Clinical Trial: High-Dose Chemotherapy, Total-Body Irradiation, and Autologous Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Hematologic Cancer or Solid Tumors

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Autologous Blood and Marrow Transplantation for Hematologic Malignancy and Selected Solid Tumors

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation or autologous bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: This phase II trial is studying how well eight different high-dose chemotherapy regimens with or without total-body irradiation followed by autologous stem cell transplantation or autologous bone marrow transplantation works in treating patients with hematologic malignancies or solid tumors.


Detailed Summary:

OBJECTIVES:

  • Determine the morbidity, mortality, and overall outcome in patients with hematologic malignancies, breast cancer, or other chemosensitive solid tumors treated with disease-specific dose-intensive conditioning regimens and autologous peripheral blood or bone marrow transplantation.

OUTLINE: Patients are stratified according to risk group (standard vs high). Standard risk includes acute leukemia in first relapse or second remission; lymphoma in responding first relapse or second remission; or breast cancer at risk for recurrence. High risk includes all others. Patients receive specific conditioning regimens according to diagnosis as outlined below.

Conditioning

  • Regimen A (standard risk non-Hodgkin's lymphoma and under 60 years of age)-Etoposide, cyclophosphamide, and total body irradiation (TBI) (VCT): Patients receive etoposide IV continuously over 26 hours beginning on day -5 and cyclophosphamide IV over 2 hours on day -4. Patients undergo TBI on days -3 to -1.
  • Regimen B (any risk Hodgkin's lymphoma and under 60 years of age)-Cyclophosphamide, carmustine, and etoposide (CBV): Patients receive etoposide IV continuously over 34 hours beginning on day -8; cyclophosphamide IV over 2 hours on days -7 to -4; and carmustine IV over 2 hours on day -3.
  • Regimen C (any risk patient with prior exposure to high-dose etoposide and cyclophosphamide and under 60 years of age)-Melphalan and TBI (MEL/TBI): Patients receive melphalan IV over 30 minutes on day -4. Patients undergo TBI on days -3 to -1.
  • Regimen D (multiple myeloma or amyloidosis)-Melphalan only
    Sponsor: Roswell Park Cancer Institute

    Current Primary Outcome:

    • Morbidity [ Time Frame: +day 100 ]
    • Mortality [ Time Frame: +day 100, +day 360 ]
    • Overall outcome [ Time Frame: every 6 months until death ]
    • Response rate [ Time Frame: +day 100, +day 360 ]
    • Toxicity [ Time Frame: +day100, +day 360 ]
    • Disease-free survival [ Time Frame: up to 15years ]
    • Overall survival [ Time Frame: every 6 months until death ]


    Original Primary Outcome:

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Roswell Park Cancer Institute

    Dates:
    Date Received: May 6, 2003
    Date Started: December 1991
    Date Completion:
    Last Updated: May 7, 2013
    Last Verified: May 2013