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

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ClinicalTrials.gov Identifier: NCT00060255
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : May 9, 2013
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Description
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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.


Condition or disease Intervention/treatment Phase
Breast Cancer Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Testicular Germ Cell Tumor Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific Drug: busulfan Drug: carboplatin Drug: carmustine Drug: cyclophosphamide Drug: etoposide Drug: melphalan Drug: thiotepa Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy Phase 2

Detailed Description:

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 (MEL only): Patients receive melphalan IV over 30 minutes on day -2.
  • Regimen E (any patient unable to receive TBI)-Busulfan and cyclophosphamide: Patients receive oral busulfan (or busulfan IV over 2 hours) on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.
  • Regimen F (any risk breast cancer)-Cyclophosphamide, carboplatin, and thiotepa (STAMP V): Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4.
  • Regimen G (solid tumors other than breast or testicular cancer)-Thiotepa and carboplatin (TT/CARBO): Patients receive thiotepa IV over 2 hours on days -6 and -5 and carboplatin IV continuously over 96 hours beginning on day -6.
  • Regimen H (recurrent or primary progressive testicular cancer)-Etoposide and carboplatin (VP/CARBO): Patients receive etoposide IV over 2 hours and carboplatin IV over 30 minutes on days -6 to -4.

Stem Cell Infusion

  • In all regimens, patients undergo autologous stem cell infusion on day 0. Treatment continues in the absence of unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 450 patients (50 patients [25 per stratum] per regimen) will be accrued for this study within 10 years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 451 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Blood and Marrow Transplantation for Hematologic Malignancy and Selected Solid Tumors
Study Start Date : December 1991
Actual Primary Completion Date : August 2006
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Drug: busulfan
    iv
  • Drug: carboplatin
    iv
  • Drug: carmustine
    iv
  • Drug: cyclophosphamide
    iv
  • Drug: etoposide
    iv
  • Drug: melphalan
    oral
  • Drug: thiotepa
    iv
  • Procedure: autologous bone marrow transplantation
    iv
  • Procedure: bone marrow ablation with stem cell support
    iv
  • Procedure: peripheral blood stem cell transplantation
    iv
  • Radiation: radiation therapy
    body x-ray

Outcome Measures
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Primary Outcome Measures :
  1. Morbidity [ Time Frame: +day 100 ]
  2. Mortality [ Time Frame: +day 100, +day 360 ]
  3. Overall outcome [ Time Frame: every 6 months until death ]
  4. Response rate [ Time Frame: +day 100, +day 360 ]
  5. Toxicity [ Time Frame: +day100, +day 360 ]
  6. Disease-free survival [ Time Frame: up to 15years ]
  7. Overall survival [ Time Frame: every 6 months until death ]

Eligibility Criteria
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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed hematologic or solid tumor malignancy, including any of the following:

    • Acute myeloid leukemia

      • First remission and not eligible for allogeneic transplantation; recurrent disease after combination chemotherapy with at least 1 standard regimen; or second remission
      • Not eligible for protocol CLB-9620 or CLB-9621

    • Acute lymphoblastic leukemia

      • First complete remission without appropriate allogeneic donor

    • Chronic myelogenous leukemia

      • Chronic, accelerated, or blast phase

    • Lymphoproliferative diseases*

      • Chronic lymphocytic leukemia
      • Multiple myeloma
      • Waldenstrom's macroglobulinemia
      • Low-grade non-Hodgkin's lymphoma (NHL) NOTE: *Recurrent or persistent, symptomatic disease after first-line chemotherapy, or subsequently

    • Amyloidosis

      • Primary or previously treated disease

    • NHL (intermediate- and high-grade)

      • Resistant or recurrent disease after combination chemotherapy with at least 1 standard regimen

      • First remission lymphoblastic or small, non-cleaved cell lymphoma at high risk of relapse

        • CNS disease OR bone marrow disease and lactic dehydrogenase greater than 300 IU/L

    • Hodgkin's lymphoma

      • Resistant or recurrent disease after combination chemotherapy with at least 1 standard regimen

    • Solid tumors

      • High-risk and metastatic breast cancer
      • Testicular cancer that has relapsed OR primary progressive disease that is responding to salvage therapy
      • Other solid tumors that have recurred after conventional therapy OR are at high risk for relapse, and demonstrate chemosensitivity
  • Less than 10% marrow tumor present histologically (maximum of 15% involvement allowed if purged)

  • Allogeneic marrow transplantation not possible or not desirable for any of the following reasons:

