|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005948 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Biological: aldesleukin Biological: recombinant interferon alfa Biological: sargramostim Drug: busulfan Procedure: peripheral blood stem cell transplantation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| 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 Start Date: | January 2000 |
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.
Eligibility| Ages Eligible for Study: | up to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Colorado | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80010 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Study Chair: | Leona A. Holmberg, MD, PhD | Fred Hutchinson Cancer Research Center |
More Information
| Study ID Numbers: | CDR0000067877, FHCRC-1455.00, NCI-G00-1792 |
| Study First Received: | July 5, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00005948 History of Changes |
| Health Authority: | United States: Federal Government |
|
relapsing chronic myelogenous leukemia chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia |
|
Interferon-alpha Interferon Type I, Recombinant Anti-HIV Agents Immunologic Factors Hematologic Diseases Interferons Myeloproliferative Disorders Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase Immunosuppressive Agents Angiogenesis Inhibitors Antiviral Agents |
Leukemia Aldesleukin Anti-Retroviral Agents Leukemia, Myeloid, Accelerated Phase Busulfan Leukemia, Myelogenous, Chronic, BCR-ABL Positive Antineoplastic Agents, Alkylating Chronic Myelogenous Leukemia Bone Marrow Diseases Interferon Alfa-2a Alkylating Agents |
|
Anti-Infective Agents Interferon Type I, Recombinant Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Leukemia Anti-Retroviral Agents Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Alkylating Agents Interferon-alpha Anti-HIV Agents Neoplasms by Histologic Type |
Hematologic Diseases Growth Substances Interferons Myeloproliferative Disorders Leukemia, Myeloid Immunosuppressive Agents Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Aldesleukin Busulfan Myeloablative Agonists Leukemia, Myelogenous, Chronic, BCR-ABL Positive Antineoplastic Agents, Alkylating |
