Gemcitabine in Treating Children With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2003 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00006462

First received: November 6, 2000

Last updated: February 17, 2009

Last verified: September 2003

History of Changes

Tracking Information

First Received Date ^ICMJE

November 6, 2000

Last Updated Date

February 17, 2009

Start Date ^ICMJE

April 2001

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00006462 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Gemcitabine in Treating Children With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia

Official Title ^ICMJE

A Phase II Study of Gemcitabine (NSC #613327) in Children With Relapsed Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating children who have relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia.

Detailed Description

OBJECTIVES:

Determine the response rate in children with relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia treated with gemcitabine.
Assess the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease histology (acute lymphoblastic leukemia vs acute myelogenous leukemia).

Patients receive gemcitabine IV over 6 hours weekly for 3 weeks. Treatment repeats every 4 weeks for a maximum of 2 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 10-20 patients will be accrued for this study.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Leukemia

Intervention ^ICMJE

Drug: gemcitabine hydrochloride

Study Arm (s)

Not Provided

Publications *

Angiolillo AL, Whitlock J, Chen Z, Krailo M, Reaman G; Children's Oncology Group. Phase II study of gemcitabine in children with relapsed acute lymphoblastic leukemia or acute myelogenous leukemia (ADVL0022): a Children's Oncology Group Report. Pediatr Blood Cancer. 2006 Feb;46(2):193-7.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Diagnosis of relapsed acute lymphoblastic leukemia or acute myelogenous leukemia
- M3 marrow (at least 25% blasts in bone marrow aspirate)
- Refractory to conventional therapy

PATIENT CHARACTERISTICS:

Age:

21 and under at diagnosis

Performance status:

ECOG 0-2 OR
Zubrod 0-2

Life expectancy:

At least 2 months

Hematopoietic:

Not specified

Hepatic:

Bilirubin normal
SGOT or SGPT no greater than 2.5 times upper limit of normal

Renal:

Creatinine normal OR
Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No concurrent immunomodulating agents

Chemotherapy:

At least 2 weeks since prior chemotherapy
No other concurrent chemotherapy for cancer

Endocrine therapy:

No concurrent corticosteroids except for treatment of adrenal crises with suppressed pituitary/adrenal response
Concurrent low-dose hydrocortisone (less than 100 mg/m2) allowed for allergic reactions to amphotericin or transfusions

Radiotherapy:

Concurrent radiotherapy to localized painful lesions allowed

Surgery:

Not specified

Other:

Recovered from any prior therapy

Gender

Both

Ages

up to 21 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Canada, Netherlands, New Zealand, Puerto Rico, Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00006462

Other Study ID Numbers ^ICMJE

CDR0000068271, COG-ADVL0022, CCG-A0999

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Children's Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Anne Angiolillo, MD

Children's Research Institute

Information Provided By

National Cancer Institute (NCI)

Verification Date

September 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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