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Temozolomide in Treating Young Patients With Refractory or Recurrent Leukemia



Temozolomide in Treating Young Patients With Refractory or Recurrent Leukemia

For Condition: recurrent childhood acute lymphoblastic leukemia,relapsing chronic myelogenous leukemia,blastic phase chronic myelogenous leukemia,childhood chronic myelogenous leukemia,recurrent childhood acute myeloid leukemia,childhood acute promyelocytic leukemia (M3)
Status: Not yet recruiting
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as temozolomide work in different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of temozolomide in treating young patients who have refractory or recurrentleukemia.
Details: OBJECTIVES: Primary - Determine the maximum tolerated dose and recommended phase II dose of temozolomide in pediatric patients with refractory or recurrent leukemia. - Determine the toxic effects of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. Secondary - Determine the antitumor activity of this drug in these patients. - Determine the biologic activity and mechanism(s) of resistance to this drug in these patients. OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients are stratified according to disease status (refractory vs recurrent). Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 18-24 months.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 1 Year/21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed leukemia of any of the following types: - Acute lymphoblastic leukemia - Acute myeloid leukemia - Chronic myelogenous leukemia in blast crisis - Refractory or recurrent disease - Immunophenotypic confirmation of disease at initial diagnosis or recurrence - More than 25% blasts in the bone marrow (M3) - Active extramedullary disease allowed except for leptomeningeal disease - No known curative therapy or therapy proven to prolong survival with an acceptable quality of life - No active CNS disease PATIENT CHARACTERISTICS: Age - 1 to 21 Performance status - Karnofsky 50-100% (for patients > 10 years of age) - Lansky 50-100% (for patients 10 years of age) Life expectancy - Not specified Hematopoietic - WBC < 100,000/mm^3 (hydroxyurea allowed) - Platelet count 20,000/mm^3 (platelet transfusions allowed) - Hemoglobin 8.0 g/dL (red blood cell transfusions allowed) Hepatic - ALT 5 times upper limit of normal (ULN) - Albumin 2 g/dL - Bilirubin 1.5 times ULN Renal - Creatinine normal for age OR - Creatinine clearance OR radioisotope glomerular filtration rate 70 mL/min Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy - Recovered from prior immunotherapy - At least 7 days since prior hematopoietic growth factors - At least 7 days since prior biologic therapy - At least 3 months since prior stem cell transplantation - No evidence of active graft-vs-host disease - No concurrent biologic therapy - No concurrent immunotherapy Chemotherapy - Recovered from prior chemotherapy - At least 6 weeks since prior nitrosoureas - Prior cytoreductive therapy with hydroxyurea allowed for up to 24 hours before initiation of study drug - No other concurrent chemotherapy Endocrine therapy - More than 7 days since prior steroids except as premedication for blood products in patients with prior severe allergic reactions - Concurrent hydrocortisone or methylprednisolone ( 2 mg/kg) allowed as premedication for blood products in patients with prior severe allergic reactions Radiotherapy - Recovered from prior radiotherapy - At least 2 weeks since prior local palliative radiotherapy (small port) - At least 6 months since prior total body irradiation or craniospinal radiotherapy - At least 6 months since prior radiotherapy to 50% of the pelvis - At least 6 weeks since other prior substantial bone marrow radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - No other concurrent anticancer agents - No other concurrent investigational drugs
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
TerzahHorton,  Study Chair,  Texas Children's Cancer Center


Additional Information:
Study ID Numbers:  CDR0000362059;  COG-ADVL0411
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083070

Other Childhood Acute Promyelocytic Leukemia (m3) Studies:
1. Filgrastim-Treated Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemia

2. Decitabine in Treating Children With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

3. STI571 in Treating Patients With Recurrent Leukemia

4. Combination Chemotherapy Plus PSC-833 in Treating Children With Refractory or Relapsed Acute Leukemia

5. Diagnostic Study of Gene Alterations in Children Who Have Been Treated for Relapsed Acute Lymphocytic Leukemia

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