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Chemotherapy Followed by Peripheral Stem Cell Transplantation And Biological Therapy in Treating Patients With Chronic Myelogenous Leukemia

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
recombinant interferon alfa
sargramostim
busulfan
peripheral blood stem cell transplantation
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Chronic myelogenous leukemia with previously stored CD34 cells from FHCRC-928.00 Chronic phase: No evidence of a major response after 6-month course of interferon alfa OR Initially achieved a major cytogenetic response but subsequently failed interferon alfa OR Accelerated phase: At least 1 month after collection of peripheral blood stem cells No blast crisis No CNS involvement Ineligible for or refused allogeneic conventional or minitransplant protocol PATIENT CHARACTERISTICS: Age: 70 and under Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL (unless history of Gilbert's disease) AST or ALT no greater than 2.5 times upper limit of normal No cirrhosis Hepatitis B and C negative Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No myocardial infarction within past 12 months No unstable angina, poorly controlled arrhythmias, or hypertension LVEF greater than 50% Pulmonary: DLCO at least 50% Alveolar arterial gradient less than 30 at sea level Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No active infection requiring systemic antibiotics No known allergy to gentamicin or murine or E. coli proteins or documented prior anaphylactic reaction to sargramostim (GM-CSF) or interleukin-2 PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: Not specified Endocrine therapy: No concurrent ongoing steroids Radiotherapy: Not specified Surgery: Not specified

Sites / Locations

  • University of Colorado Cancer Center
  • Fred Hutchinson Cancer Research Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 5, 2000
Last Updated
March 31, 2010
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005948
Brief Title
Chemotherapy Followed by Peripheral Stem Cell Transplantation And Biological Therapy in Treating Patients With Chronic Myelogenous Leukemia
Official Title
A Pilot Study of High Dose Busulfan Combined With IL2/GM-CSF Activated Autologous/Syngeneic PBSC, Sequential IL2/GM-CSF Therapy and Alpha Interferon Maintenance Therapy as Treatment of CML
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
October 2001 (Actual)
Study Completion Date
October 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation and biological therapy in treating patients who have chronic myelogenous leukemia.
Detailed Description
OBJECTIVES: I. Determine the toxicity of high-dose busulfan followed by interleukin-2 (IL-2) and sargramostim (GM-CSF) activated autologous/syngeneic peripheral blood stem cell (PBSC) transplantation, sequential IL-2 and GM-CSF therapy, and interferon alfa in patients with chronic myelogenous leukemia. II. Determine engraftment potential of IL-2/GM-CSF activated PBSC followed by sequential IL-2/GM-CSF therapy in this patient population. III. Assess the time to cytogenetic and/or morphologic relapse, overall event-free survival, and overall survival in these patients treated with this regimen. OUTLINE: Autologous peripheral blood stem cells (PBSC) are harvested and activated with interleukin-2 (IL-2) and sargramostim (GM-CSF) on another protocol. Patients receive oral busulfan every 6 hours on days -6 to -3 for a total of 16 doses. IL-2 and GM-CSF-activated PBSC are reinfused on day 0. Beginning 4 hours after PBSC infusion, patients receive IL-2 IV continuously for 5 days followed by 2 days of rest for 4 weeks. In addition, GM-CSF is administered subcutaneously (SC) every Monday, Wednesday, and Friday for 4 weeks. Upon hematologic recovery, but no earlier than 2 weeks after IL-2 and GM-CSF, patients receive interferon alfa SC 3 times weekly until clear evidence of disease progression. Patients are followed every 6 months for 3 years and then annually thereafter. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2-3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa
Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Type
Drug
Intervention Name(s)
busulfan
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation

10. Eligibility

Sex
All
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Chronic myelogenous leukemia with previously stored CD34 cells from FHCRC-928.00 Chronic phase: No evidence of a major response after 6-month course of interferon alfa OR Initially achieved a major cytogenetic response but subsequently failed interferon alfa OR Accelerated phase: At least 1 month after collection of peripheral blood stem cells No blast crisis No CNS involvement Ineligible for or refused allogeneic conventional or minitransplant protocol PATIENT CHARACTERISTICS: Age: 70 and under Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL (unless history of Gilbert's disease) AST or ALT no greater than 2.5 times upper limit of normal No cirrhosis Hepatitis B and C negative Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No myocardial infarction within past 12 months No unstable angina, poorly controlled arrhythmias, or hypertension LVEF greater than 50% Pulmonary: DLCO at least 50% Alveolar arterial gradient less than 30 at sea level Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No active infection requiring systemic antibiotics No known allergy to gentamicin or murine or E. coli proteins or documented prior anaphylactic reaction to sargramostim (GM-CSF) or interleukin-2 PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: Not specified Endocrine therapy: No concurrent ongoing steroids Radiotherapy: Not specified Surgery: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leona A. Holmberg, MD, PhD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Colorado Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Chemotherapy Followed by Peripheral Stem Cell Transplantation And Biological Therapy in Treating Patients With Chronic Myelogenous Leukemia

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