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High Dose Chemotherapy And Autologous Peripheral Blood Stem Cell Rescue For High Risk Acute Leukemia


Phase 2
N/A
N/A
Not Enrolling
Both
Leukemia

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Trial Information

High Dose Chemotherapy And Autologous Peripheral Blood Stem Cell Rescue For High Risk 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Charles S. Hesdorffer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068386

NCT ID:

NCT00008190

Start Date:

March 1999

Completion Date:

May 2008

Related Keywords:

  • Leukemia
  • 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
  • Leukemia

Name

Location

Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032