Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2003-12-31

Brief Summary

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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and irinotecan in treating children who have refractory solid tumors.

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Detailed Description

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OBJECTIVES:

* Determine the maximum tolerated dose and recommended phase II dose of carboplatin and irinotecan in children with refractory solid tumors.
* Determine the safety profile and dose-limiting toxic effects of this regimen in these patients.
* Determine the pharmacokinetics of this regimen in these patients.
* Determine the preliminary anti-tumor activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of carboplatin and irinotecan.

Patients receive carboplatin IV over 50 minutes on day 1 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of carboplatin and irinotecan until the maximum tolerated dose (MTD) is determined. 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 for at least 30 days.

PROJECTED ACCRUAL: A total of 25-30 patients will be accrued for this study within 6-9 months.

Conditions

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Unspecified Childhood Solid Tumor, Protocol Specific

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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carboplatin

Intervention Type DRUG

irinotecan hydrochloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed solid tumor, including primary brain tumor

* Progressive disease on standard therapy or for which no standard therapy exists
* No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age:

* 1 to 21

Performance status:

* Lansky 50-100% (age 10 and under)
* Karnofsky 50-100% (over age 10)

Life expectancy:

* At least 8 weeks

Hematopoietic:

* Absolute neutrophil count greater than 1,000/mm3
* Platelet count greater than 100,000/mm3

Hepatic:

* Bilirubin no greater than 1.5 mg/dL
* ALT no greater than 2.5 times upper limit of normal

Renal:

* Glomerular filtration rate at least 30 mL/min

Other:

* No active infection
* No serious uncontrolled medical disorder
* No psychiatric disorder or other disorder that would preclude study
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 6 months since prior allogeneic bone marrow transplantation without evidence of acute or chronic graft versus host disease
* At least 3 months since prior autologous bone marrow or peripheral blood stem cell transplantation
* At least 4 weeks since prior immunotherapy and recovered
* No concurrent immunotherapy

Chemotherapy:

* No more than 3 prior chemotherapy regimens
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
* No other concurrent chemotherapy

Endocrine therapy:

* Concurrent hormone replacement therapy or oral contraceptives allowed
* No other concurrent hormonal therapy

Radiotherapy:

* At least 4 weeks since prior radiotherapy (including for brain metastases) and recovered
* No concurrent radiotherapy

Surgery:

* Not specified

Other:

* No other concurrent investigational anticancer drugs
* No other concurrent antitumor therapy
* No concurrent anticonvulsants (e.g., phenytoin, phenobarbital, or carbamazepine) except gabapentin (Neurontin)

Minimum Eligible Age

1 Year

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No