Docetaxel in Treating Children With Relapsed or Refractory Acute Lymphoblastic or Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00021242
First received: July 11, 2001
Last updated: August 7, 2014
Last verified: August 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
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

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Response to therapy [ Time Frame: At any time during protocol therapy ] [ Designated as safety issue: No ]
    The levels of pro- and anti-apoptotic proteins will be evaluated in specimens taken before and after administration of docetaxel, at the end of therapy and at the time of relapse. The average values and variance of these levels will be used to design further investigations. The pre- and post- docetaxel levels will be compared using the difference of these two values for each patient. The change in level will be assessed using a paired t-test with an appropriate transformation for normality.


Enrollment: 12
Study Start Date: August 2002
Study Completion Date: September 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Relapsed or Refractory ALL, AML
Docetaxel 60 mg/m^2 per dose weekly (Days 1,8,15) for 3 weeks followed by 1 week of rest.
Drug: docetaxel
Continuous IV infusion
Other Names:
  • Taxotere®
  • NSC #628503

Detailed Description:

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00021242

  Show 228 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Janet Franklin, MD, MPH Children's Hospital Los Angeles
  More Information

Additional Information:
Publications:
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00021242     History of Changes
Other Study ID Numbers: ADVL0023, COG-ADVL0023, CCG-09715, CDR0000068762
Study First Received: July 11, 2001
Last Updated: August 7, 2014
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
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
Neoplasms by Histologic Type
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 22, 2014