Ecteinascidin 743 in Treating Children With Refractory Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00006463|
Recruitment Status : Completed
First Posted : April 26, 2004
Last Update Posted : February 21, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Childhood Solid Tumor, Protocol Specific||Drug: ECTEINASCIDIN 743||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of ET-743 in Pediatric Refractory Solid Tumors|
|Study Start Date :||October 2000|
|Actual Primary Completion Date :||January 2005|
|Actual Study Completion Date :||September 2005|
|Experimental: Therapy ECTEINASCIDIN 743 (1100 ug/m2 )||
Drug: ECTEINASCIDIN 743
|Experimental: ECTEINASCIDIN 743 (1300 ug/m2)||
Drug: ECTEINASCIDIN 743
- Progression Free Survival [ Time Frame: Length of study ]
- Dose Limiting ToxicityTo 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.
- Determine a safe and tolerable dose of vincristine, when administered with irinotecanTo determine a safe and tolerable dose of vincristine, when administered with irinotecan, for future evaluation in phase II clinical trials.
- Determine the pharmacokinetics of vincristine and irinotecan [ Time Frame: Length of study ]To determine the pharmacokinetics of vincristine and irinotecan (and its active metabolite SN-38) when administered in combination to children with refractory cancer.
- Determine the incidence and severity of other toxicities [ Time Frame: Length of study ]To determine the incidence and severity of other toxicities of this combination.
- Seek preliminary evidence of anti-tumor activity of irinotecan plus vincristine [ Time Frame: Length of study ]To seek preliminary evidence of anti-tumor activity of irinotecan plus vincristine against recurrent solid tumors.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006463
|Study Chair:||Sylvain Baruchel, MD||The Hospital for Sick Children|