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
  Purpose

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.


Condition Intervention Phase
Leukemia
Biological: aldesleukin
Biological: filgrastim
Drug: busulfan
Drug: cyclophosphamide
Drug: etoposide
Drug: melphalan
Procedure: peripheral blood stem cell transplantation
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: High Dose Chemotherapy And Autologous Peripheral Blood Stem Cell Rescue For High Risk Acute Leukemia

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 1999
Study Completion Date: May 2008
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00008190

Locations
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Herbert Irving Comprehensive Cancer Center
Investigators
Study Chair: Charles S. Hesdorffer, MD Herbert Irving Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00008190     History of Changes
Other Study ID Numbers: CDR0000068386, CPMC-IRB-8872, CPMC-CAMP-27, NCI-G00-1889
Study First Received: January 6, 2001
Last Updated: February 1, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent childhood acute lymphoblastic leukemia
recurrent childhood acute myeloid leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
adult acute myeloid leukemia in remission
adult acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
childhood acute lymphoblastic leukemia in remission
secondary acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms
Busulfan
Cyclophosphamide
Melphalan
Aldesleukin
Etoposide
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Adjuvants, Immunologic
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 29, 2014