ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  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.

Sponsors and Collaborators: Duke University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004143
  Purpose

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.


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

Genetics Home Reference related topics:   aceruloplasminemia    breast cancer    hemophilia   

MedlinePlus related topics:   Breast Cancer    Cancer    Kidney Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Melanoma    Multiple Myeloma   

ChemIDplus related topics:   Cyclophosphamide    Filgrastim    Fludarabine    Fludarabine monophosphate    Alemtuzumab    Campath   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Allogeneic Mixed Chimerism Stem Cell Transplantation Utilizing In Vivo and In Vitro CAMPATH-1H for High Risk Diseases

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

Primary Outcome Measures:
  • Clinical disease-free survival (DFS) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment:   70
Study Start Date:   September 1999

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004143

Locations
United States, Florida
Florida Hospital Cancer Institute    
      Orlando, Florida, United States, 32804
United States, North Carolina
Duke Comprehensive Cancer Center    
      Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Investigators
Study Chair:     David A. Rizzieri, MD     Duke University    
  More Information


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

Study ID Numbers:   CDR0000067374, DUMC-1340-99-7, NCI-G99-1617
First Received:   December 10, 1999
Last Updated:   May 23, 2008
ClinicalTrials.gov Identifier:   NCT00004143
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer  
recurrent breast cancer  
refractory plasma cell neoplasm  
stage IV renal cell cancer  
recurrent renal cell cancer  
recurrent adult acute myeloid leukemia  
recurrent adult acute lymphoblastic leukemia  
relapsing chronic myelogenous leukemia  
refractory chronic lymphocytic leukemia  
stage IV melanoma  
recurrent melanoma  
polycythemia vera  
chronic idiopathic myelofibrosis  
essential thrombocythemia
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
chronic eosinophilic leukemia
chronic neutrophilic leukemia
atypical chronic myeloid leukemia
myelodysplastic/myeloproliferative disease, unclassifiable
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with t(15;17)(q22;q12)

Study placed in the following topic categories:
Polycythemia
Chronic myelogenous leukemia
Urogenital Neoplasms
Urologic Neoplasms
Preleukemia
Hemorrhagic Disorders
Multiple myeloma
Alemtuzumab
Hemorrhagic thrombocythemia
Neoplasm Metastasis
Neuroepithelioma
Thrombocythemia, Hemorrhagic
Acute myeloid leukemia, adult
Kidney Diseases
Breast Diseases
Essential thrombocytosis
Chronic lymphocytic leukemia
Myelodysplastic syndromes
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hematologic Diseases
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Blood Coagulation Disorders
Acute myelogenous leukemia
Myeloproliferative Disorders
Breast Neoplasms
Renal cancer
Leukemia, Myeloid
Multiple Myeloma
Carcinoma

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Disease
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Syndrome
Myeloablative Agonists
Nevi and Melanomas
Cardiovascular Diseases
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on October 09, 2008




Links to all studies - primarily for crawlers