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High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00536601
First received: September 27, 2007
Last updated: March 25, 2014
Last verified: March 2014

September 27, 2007
March 25, 2014
June 2006
July 2011   (final data collection date for primary outcome measure)
Progression-free survival distribution of patients with HL, NHL, and MM for each disease-specific high-dose therapy regimen [ Time Frame: From the date of transplantation to the date of first observed disease progression or death due to any cause, assessed up to 12 years ] [ Designated as safety issue: No ]
Assessed using the product-limit based Kaplan Meier method. Additionally, a 95% confidence interval of the distribution will be computed based on Greenwood's formula for the variance of the survival function.
  • Progression-free survival
  • Efficacy
  • Toxicity
  • Response rates
  • Overall survival
  • Impact of prognostic significance of disease-specific standard-, intermediate-, and high-risk groups on prediction of relapse risk post-transplantation
Complete list of historical versions of study NCT00536601 on ClinicalTrials.gov Archive Site
  • Progression-free survival distribution of patients with amyloidosis, acute leukemia, and selected solid tumors for each disease-specific high-dose therapy regimen [ Time Frame: From the date of transplantation to the date of first observed disease progression or death due to any cause, assessed up to 12 years ] [ Designated as safety issue: No ]
    Assessed using the product-limit based Kaplan Meier method. Additionally, a 95% confidence interval of the distribution will be computed based on Greenwood's formula for the variance of the survival function.
  • Regimen-related toxicity [ Time Frame: At 100 days ] [ Designated as safety issue: Yes ]
    Toxicities will be reported using descriptive statistics.
  • Response rate [ Time Frame: At 100 days ] [ Designated as safety issue: No ]
    Response rates will be reported using descriptive statistics.
  • Overall survival [ Time Frame: Up to 12 years ] [ Designated as safety issue: No ]
    Assessed using the product-limit based Kaplan Meier method.
Not Provided
Not Provided
Not Provided
 
High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors
Autologous Blood and Marrow Transplantation for Hematologic Malignancies and Selected Solid Tumors

This pilot trial studies different high-dose chemotherapy regimens with or without total-body irradiation (TBI) to compare how well they work when given before autologous stem cell transplant (ASCT) in treating patients with hematologic cancer or solid tumors. Giving high-dose chemotherapy with or without TBI before ASCT stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood or bone marrow and stored. More chemotherapy may be given to prepare for the stem cell transplant. The stem cells are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy.

PRIMARY OBJECTIVES:

I. Estimate the progression free survival (PFS) distribution for Hodgkin lymphoma (HL), non-Hodgkin lymphoma (NHL) and multiple myeloma (MM) for each disease-specific high dose therapy regimen.

SECONDARY OBJECTIVES:

I. Estimate the PFS distribution for amyloidosis, acute leukemia and selected solid tumors for each disease-specific high dose therapy regimen.

II. Explore the role of risk factors in the outcome of all treated patients. III. Examine the high dose therapy regimen-related toxicity (RRT) and overall survival after bone marrow transplant (BMT).

OUTLINE:

