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

Sponsor:	Herbert Irving Comprehensive Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00008190

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 II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Cyclophosphamide Busulfan Etoposide Aldesleukin Etoposide phosphate Filgrastim Melphalan Sarcolysin Melphalan hydrochloride

U.S. FDA Resources

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

Study Start Date:	March 1999
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

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

National Cancer Institute (NCI)

Investigators

Study Chair:

Charles S. Hesdorffer, MD

Herbert Irving Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068386, CPMC-IRB-8872, CPMC-CAMP-27, NCI-G00-1889
Study First Received:	January 6, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00008190 History of Changes
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:

Anti-Infective Agents
Melphalan
Anti-HIV Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions

Leukemia
Neoplasms
Aldesleukin
Anti-Retroviral Agents
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents
Etoposide

ClinicalTrials.gov processed this record on November 27, 2009