Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 21 and under at diagnosis NCI COG-ADVL0022 CCG-A0999, NCT00006462

Objectives

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

Entry Criteria

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

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

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

Expected Enrollment

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

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.

Angiolillo AL, Whitlock J, Chen Z, et al.: 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 46 (2): 193-7, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Anne Angiolillo, MD, Protocol chair		Ph: 202-476-5000

Registry Information
Official Title		A Phase II Study of Gemcitabine (NSC #613327) in Children with Relapsed Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia
Trial Start Date		2001-04-30
Registered in ClinicalTrials.gov		NCT00006462
Date Submitted to PDQ		2000-09-05
Information Last Verified		2003-09-08
NCI Grant/Contract Number		U10-CA13539

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