Patients are assigned to conditioning regimens based on disease, age, and co-morbidities.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Adult Acute Lymphoblastic Leukemia in Remission
  • Adult Acute Myeloid Leukemia in Remission
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Adult Nasal Type Extranodal NK/T-cell Lymphoma
  • Childhood Acute Lymphoblastic Leukemia in Remission
  • Childhood Acute Myeloid Leukemia in Remission
  • Childhood Burkitt Lymphoma
  • Childhood Diffuse Large Cell Lymphoma
  • Childhood Immunoblastic Large Cell Lymphoma
  • Childhood Nasal Type Extranodal NK/T-cell Lymphoma
  • Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET)
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Hepatosplenic T-cell Lymphoma
  • Intraocular Lymphoma
  • Nodal Marginal Zone B-cell Lymphoma
  • Peripheral T-cell Lymphoma
  • Plasma Cell Neoplasm
  • Primary Systemic Amyloidosis
  • Recurrent Adult Acute Lymphoblastic Leukemia
  • Recurrent Adult Acute Myeloid Leukemia
  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Diffuse Mixed Cell Lymphoma
  • Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
  • Recurrent Adult Grade III Lymphomatoid Granulomatosis
  • Recurrent Adult Hodgkin Lymphoma
  • Recurrent Adult Immunoblastic Large Cell Lymphoma
  • Recurrent Adult Lymphoblastic Lymphoma
  • Recurrent Childhood Acute Lymphoblastic Leukemia
  • Recurrent Childhood Acute Myeloid Leukemia
  • Recurrent Childhood Anaplastic Large Cell Lymphoma
  • Recurrent Childhood Grade III Lymphomatoid Granulomatosis
  • Recurrent Childhood Large Cell Lymphoma
  • Recurrent Childhood Lymphoblastic Lymphoma
  • Recurrent Childhood Small Noncleaved Cell Lymphoma
  • Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
  • Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Malignant Testicular Germ Cell Tumor
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Neuroblastoma
  • Recurrent Small Lymphocytic Lymphoma
  • Recurrent/Refractory Childhood Hodgkin Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Multiple Myeloma
  • Regional Neuroblastoma
  • Splenic Marginal Zone Lymphoma
  • Testicular Lymphoma
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • Waldenström Macroglobulinemia
  • Drug: etoposide
    Given IV
    Other Names:
    • EPEG
    • VP-16
    • VP-16-213
  • Drug: cyclophosphamide
    Given IV
    Other Names:
    • CPM
    • CTX
    • Cytoxan
    • Endoxan
    • Endoxana
  • Drug: carmustine
    Given IV
    Other Names:
    • BCNU
    • BiCNU
    • bis-chloronitrosourea
  • Drug: melphalan
    Given IV
    Other Names:
    • Alkeran
    • CB-3025
    • L-PAM
    • L-phenylalanine mustard
    • L-Sarcolysin
  • Drug: busulfan
    Given IV
    Other Names:
    • BSF
    • BU
    • Misulfan
    • Mitosan
    • Myeloleukon
  • Drug: carboplatin
    Given IV
    Other Names:
    • Carboplat
    • CBDCA
    • JM-8
    • Paraplat
    • Paraplatin
  • Drug: thiotepa
    Given IV
    Other Names:
    • Oncotiotepa
    • STEPA
    • TESPA
    • Tespamin
    • TSPA
  • Radiation: total-body irradiation
    Undergo TBI
    Other Name: TBI
  • Procedure: autologous hematopoietic stem cell transplantation
    Undergo ASCT
  • Procedure: autologous-autologous tandem hematopoietic stem cell transplantation
    Undergo tandem ASCT
  • Experimental: Regimen CBV (patients with HL or NHL)
    Patients receive etoposide intravenously (IV) continuously over 34 hours on day -8, cyclophosphamide IV over 2 hours on days -7 to -4, and carmustine IV over 2 hours on day -3. Patients undergo ASCT on day 0.
    Interventions:
    • Drug: etoposide
    • Drug: cyclophosphamide
    • Drug: carmustine
    • Procedure: autologous hematopoietic stem cell transplantation
  • Experimental: Regimen M200/M120 (patients with MM or amyloidosis)
    Patients receive 200 or 120 mg/m^2 of melphalan IV over 30 minutes on day -2. Patients undergo ASCT on day 0.
    Interventions:
    • Drug: melphalan
    • Procedure: autologous hematopoietic stem cell transplantation
  • Experimental: Regimen BuC2iv (patients with ALL, AML, HL, or NHL)
    Patients receive busulfan IV over 2 hours then every 6 hours on days -7 to -4 for 16 total doses and cyclophosphamide IV over 2 hours on days -3 and -2. Patients undergo ASCT on day 0.
    Interventions:
    • Drug: cyclophosphamide
    • Drug: busulfan
    • Procedure: autologous hematopoietic stem cell transplantation
  • Experimental: Regimen CT6 (patients with ALL)
    Patients receive cyclophosphamide IV over 2 hours on days -5 to -4. Patients then undergo TBI twice daily on days -3 to -1. Patients undergo ASCT on day 0.
    Interventions:
    • Drug: cyclophosphamide
    • Radiation: total-body irradiation
    • Procedure: autologous hematopoietic stem cell transplantation
  • Experimental: Regimen CTtCp (patients with other solid tumors)
    Patients receive cyclophosphamide IV continuously, carboplatin IV continuously, and thiotepa IV continuously over 24 hours on days -7 to -4. Patients undergo ASCT on day 0.
    Interventions:
    • Drug: cyclophosphamide
    • Drug: carboplatin
    • Drug: thiotepa
    • Procedure: autologous hematopoietic stem cell transplantation
  • Experimental: Regimen VCp (patients with testicular cancer)
    Patients receive etoposide IV over 2-3 hours and carboplatin IV over 30 minutes on days -6 to -4. Patients undergo ASCT on day 0. At least 4 weeks after the first transplant, patients receive etoposide IV over 2-3 hours and carboplatin IV over 30 minutes on days -6 to -4. Patients then undergo a second ASCT on day 0.
    Interventions:
    • Drug: etoposide
    • Drug: carboplatin
    • Procedure: autologous-autologous tandem hematopoietic stem cell transplantation
  • Experimental: Regimen TtC1500/ECpM (patients with NBL or SRBCT)
    Patients receive thiotepa IV over 2 hours on days -7 to -5 and cyclophosphamide IV over 2 hours on days -5 to -2. Patients undergo ASCT on day 0. At least 4 weeks after the first transplant, patients receive carboplatin IV continuously over 24 hours on days -7 to -4, etoposide IV continuously over 24 hours on days -7 to -4, and melphalan IV over 30 minutes on days -7 to -5. Patients undergo a second ASCT on day 0.
    Interventions:
    • Drug: etoposide
    • Drug: cyclophosphamide
    • Drug: melphalan
    • Drug: carboplatin
    • Drug: thiotepa
    • Procedure: autologous-autologous tandem hematopoietic stem cell transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
174
Not Provided
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed diagnosis of malignant hematologic disorders, amyloidosis or solid tumor malignancy
  • Recurrent or refractory disease or disease at high risk for recurrence
  • Hodgkin Disease (HL): Relapsed or refractory disease after chemotherapy with a minimum of one standard regimen
  • Non-Hodgkin Lymphoma (NHL): (Low, Intermediate or High Grade) Relapsed or refractory disease after chemotherapy with at least one standard regimen or first complete remission (CR) lymphoblastic or small, non-cleaved cell lymphoma at high risk of relapse by high International Prognostic Index (IPI) Score
  • Acute Myeloid Leukemia (AML): Low or High Risk disease in first or second CR or greater in patients in whom the risks of an allogeneic transplant outweigh the benefits
  • Acute Lymphoblastic Leukemia (ALL): Low or high risk disease in first or second CR in whom the risks of an allogeneic transplant outweigh the benefits
  • Multiple Myeloma (MM): Low or high risk in first or greater response (stable disease or better) or for responding patients at first progression
  • Other Malignant Lymphoproliferative Disorders: (chronic lymphocytic lymphoma [CLL], Waldenstroms macroglobulinemia, relapsed or refractory disease after first-line chemotherapy
  • Amyloidosis: primary or previously treated
  • Solid Tumors: Testicular cancer patients who have relapsed disease or primary progressive disease which is responding to salvage therapy; relapsed or advanced-stage newly diagnosed neuroblastoma (NBL) or small round blue cell tumors (SRBCT) in patients 30 years of age; other patients with solid tumors who have recurred following conventional treatment or are at high risk for relapse, and demonstrate chemosensitivity
  • Patients with malignancies who would be treated with an autologous stem cell transplant but have a syngeneic donor; a syngeneic donor would be considered to have the same risk as an autologous stem cell transplant patient
  • Performance status 0-2 (Karnofsky performance status [KPS] >= 70%); patients with amyloidosis or MM with decreased KPS due to disease are eligible
  • Life expectancy > 2 months
  • Pulmonary function tests; diffusing capacity of the lung for carbon monoxide (DLCO) or diffusing volume of the alveolar volume (DLVA) >= 50% predicted; DLCO to be corrected for hemoglobin and/or alveolar ventilation
  • Cardiac ventricular ejection fraction >= 50% by radionuclide ventriculogram or echocardiogram
  • Bilirubin < 3 x normal
  • Alkaline phosphatase, serum glutamic oxaloacetic transaminase (SGOT) < 3 x normal
  • Calculated creatinine clearance < 40 cc/min by the modified Cockcroft-Gault formula for adults or the Schwartz formula for pediatrics
  • Glomerular filtration rate by renal scan for neuroblastoma patients, to determine dosing parameters
  • Positive cytomegalovirus (CMV) immunoglobulin M (IgM) and/or positive hepatitis serologies demonstrating infection will require an Infectious Disease consult and subsequent clearance
  • Any active infection will require an Infectious Disease consult and subsequent clearance
  • Peripheral Blood Counts of polymorphonuclear neutrophil (PMN) > 1500/uL
  • Platelet (Plt) > 75,000/uL
  • Prior to stem cell storage:

