Clinical Trial: Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Advanced Hematologic Cancer

This study is currently recruiting patients.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
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 bone marrow 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 busulfan and melphalan followed by donor bone marrow transplantation in treating patients who have advanced hematologic cancer.

Condition Treatment or Intervention Phase
acute leukemia
atypical chronic myeloid leukemia
chronic leukemia
Graft Versus Host Disease
myelodysplastic and myeloproliferative disease
 Drug: busulfan
 Drug: melphalan
 Drug: methotrexate
 Drug: tacrolimus
 Procedure: allogeneic bone marrow transplantation
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: bone marrow transplantation
 Procedure: chemotherapy
 Procedure: graft versus host disease prophylaxis/therapy
 Procedure: supportive care/therapy
Phase II

MedlinePlus related topics:  Blood and Blood Disorders;   Cancer;   Cancer Alternative Therapy;   Immune System and Disorders;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Busulfan and Melphalan Followed by Allogeneic Bone Marrow Transplantation in Patients With Advanced or High-Risk Hematologic Malignancy

Further Study Details: 

OBJECTIVES:

OUTLINE: Patients receive cytoreductive chemotherapy comprising busulfan IV over 2 hours every 6 hours for a total of 16 doses on days -8 to -5 and melphalan IV over 30 minutes on days -4 to -2. Patients undergo T-cell replete allogeneic bone marrow transplantation on day 0. For graft-versus-host disease prophylaxis, patients receive tacrolimus IV continuously or every 12 hours beginning on day -1 and continuing for 50 days to 6 months followed by a taper. Once oral medications are tolerated, patients switch to oral tacrolimus every 12 hours. Patients also receive methotrexate IV on days 1, 3, 6, and 11.

Patients are followed weekly through day 100, every 6 weeks for 3 months, every 3 months for 1 year, and then every 3-6 months for 6 months.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 3 years.

Eligibility

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age:

  • Under 60 (over 60 considered on case-by-case basis)

Performance status:

  • Karnofsky 70-100%
  • Lansky 70-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • AST and ALT less than 2 times upper limit of normal
  • Bilirubin less than 1.5 mg/dL unless liver is involved with disease

Renal:

  • Creatinine normal
  • Creatinine clearance greater than 60 mL/min

Cardiovascular:

  • Asymptomatic with no prior risk factors OR
  • LVEF greater than 50% if symptomatic

Pulmonary:

  • Asymptomatic with no prior risk factors OR
  • Diffusion capacity greater than 50% predicted (corrected for hemoglobin) if symptomatic

Other:

  • No active uncontrolled viral, bacterial, or fungal infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy:

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • Not specified

Location and Contact Information


New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
Esperanza B. Papadopoulos, MD  212-639-8276    papadope@mskcc.org 

Study chairs or principal investigators

Trudy Small, MD,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

More Information

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

Study ID Numbers:  CDR0000068546; MSKCC-00126; NCI-H01-0070; NCT00014469
Record last reviewed:  December 2001
Last Updated:  December 6, 2004
Record first received:  April 10, 2001
ClinicalTrials.gov Identifier:  NCT00014469
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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