Clinical Trial: Peripheral Stem Cell Transplantation Plus Monoclonal Antibody Therapy in Treating Patients With High-Risk Hematologic Cancer, Refractory Breast or Kidney Cancer, or Melanoma

This study is currently recruiting patients.

Sponsors and Collaborators: Duke Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Peripheral stem cell transplantation replaces immune cells that were destroyed by chemotherapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Treatment of the cells with a monoclonal antibody may prevent this from happening.

PURPOSE: This phase II trial is studying peripheral stem cell transplantation and monoclonal antibody therapy to see how well they work in treating patients with high-risk hematologic cancer, refractory breast or kidney cancer, or melanoma.

Condition Treatment or Intervention Phase
Breast Cancer
hematopoietic and lymphoid cancer
kidney and urinary cancer
skin tumor
 Drug: alemtuzumab
 Drug: cyclophosphamide
 Drug: filgrastim
 Drug: fludarabine
 Procedure: antibody therapy
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: in vitro-treated peripheral blood stem cell transplantation
 Procedure: monoclonal antibody therapy
 Procedure: peripheral blood stem cell transplantation
Phase II

MedlinePlus related topics:  Breast Cancer;   Skin Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Allogeneic Mixed Chimerism Peripheral Blood Stem Cell Transplantation Utilizing In Vivo and In Vitro Alemtuzumab (Monoclonal Antibody CD52; Campath-1H) in Patients With High-Risk Hematologic Malignancies or Refractory Breast or Renal Cell Cancer or Melanoma

Further Study Details: 

OBJECTIVES:

OUTLINE: Patients receive alemtuzumab (monoclonal antibody CD52; Campath-1H) IV over 3 hours on days -6 to -2 and fludarabine IV over 30 minutes and cyclophosphamide IV over 1 hour on days -5 to -2. Allogeneic peripheral blood stem cells and alemtuzumab are infused on days 0 and 1. Filgrastim (G-CSF) is administered subcutaneously beginning on day 1 and continuing until blood counts recover.

Patients are followed daily until day 60, twice a week until day 100, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 3 years.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of any one of the following:
  • Relapsed or refractory hematologic malignancy
  • Acute myeloid leukemia
  • Chronic myeloid leukemia
  • Acute lymphocytic leukemia
  • Chronic lymphocytic leukemia
  • Multiple myeloma
  • Myeloproliferative or myelodysplastic disorders
  • Not eligible for full myeloablative matched sibling transplant
  • Bone marrow failure
  • Severe or very severe aplastic anemia
  • Myelofibrosis or paroxysmal nocturnal hemoglobinuria
  • Increased blast cells (at least 5%) in peripheral blood or bone marrow OR
  • Visceral organ damage due to disease
  • Severe fibrosis of bone marrow
  • Severe Budd-Chiari
  • Mild hepatic/portal clot by ultrasound or hepatic biopsy
  • Drug induced marrow aplasia
  • Hemoglobinopathies
  • Severe sickle cell anemia
  • Thalassemia with cardiac or hepatic damage
  • Solid tumor with metastatic disease and failed at least 1 standard regimen
  • Breast cancer
  • Progressed after doxorubicin and cyclophosphamide
  • Renal cell cancer
  • Failed interleukin-2 therapy
  • Melanoma
  • Failed interleukin-2 therapy
  • Must have 6/6 HLA matched sibling donor
  • Hormone receptor status:
  • Not specified

PATIENT CHARACTERISTICS: Age:

  • 18 and over

Sex:

  • Not specified

Menopausal status:

  • Not specified

Performance status:

  • CALGB 0-2

Life expectancy:

  • At least 6 weeks

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • Ejection fraction greater than 40%

Pulmonary:

  • DLCO greater than 40%

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other major medical or psychiatric illness that would preclude compliance
  • No allergy to murine protein
  • HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • See Disease Characteristics
  • Recovered from prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Recovered from prior radiotherapy

Surgery:

  • Not specified

Location and Contact Information


Florida
      Florida Hospital Cancer Institute, Orlando,  Florida,  32804,  United States; Recruiting
John Edwards, MD  407-303-2070    john.edwards.md@flhosp.org 

North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States; Recruiting
David A. Rizzieri, MD  919-668-1040 

Study chairs or principal investigators

David A. Rizzieri, MD,  Study Chair,  Duke Comprehensive Cancer Center   

More Information

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

Study ID Numbers:  CDR0000067374; DUMC-1340-99-7; NCI-G99-1617; NCT00004143
Record last reviewed:  November 2004
Last Updated:  February 24, 2005
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004143
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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