    • No radiation within three weeks before stem cell harvest
    • Bone marrow may be used in conjunction with blood progenitor cells
  • Hematologic Malignancy patients with human immunodeficiency virus (HIV) positivity but on appropriate anti-retroviral therapy may go autotransplant with the following laboratory tests; (CD4+ cell count > 75 cells per microliter and HIV copy number < 100,000 per microliter and with Infectious Disease clearance
  • Acute Leukemia, HL, NHL, MM and Solid Tumor patients must have received 2 cycles of chemotherapy followed by disease-specific restaging prior to mobilization and collection of stem cells; small round blue cell tumor patients must have received either standard therapy or surgical intervention; the disease status and response to therapy must be known prior to transplant to establish the disease status at transplant; amyloidosis patients may proceed to BMT without receiving chemotherapy
  • No serious organ dysfunction unless it is caused by the underlying disease, exclusion criteria include the following:

    • Uncontrolled or severe cardiovascular disease, including recent (< 6 months) myocardial infarction, congestive heart failure, symptomatic angina, life-threatening arrhythmia or hypertension
    • Active bacterial, viral, or fungal infection
    • Active peptic ulcer disease
    • Uncontrolled diabetes mellitus
  • No serious medical or psychiatric illness
  • Not pregnant
  • No psychiatric conditions which would prevent delivery of care; psychology clearance is necessary
  • Allogeneic BMT not possible, or not desirable

    • Age > 65 years
    • No compatible donor identified
    • Estimated risk of graft vs. host disease complications greater than risk of recurrence after autologous BMT
  • Adequate bone marrow or blood stem cell dose obtained:

    • For blood stem cells: total CD 34+ >= 2 x 10^6/kg or if unable to collect this dose, a total nucleated cell bone marrow dose of >= l x 10^8/kg
Both
4 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00536601
I 72806, NCI-2011-00131, I 72806, P30CA016056
Yes
Roswell Park Cancer Institute
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Philip McCarthy Roswell Park Cancer Institute
Roswell Park Cancer Institute
March 2014

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