)


- Bilirubin no greater than 1.5 times normal for age

- SGPT less than 5 times normal for age

- Albumin at least 2 g/dL


- 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


- 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


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


- 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


- 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


- Not specified


- No other concurrent investigational agent

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Albert Moghrabi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Hopital Sainte Justine


United States: Federal Government

Study ID:




Start Date:

October 2000

Completion Date:

Related Keywords:

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



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