NCT00718757

CompletedPhase 1

Irinotecan, Vincristine, and Dexamethasone In Children With ...

St. Jude Children's Research Hospital Source

St. Jude Children's Research Hospital

ClinicalTrials.gov

Compare

Other study identifiers

Sponsor study identifier

VIDML

Study Type

interventional

Actual enrollment (reported)

4

Locations

1 country

Sites

2

Timeline

Study Start

January 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

January 2009

Actual (reported)

Study Completion

January 2009

Actual (reported)

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) 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 4 participants
Study completion date: January 2009
Actual (reported)
Listed locations: 1 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
July 17, 2008
Actual (reported)
First Posted
July 21, 2008
Actual (reported)
Primary Completion
January 2009
Actual (reported)
Study Completion
January 2009
Actual (reported)

Last Updated: August 28, 2013
Status Verified: August 2013
Last Update Submitted: August 26, 2013

Conditions

Acute Lymphoblastic Leukemia Hodgkin's Disease Non-Hodgkins Lymphoma

Outcome Measures

Primary Outcomes (1)

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
Maximum Tolerated Dose (MTD)

Study Arms (1)

1

EXPERIMENTAL

Drug: DexamethasoneDrug: IrinotecanDrug: Vincristine

Interventions

DexamethasoneDrug

5 doses given on Days 6-10

1

IrinotecanDrug

20 mg/m2/day IV, 10 doses given on Days 1-5, 8-12

1

Eligibility Criteria

AgeUp to 21 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

St. Jude Children's Research Hospital
Otherlead

Study Sites (2)

Rady's Children Hospital San Diego

San Diego, California, 92123, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

MeSH Terms

Conditions

Lymphoma, Non-HodgkinHodgkin DiseasePrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

DexamethasoneIrinotecanVincristine

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

John T Sandlund, MD
St. Jude Children's Research Hospital
PRINCIPAL INVESTIGATOR

Enrollment

4 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 17, 2008

First Posted

July 21, 2008

Study Start

January 2005

Date type not reported

This date has not been verified as actual or estimated.

Completed

NCT00691210

Phase I Vorinostat in Combination With Niacinamide and Etoposide for Lymphoid Malignancies

Phase 1Completed

NCT00313053

Study of mAb 216 With Chemotherapy for Treatment of Pediatric Relapsed or Refractory B-progenitor Acute Lymphoblastic Leukemia

Phase 1Terminated

NCT01324180

Vincristine, Dexamethasone, Doxorubicin, and PEG-asparaginase (VPLD) and Metformin for Relapsed Childhood Acute Lymphoblastic Leukemia (ALL)

Phase 1Completed

NCT00430846

Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies

Phase 1Completed

NCT02613598

Dose Escalation Study to Determine the Maximum Tolerated Dose of the Combination of Ruxolitinib and Bortezomib in Patients With Relapsed or Refractory Lymphoma

Phase 1Completed

NCT01555853

Phase I/II Study of Abraxane in Recurrent and Refractory Lymphoma

Phase 1Terminated

VincristineDrug

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

1

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Leukemia, Lymphoid

Leukemia

Hematologic Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedCamptothecinAlkaloidsHeterocyclic CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Primary Completion

January 2009

Actual (reported)

Study Completion

January 2009

Actual (reported)

Last Updated

August 28, 2013

Record last verified: 2013-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00718757
Data provider: ClinicalTrials.gov
Source updated: 2013-08-28
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:30:04 UTC

Locations

US(2)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations