Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Leukemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00008190
First received: January 6, 2001
Last updated: February 1, 2013
Last verified: April 2004

January 6, 2001
February 1, 2013
March 1999
November 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00008190 on ClinicalTrials.gov Archive Site
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Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Leukemia
High Dose Chemotherapy And Autologous Peripheral Blood Stem Cell Rescue For High Risk Acute Leukemia

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill leukemia cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation and interleukin-2 in treating patients who have acute leukemia.

OBJECTIVES:

  • Determine the efficacy of busulfan, cyclophosphamide, and etoposide followed by autologous peripheral blood stem cell transplantation and interleukin-2 in patients with high-risk acute leukemia.
  • Determine the efficacy of immunomodulatory therapies in terms of relapse-free survival of these patients treated with this regimen.
  • Determine the hematopoietic reconstitution, relapse, and survival of these patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: Following a course of mobilization chemotherapy, patients receive priming therapy comprising filgrastim (G-CSF) and interleukin-2 through the completion of leukapheresis. Patients then receive oral busulfan 4 times daily on days -8 through -5, cyclophosphamide IV continuously on days -4 and -3, and etoposide IV over 2 hours on day -4. For patients unable to receive cyclophosphamide and etoposide, melphalan IV is administered instead on days -3 and -2. Autologous peripheral blood stem cells (PBSC) are reinfused on day 0.

Patients then receive G-CSF daily beginning on day 0 and continuing until blood counts recover followed by interleukin-2 subcutaneously daily beginning at the completion of G-CSF therapy and continuing for 6 months.

Patients are followed weekly for 1 month and then monthly thereafter.

PROJECTED ACCRUAL: A total of 19-25 patients will be accrued for this study within 3-5 years.

Interventional
Phase 2
Primary Purpose: Treatment
Leukemia
  • Biological: aldesleukin
  • Biological: filgrastim
  • Drug: busulfan
  • Drug: cyclophosphamide
  • Drug: etoposide
  • Drug: melphalan
  • Procedure: peripheral blood stem cell transplantation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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May 2008
November 2005   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed acute leukemia

    • High-risk due to any of the following:

      • Cytogenetic abnormalities involving 5q, 7q, 8q, 11q23, or t(9;22)
      • WBC greater than 100,000/mm3
      • Prior myelodysplastic syndrome
      • Complete remission (CR) lasting less than 12 months
    • No favorable cytogenetic parameters (e.g., t(15;17), inv16, or t(8;21))
  • CR following standard anti-leukemic therapy confirmed by bone marrow evaluation

    • Second and third CR allowed
  • Ineligible for higher priority national or institutional study or allogeneic peripheral blood stem cell transplantation

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Bilirubin less than 1.5 times normal
  • SGOT or SGPT less than 1.5 times normal

Renal:

  • Creatinine less than 1.5 times normal

Cardiovascular:

  • LVEF at least 45% if receiving cyclophosphamide
  • Normal electrocardiogram OR
  • Approval by cardiologist

Pulmonary:

  • DLCO less than 60% predicted OR
  • Approval by pulmonologist

Other:

  • Not pregnant or nursing
  • No concurrent illness that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00008190
CDR0000068386, CPMC-IRB-8872, CPMC-CAMP-27, NCI-G00-1889
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Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Charles S. Hesdorffer, MD Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
April 2004

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