    • Over 60 years of age
    • No compatible donor identified
    • Estimated risk of graft-versus-host disease complications greater than risk of recurrence after autologous bone marrow transplantation
  • Patients with disease progression in a site of prior radiotherapy (4,000 cGy or more) are not eligible for total body irradiation (TBI) regimens

  • Hormone receptor status:

    • Not specified NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age

  • 4 and over (patients 60 years of age and over are not eligible for TBI)

Sex

  • Male or female

Menopausal status

  • Not specified

Performance status

  • Karnofsky 70-100%

Life expectancy

  • More than 2 months

Hematopoietic

  • WBC greater than 3,000/mm^3*
  • Polymorphonuclear leukocyte count greater than 1,500/mm^3*
  • Platelet count greater than 75,000/mm^3*
  • Marrow cellularity greater than 20%*
  • No marrow fibrosis* NOTE: *Before marrow storage

Hepatic

  • Bilirubin less than 3 times normal
  • Alkaline phosphatase less than 3 times normal
  • AST less than 3 times normal
  • Hepatitis status known

Renal

  • Creatinine clearance at least 50 mL/min (not required for patients with amyloidosis or multiple myeloma)

Cardiovascular

  • Ventricular ejection fraction at least 50% by radionuclide ventriculogram or echocardiogram
  • No myocardial infarction within the past 6 months
  • No congestive heart failure
  • No symptomatic angina
  • No life-threatening arrhythmia or hypertension

Pulmonary

  • DLCO or DLVA at least 50% of predicted (DLCO must be corrected for hemoglobin and/or alveolar ventilation)

Other

  • Not pregnant
  • HIV negative
  • Cytomegalovirus status known
  • No active bacterial, viral, or fungal infection
  • No active peptic ulcer disease
  • No uncontrolled diabetes mellitus
  • No serious organ dysfunction unless it is caused by the underlying disease
  • No other serious medical or psychiatric illness that would preclude giving informed consent or complying with study requirements

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • See Disease Characteristics
  • No prior cumulative nitrosourea dose greater than 600 mg/m^2
  • No prior cumulative bleomycin dose greater than 150 units/m^2
  • No prior cumulative doxorubicin dose greater than 450 mg/m^2
  • No prior cumulative daunorubicin dose greater than 600 mg/m^2
  • Patients with prior high-dose cyclophosphamide (greater than 150 mg/kg per cycle) and high-dose etoposide (greater than 2,400 mg/m^2 per cycle) are not eligible for the etoposide/cyclophosphamide/TBI conditioning regimen

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • More than 3 weeks since prior radiotherapy (before blood stem cell harvest)

  • Prior cumulative doses of radiotherapy must not exceed the following:

    • Spine/spinal cord: 4,000 cGy
    • Mediastinum: 4,000 cGy
    • Heart: 4,000 cGy
    • Kidney (whole): 1,500 cGy
    • Small bowel: 4,000 cGy
    • Brain: 4,000 cGy
    • Liver (whole): 2,000 cGy
    • Lungs (whole): 1,500 cGy
    • Bone: 5,000 cGy

Surgery

  • Not specified
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00060255


Locations
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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
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Study Chair: Philip L. McCarthy, MD Roswell Park Cancer Institute
More Information
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00060255    
Other Study ID Numbers: CDR0000301587
RPCI-DS-9115
First Posted: May 7, 2003    Key Record Dates
Last Update Posted: May 9, 2013
Last Verified: May 2013
Keywords provided by Roswell Park Cancer Institute:
stage IV breast cancer
male breast cancer
recurrent malignant testicular germ cell tumor
Waldenstrom macroglobulinemia
childhood acute lymphoblastic leukemia in remission
adult acute lymphoblastic leukemia in remission
recurrent adult acute myeloid leukemia
adult acute myeloid leukemia in remission
recurrent childhood acute myeloid leukemia
childhood acute myeloid leukemia in remission
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
recurrent adult diffuse large cell lymphoma
 recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult Hodgkin lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent childhood large cell lymphoma
recurrent childhood lymphoblastic lymphoma
recurrent childhood small noncleaved cell lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent/refractory childhood Hodgkin lymphoma
unspecified adult solid tumor, protocol specific
unspecified childhood solid tumor, protocol specific
Additional relevant MeSH terms:
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Lymphoma
Breast Neoplasms
Neoplasms
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases
 Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Cyclophosphamide
Melphalan
Busulfan
Thiotepa
Carmustine
Carboplatin
Etoposide
Immunosuppressive Agents