Irinotecan, Vincristine, and Dexamethasone In Children With Relapsed And/Or Refractory Hematologic Malignancies - Full Text View

Sponsored by:	St. Jude Children's Research Hospital
Information provided by:	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00718757

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: Irintotecan Drug: Vincristine	Phase I

MedlinePlus related topics: Cancer Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Vincristine sulfate Vincristine Irinotecan Irinotecan hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I Trial Using Irinotecan, Vincristine, and Dexamethasone In Children With Relapsed And/Or Refractory Hematologic Malignancies

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 hemtologic malignancies [ Time Frame: Maximum Tolerated Dose (MTD) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	18
Study Start Date:	January 2005
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Dexamethasone 5 doses given on Days 6-10 Drug: Irintotecan 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

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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

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

Contacts

Contact: John T Sandlund, MD

1-866-278-5833

info@stjude.org

Locations

United States, California
Rady's Children Hospital San Diego	Not yet recruiting
San Diego, California, United States, 92123
Contact: Deborah E Schiff, MD
Principal Investigator: Deborah E Schiff, MD
United States, Tennessee
St. Jude Children's Research Hospital	Recruiting
Memphis, Tennessee, United States, 38105
Contact: John T Sandlund, MD 866-278-5833 info@stjude.org
Principal Investigator: John T Sandlund, MD

Sponsors and Collaborators

St. Jude Children's Research Hospital

Investigators

Principal Investigator:

John T Sandlund, MD

St. Jude Children's Research Hospital

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	St. Jude Children's Research Hospital ( John T. Sandlund, MD )
Study ID Numbers:	VIDML
Study First Received:	July 17, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00718757
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Dexamethasone
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hodgkin's disease
Hematologic Neoplasms
Hematologic Diseases
Hodgkin lymphoma, adult
Irinotecan

Lymphoma, small cleaved-cell, diffuse
Vincristine
Leukemia
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Hodgkin Disease
Dexamethasone acetate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Immune System Diseases
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics
Antimitotic Agents

Hormones
Glucocorticoids
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Autonomic Agents
Therapeutic Uses
Tubulin Modulators
Peripheral Nervous System Agents
Antineoplastic Agents, Phytogenic
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 13, 2009