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Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia - Article


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Gamma Knife Treatment


Clinical Trial: Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia

This study is no longer recruiting patients.

Sponsored by: Herbert Irving Comprehensive Cancer Center
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
relapsing chronic myelogenous leukemia
Philadelphia chromosome positive chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
 Procedure: chemotherapy
 Procedure: biological response modifier therapy
 Procedure: interferon therapy
 Procedure: colony-stimulating factor therapy
 Procedure: peripheral blood stem cell transplantation
 Procedure: cytokine therapy
 Drug: graft versus tumor induction
 Drug: bone marrow ablation with stem cell support
 Drug: busulfan
 Drug: cyclophosphamide
 Drug: cyclosporine
 Drug: cytarabine
 Drug: filgrastim
 Drug: idarubicin
 Drug: interferon gamma
Phase I
Phase II

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

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I/II Study of Intensive Idarubicin and Cytarabine Followed By High-Dose Conditioning Using Busulfan and Cyclophosphamide, Autologous Peripheral Blood Stem Cell Transplantation, and Graft Versus Leukemia Induction Using Cyclosporine and Interferon gamma in Patients With Chronic Myelogenous Leukemia in First Chronic Phase

Further Study Details: 

Study start: February 1996

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.

PROTOCOL 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   -   60 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--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

--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

Location Information


New York
      Herbert Irving Comprehensive Cancer Center, New York,  New York,  10032,  United States

Study chairs or principal investigators

Gwen Lucille Nichols,  Study Chair,  Herbert Irving Comprehensive Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000064711; CU-CAMP-10; NCI-V96-0873
Record last reviewed:  November 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002761
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005


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Page Updated: October 1, 2005
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