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Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia
This study has been completed.
Sponsored by: Herbert Irving Comprehensive Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002761
  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 I/II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating patients with chronic myelogenous leukemia.


Condition Intervention Phase
Leukemia
Drug: busulfan
Drug: cyclophosphamide
Drug: cyclosporine
Drug: cytarabine
Drug: filgrastim
Drug: idarubicin
Drug: recombinant interferon gamma
Procedure: peripheral blood stem cell transplantation
Phase I
Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Cyclophosphamide Filgrastim Cytarabine Cytarabine hydrochloride Idarubicin Idarubicin hydrochloride Cyclosporin Cyclosporine Interferons Busulfan Interferon gamma-1b
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: CAMP-010: PHASE I/II STUDY OF IN VIVO PURGING FOLLOWED BY HIGH DOSE CHEMOTHERAPY, AUTOLOGOUS HEMATOPOIETIC STEM CELL INFUSION AND IMMUNOTHERAPY IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA

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

Estimated Enrollment: 43
Study Start Date: February 1996
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine whether intensive idarubicin and cytarabine leads to adequate harvest of Philadelphia chromosome-negative peripheral blood stem cells (PBSC) in patients with chronic myelogenous leukemia in chronic phase. II. Determine the toxicity of this intensive regimen in these patients. III. Determine the graft-versus-leukemia effect induced in these patients by cyclosporine and interferon gamma post-PBSC transplantation. IV. Determine the transformation-free and overall survival in patients treated with a high-dose conditioning regimen comprising busulfan and cyclophosphamide followed by PBSC transplantation plus immunotherapy.

OUTLINE: Patients receive idarubicin IV and cytarabine IV over 2 hours on days 1-3. When blood counts recover, Philadelphia chromosome negative peripheral blood stem cells (PBSC) are harvested. Filgrastim (G-CSF) is administered subcutaneously (SC) beginning 24 hours after completion of cytarabine infusion and continuing until blood counts have recovered for 3 consecutive days after harvest of PBSC. Patients with more than 5% blasts in marrow or any peripheral blasts, interferon resistance, interferon intolerance with poor prognosis, and clonal evolution proceed to conditioning followed by PBSC transplantation. Patients receive conditioning comprising oral busulfan every 6 hrs on days -8 to -5 and cyclophosphamide IV over 2 hours on days -4 and -3. PBSC are reinfused on day 0. Patients receive graft versus leukemia induction comprising cyclosporine IV over 4 hours every 12 hours on days 0-28 and interferon gamma SC beginning on day 7 and continuing every other day through day 28. Patients are followed every 3 months for 1 year and then annually for 5 years.

PROJECTED ACCRUAL: A total of 15-43 patients will be accrued for this study within 4-8 years.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Diagnosis of chronic myelogenous leukemia in first chronic phase Philadelphia chromosome-positive Myelofibrosis less than 3+ on bone marrow biopsy Ineligible for allogeneic transplantation No suitable allogeneic sibling donor OR Under 55 years old but refuses unrelated donor transplantation or no unrelated donor available

PATIENT CHARACTERISTICS: Age: 18 to physiologic 60 Performance status: ECOG 0-1 Hematopoietic: See Disease Characteristics WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2 times normal (unless elevation due to Gilbert's disease) SGOT less than 1.5 times normal Renal: Creatinine less than 1.5 times normal Cardiovascular: Left ventricular ejection fraction at least 50% Pulmonary: DLCO at least 60% predicted Other: HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior interferon alfa Chemotherapy: No concurrent conventional chemotherapy Endocrine therapy: No concurrent steroids during chemotherapy Radiotherapy: Not specified Surgery: Not specified Other: No concurrent barbiturates or acetaminophen during chemotherapy

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002761

Locations
United States, New York
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Sponsors and Collaborators
Herbert Irving Comprehensive Cancer Center
Investigators
Study Chair: Gwen L. Nichols, MD Herbert Irving Comprehensive Cancer Center
  More Information

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

Publications:
Papadopoulos KP, Nichols G: Autologous peripheral blood progenitor (PBPC) transplantation in patients with chronic myeloid leukemia. Biol Blood Marrow Transplant 4(2): A-55, 109, 1998.

Study ID Numbers: CDR0000064711, CU-CAMP-10, NCI-V96-0873
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00002761  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
relapsing chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
Philadelphia chromosome positive chronic myelogenous leukemia

Study placed in the following topic categories:
Philadelphia Chromosome
Cyclosporine
Chronic myelogenous leukemia
Interferon Type II
Clotrimazole
Hematologic Diseases
Miconazole
Interferons
Tioconazole
Myeloproliferative Disorders
Cyclophosphamide
Leukemia, Myeloid
Leukemia, Myeloid, Chronic-Phase
Cyclosporins
Leukemia
Idarubicin
Busulfan
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Bone Marrow Diseases
Cytarabine
Interferon-gamma, Recombinant

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Antifungal Agents
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Dermatologic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 14, 2009