Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	DUMC-1340-99-7 NCI-G99-1617, NCT00004143

Objectives

1. 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.
2. Determine the engraftment rate, response rate, and long term survival of patients receiving this regimen.
3. Determine the recovery of immune function post engraftment in patients treated with this regimen.
4. Determine the pharmacokinetics of cyclophosphamide administered in this regimen.
5. Assess graft-versus-tumor effects in patients treated with this regimen.

Entry 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

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

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

Expected Enrollment

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

Outcomes

Clinical disease-free survival (DFS)

Molecular complete response (CR) in patients with clinical CR/unconfirmed CR
Molecular DFS
Immunologic response against autologous tumor
Overall survival

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.

Trial Contact Information

Trial Lead Organizations

Duke Comprehensive Cancer Center

David Rizzieri, MD, Protocol chair		Ph: 919-668-1040

Registry Information
Official Title		Allogeneic Mixed Chimerism Stem Cell Transplantation Utilizing In Vivo and In Vitro CAMPATH-1H for High Risk Diseases
Trial Start Date		1999-09-21
Registered in ClinicalTrials.gov		NCT00004143
Date Submitted to PDQ		1999-11-18
Information Last Verified		2006-11-16
NCI Grant/Contract Number		CA14236

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