Irinotecan, Vincristine, and Dexamethasone In Children With Relapsed And/Or Refractory Hematologic Malignancies

Part of paid clinical trials in San Diego, California.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT00718757
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone — DRUG
    5 doses given on Days 6-10
  • Irinotecan — DRUG
    20 mg/m2/day IV, 10 doses given on Days 1-5, 8-12
  • Vincristine — DRUG
    1.5 mg/m2/day IV (max 2 mg), 2 doses given on Days 1,8 \* Patients \< 1 year of age or \< 10kg in weight: Vincristine 0.05 mg/kg

Study Details

The purpose of this study is to estimate the maximum tolerated dose of dexamethasone given for 5 consecutive days when combined with fixed doses of irinotecan (given IV, qd x 5, 2 days off, qd x 5) and vincristine (given IV, 2 doses total on days 1 and 8 of schedule) in children with relapsed or refractory hematologic malignancies. In addition we will also study the pharmacokinetics of irinotecan when given without and then with dexamethasone in each patient, evaluate the relationship between irinotecan pharmacokinetic parameters and toxicity and describe any antitumor effects.

Key Dates

Start date
Jan 31, 2005
Status verified
Aug 2013
Primary completion
Jan 31, 2009
Completion
Jan 31, 2009

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1

Primary Outcome Measure

Estimate the maximum tolerated dose of dexamethasone given for 5 consecutive days when combined with fixed doses of irinotecan and vincristine in children with relapsed hematologic malignancies [ Time Frame: Maximum Tolerated Dose (MTD) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Rady's Children Hospital San DiegoSan DiegoCalifornia92123-
St. Jude Children's Research HospitalMemphisTennessee38105-

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