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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00718757
First received: July 17, 2008
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Non-Hodgkins Lymphoma
Hodgkin's Disease
Acute Lymphoblastic Leukemia
Drug: Dexamethasone
Drug: Irinotecan
Drug: Vincristine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Trial Using Irinotecan, Vincristine, and Dexamethasone In Children With Relapsed And/Or Refractory Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: January 2005
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Dexamethasone
5 doses given on Days 6-10
Drug: Irinotecan
20 mg/m2/day IV, 10 doses given on Days 1-5, 8-12
Drug: Vincristine

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


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718757

Locations
United States, California
Rady's Children Hospital San Diego
San Diego, California, United States, 92123
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: John T Sandlund, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00718757     History of Changes
Other Study ID Numbers: VIDML
Study First Received: July 17, 2008
Last Updated: August 26, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hodgkin Disease
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma
Lymphoma, Non-Hodgkin
Hematologic Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Hematologic Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Irinotecan
Vincristine
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 28, 2014