Full Text View
Tabular View
No Study Results Posted
Related Studies
Peripheral Stem Cell Transplant Plus Monoclonal Antibody Therapy in Treating Patients With High-Risk Hematologic Cancer, Refractory Breast or Kidney Cancer, or Melanoma
This study is ongoing, but not recruiting participants.
Study NCT00004143   Information provided by National Cancer Institute (NCI)
First Received: December 10, 1999   Last Updated: February 6, 2009   History of Changes

December 10, 1999
February 6, 2009
September 1999
 
Clinical disease-free survival (DFS) [ Designated as safety issue: No ]
Clinical disease-free survival (DFS)
Complete list of historical versions of study NCT00004143 on ClinicalTrials.gov Archive Site
  • Molecular complete response (CR) in patients with clinical CR/unconfirmed CR [ Designated as safety issue: No ]
  • Molecular DFS [ Designated as safety issue: No ]
  • Immunologic response against autologous tumor [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Molecular complete response (CR) in patients with clinical CR/unconfirmed CR
  • Molecular DFS
  • Immunologic response against autologous tumor
  • Overall survival
 
Peripheral Stem Cell Transplant Plus Monoclonal Antibody Therapy in Treating Patients With High-Risk Hematologic Cancer, Refractory Breast or Kidney Cancer, or Melanoma
Allogeneic Mixed Chimerism Stem Cell Transplantation Utilizing In Vivo and In Vitro CAMPATH-1H for High Risk Diseases

RATIONALE: Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving a monoclonal antibody, alemtuzumab, at the time of transplant may stop this from happening.

PURPOSE: This phase II trial is studying peripheral stem cell transplant 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.

OBJECTIVES:

  • Determine the efficacy, in terms of mortality, occurrence of acute graft versus-host-disease, and grade 3/4 toxicity, of in vivo and in vitro alemtuzumab (monoclonal antibody CD52; Campath-1H) administered concurrently with nonmyeloablative fludarabine and cyclophosphamide, followed by HLA identical matched sibling allogeneic peripheral blood stem cell transplantation in patients with hematologic malignancies or refractory breast or renal cell cancer or melanoma.
  • Determine the engraftment rate, response rate, and long term survival of patients receiving this regimen.
  • Determine the recovery of immune function post engraftment in patients treated with this regimen.
  • Determine the pharmacokinetics of cyclophosphamide administered in this regimen.
  • Assess graft-versus-tumor effects in patients treated with this regimen.

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.

Phase II
Interventional
Treatment
  • Breast Cancer
  • Chronic Myeloproliferative Disorders
  • Kidney Cancer
  • Leukemia
  • Melanoma (Skin)
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • Biological: alemtuzumab
  • Biological: filgrastim
  • Drug: cyclophosphamide
  • Drug: fludarabine phosphate
  • Procedure: in vitro-treated peripheral blood stem cell transplantation
  • Procedure: peripheral blood stem cell transplantation
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
70
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004143
 
CDR0000067374, DUMC-1340-99-7, NCI-G99-1617
Duke University
National Cancer Institute (NCI)
Study Chair: David A. Rizzieri, MD Duke University
National Cancer Institute (NCI)
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP