Status:
COMPLETED
Irinotecan, Vincristine, and Dexamethasone In Children With Relapsed And/Or Refractory Hematologic Malignancies
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Non-Hodgkins Lymphoma
Hodgkin's Disease
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE1
Brief Summary
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) an...
Detailed Description
TREATMENT PLAN Treatment This is a phase I trial of irinotecan, vincristine, and dexamethasone administered over a 2-week period. Each treatment course will be a minimum of 21 days from the first day...
Eligibility Criteria
Inclusion
- Age \< or equal to 21 years at time of study entry
- Pathological diagnosis of a recurrent or refractory Non-Hodgkin's lymphoma, Hodgkin's disease, or acute lymphoblastic leukemia
- ECOG performance status \< or equal to 2 (or Lansky play-performance scale \> or equal to 50% for children \<10 years of age).
- Has not received chemotherapy in previous 2 weeks. In the case of rapidly progressing disease, this criterion may be waived by consulting with the Principal Investigator, provided the patient has recovered from the acute effects of prior therapy.
- Hemoglobin \>8 g/dl, absolute neutrophil count \>1000 /mm3 (without growth factor support), and platelet count \>50,000/mm3 (without transfusion support) unless bone marrow is involved with tumor or leukemia
- Adequate liver function (bilirubin \< 1.5 x normal for age, AST and ALT \< 3 x normal for age)
- Adequate renal function (serum creatinine \<3 x normal for age)
- No active graft-versus-host disease (GVHD) or ongoing treatment for GVHD
Exclusion
- Currently receiving other cytotoxic or investigational drugs
- Pregnant or lactating females are not eligible. Pregnancy tests must be obtained in females who are post-menarchal.
- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, azole antifungals, aprepitant, or St. John's Wort is not allowed.
- Evidence of active infection at the time of protocol entry
- History of allergy to any of the study medications
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00718757
Start Date
January 1 2005
End Date
January 1 2009
Last Update
August 28 2013
Active Locations (2)
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1
Rady's Children Hospital San Diego
San Diego, California, United States, 92123
2
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105