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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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) 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Treatments: BB 1101; Camptothecin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Irinotecan; Vincristine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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