Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia in Second Remission

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00002768
First received: November 1, 1999
Last updated: September 27, 2013
Last verified: September 2013
  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.

PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation following chemotherapy in treating patients with acute myeloid leukemia in second remission.


Condition Intervention Phase
Leukemia
Biological: filgrastim
Drug: busulfan
Drug: cytarabine
Drug: etoposide
Drug: methotrexate
Procedure: peripheral blood stem cell transplantation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AUTOLOGOUS STEM CELL TRANSPLANTATION FOR ACUTE MYELOID LEUKEMIA IN SECOND REMISSION: A PHASE II STUDY

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Disease free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: June 1996
Study Completion Date: March 2009
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous stem cell transplantation
Patients receive consolidation chemotherapy followed by autologous stem cell transplantation
Biological: filgrastim
10 microgram/kg body wt subcutaneously daily beginning on d 14 and con't until peripheral blood collection is completed
Other Name: G-CSF
Drug: busulfan
1 mg/kg PO q 6 hrs for 16 doses on days -7 thru -4.
Drug: cytarabine
2000 mg/ sq meter IV over 2 hours q 12 hrs x 8 doses on days 1-4
Other Name: Ara-C
Drug: etoposide
40 mg/kg (total dose) IV cont infusion over 96 hrs on days 1-4 of consolidation therapy and 60 mg/kg IV over 4 hrs on day -3 of transplant
Drug: methotrexate
For patients with documented CNS disease at first relapse, 12 mg intrathecal for a total of 6 doses given before and/or after transplantation
Procedure: peripheral blood stem cell transplantation
Infusion on Day 0

Detailed Description:

OBJECTIVES: I. Determine the ability of mobilization using cytarabine, etoposide, and filgrastim (G-CSF), conditioning using busulfan and etoposide, and autologous peripheral blood stem cell transplantation to generate a 2-year disease-free survival rate in at least 30% of patients with acute myeloid leukemia (AML) in second complete remission. II. Determine whether the treatment-related mortality can be limited to less than 20% in patients treated with this regimen. III. Determine whether adequate numbers of PBSC can be collected in these patients. IV. Determine the engraftment kinetics of primed PBSC obtained from these patients.

OUTLINE: Mobilization/harvest: Patients receive cytarabine IV over 2 hours every 12 hours and etoposide IV continuously on days 1-4. Filgrastim (G-CSF) is administered subcutaneously (SC) beginning on day 14 and continuing until peripheral blood stem cells (PBSC) are harvested. When blood counts recover, PBSC are harvested and selected for CD34+ cells. Conditioning: Beginning at least 4 weeks after hospital discharge for mobilization and harvest and when blood counts recover, patients receive oral busulfan every 6 hours on days -7 to -4 and etoposide IV over 4 hours on day -3. PBSC are reinfused on day 0. G-CSF is administered SC beginning on day 0 and continuing until blood counts recover. Patients with documented CNS disease at first relapse receive methotrexate intrathecally at intervals of 1 week or greater before and/or after PBSC transplantation for a total of 6 doses. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 26-48 patients will be accrued within 2 years.

  Eligibility

Ages Eligible for Study:   15 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Diagnosis of acute myeloid leukemia (AML) in second complete remission (CR) for 30 days to less than 1 year before study entry Second CR defined by the following: Neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Normal bone marrow morphology with no excess blasts (greater than 5%) No myelodysplasia No extramedullary or CNS leukemia Initial diagnosis of de novo AML (M0-M7) No prior myelodysplasia No myeloproliferative disease No secondary AML Cytogenetics not required No cytogenetic evidence of persistent leukemia if cytogenetics performed

PATIENT CHARACTERISTICS: Age: 15 to 69 Hematopoietic: See Disease Characteristics Granulocyte count at least 1,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST less than 3 times normal Alkaline phosphatase less than 3 times normal No cirrhosis or chronic hepatitis Biopsy required if chronic liver disease suspected (history of alcohol abuse or possible hepatitis) Renal: Creatinine less than 2.0 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow/stem cell transplantation Chemotherapy: Prior non-ablative chemotherapy at initial diagnosis, during initial remission, or as reinduction therapy (to produce current second remission) allowed At least 4 weeks since hospital discharge after reinduction therapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No prior post-remission therapy for second remission

  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: NCT00002768

Locations
United States, California
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94115-0128
United States, Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
United States, New Jersey
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States, 07503
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Charles A. Linker, MD University of California, San Francisco
  More Information

Additional Information:
Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00002768     History of Changes
Other Study ID Numbers: CDR0000064734, U10CA031946, CLB-9620
Study First Received: November 1, 1999
Last Updated: September 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Alliance for Clinical Trials in Oncology:
adult acute myeloid leukemia in remission
adult acute erythroid leukemia (M6)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myeloblastic leukemia with maturation (M2)
adult acute promyelocytic leukemia (M3)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute megakaryoblastic leukemia (M7)
adult acute monocytic leukemia (M5b)
adult acute minimally differentiated myeloid leukemia (M0)

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Busulfan
Cytarabine
Methotrexate
Etoposide
Lenograstim
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on August 27, 2014