Docetaxel in Treating Children With Relapsed or Refractory Acute Lymphoblastic or Acute Myeloid Leukemia
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Purpose
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating children who have relapsed or refractory acute lymphoblastic or acute myeloid leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: docetaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Docetaxel (Taxotere) (NSC# 628503, IND# 59,761) in Children With Refractory Leukemias |
- Response to therapy [ Designated as safety issue: No ]
| Study Start Date: | August 2002 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the response rate in pediatric patients with relapsed or refractory acute lymphoblastic or acute myeloid leukemia treated with docetaxel.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 10-20 patients will be accrued for this study within 1 year.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed acute lymphoblastic or acute myeloid leukemia
- M3 bone marrow relapse required
- Refractory to conventional chemotherapy
- No extramedullary disease at relapse
PATIENT CHARACTERISTICS:
Age:
- 21 and under at time of initial diagnosis
Performance status:
- ECOG 0-2
Life expectancy:
- At least 2 months
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- AST and ALT no greater than 1.5 times normal
- Alkaline phosphatase no greater than 2.5 times normal
Renal:
- Creatinine no greater than 1.5 times 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:
- At least 7 days since prior biologic therapy and recovered
- At least 6 months since prior allogeneic stem cell transplantation
- No concurrent immunomodulating agents during first 2 courses of therapy
- No concurrent routine filgrastim (G-CSF)
Chemotherapy:
- See Disease Characteristics
- At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered
- No prior paclitaxel or docetaxel
- No other concurrent chemotherapy during first 2 courses of therapy
Endocrine therapy:
- No concurrent corticosteroid therapy except dexamethasone, low-dose hydrocortisone to treat allergic reactions, or treatment for adrenal crisis
Radiotherapy:
- Recovered from prior radiotherapy
- At least 2 weeks since prior palliative local radiotherapy
- At least 6 months since prior craniospinal radiotherapy or radiotherapy to at least 50% of the pelvis
- At least 6 weeks since prior substantial bone marrow radiotherapy
- No concurrent radiotherapy
Surgery:
- Not specified
Contacts and Locations
Show 228 Study Locations| Study Chair: | Janet Franklin, MD, MPH | Children's Hospital Los Angeles |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00021242 History of Changes |
| Other Study ID Numbers: | CDR0000068762, COG-ADVL0023, CCG-09715 |
| Study First Received: | July 11, 2001 |
| Last Updated: | December 30, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia childhood acute promyelocytic leukemia (M3) |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms |
Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013