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NCT00536601 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
COMPLETED
Registry last update
2021-04-22

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors)

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outcome · POSTED

Regimen-related Toxicity Grade 2-4 in Any Organ (Measured by Bearman Score, Values Range From 0 (None) to 4 (Fatal))

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outcome · POSTED

Response Rate (Complete Remission)

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outcome · POSTED

Overall Survival, Presented as the Estimate at 10-yrs (Median Follow-up Time in Survivors)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
4 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: etoposide
    2. Drug: cyclophosphamide
    3. Drug: carmustine
    4. Procedure: autologous hematopoietic stem cell transplantation
    label
    Regimen CBV (patients with HL or NHL)
    type
    EXPERIMENTAL
  2. description
    Patients receive 200 or 120 mg/m\^2 of melphalan IV over 30 minutes on day -2. Patients undergo ASCT on day 0.
    intervention Names
    1. Drug: melphalan
    2. Procedure: autologous hematopoietic stem cell transplantation
    label
    Regimen M200/M120 (patients with MM or amyloidosis)
    type
    EXPERIMENTAL
  3. description
    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.
    intervention Names
    1. Drug: cyclophosphamide
    2. Drug: busulfan
    3. Procedure: autologous hematopoietic stem cell transplantation
    label
    Regimen BuC2iv (patients with ALL, AML, HL, or NHL)
    type
    EXPERIMENTAL
  4. description
    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.
    intervention Names
    1. Drug: cyclophosphamide
    2. Radiation: total-body irradiation
    3. Procedure: autologous hematopoietic stem cell transplantation
    label
    Regimen CT6 (patients with ALL)
    type
    EXPERIMENTAL
  5. description
    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.
    intervention Names
    1. Drug: cyclophosphamide
    2. Drug: carboplatin
    3. Drug: thiotepa
    4. Procedure: autologous hematopoietic stem cell transplantation
    label
    Regimen CTtCp (patients with other solid tumors)
    type
    EXPERIMENTAL
  6. description
    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.
    intervention Names
    1. Drug: etoposide
    2. Drug: carboplatin
    3. Procedure: autologous-autologous tandem hematopoietic stem cell transplantation
    label
    Regimen VCp (patients with testicular cancer)
    type
    EXPERIMENTAL
  7. description
    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.
    intervention Names
    1. Drug: etoposide
    2. Drug: cyclophosphamide
    3. Drug: melphalan
    4. Drug: carboplatin
    5. Drug: thiotepa
    6. Procedure: autologous-autologous tandem hematopoietic stem cell transplantation
    label
    Regimen TtC1500/ECpM (patients with NBL or SRBCT)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Regimen CBV (patients with HL or NHL)
    2. Regimen TtC1500/ECpM (patients with NBL or SRBCT)
    3. Regimen VCp (patients with testicular cancer)
    description
    Given IV
    name
    etoposide
    other Names
    1. EPEG
    2. VP-16
    3. VP-16-213
    type
    DRUG
  2. arm Group Labels
    1. Regimen BuC2iv (patients with ALL, AML, HL, or NHL)
    2. Regimen CBV (patients with HL or NHL)
    3. Regimen CT6 (patients with ALL)
    4. Regimen CTtCp (patients with other solid tumors)
    5. Regimen TtC1500/ECpM (patients with NBL or SRBCT)
    description
    Given IV
    name
    cyclophosphamide
    other Names
    1. CPM
    2. CTX
    3. Cytoxan
    4. Endoxan
    5. Endoxana
    type
    DRUG
  3. arm Group Labels
    1. Regimen CBV (patients with HL or NHL)
    description
    Given IV
    name
    carmustine
    other Names
    1. BCNU
    2. BiCNU
    3. bis-chloronitrosourea
    type
    DRUG
  4. arm Group Labels
    1. Regimen M200/M120 (patients with MM or amyloidosis)
    2. Regimen TtC1500/ECpM (patients with NBL or SRBCT)
    description
    Given IV
    name
    melphalan
    other Names
    1. Alkeran
    2. CB-3025
    3. L-PAM
    4. L-phenylalanine mustard
    5. L-Sarcolysin
    type
    DRUG
  5. arm Group Labels
    1. Regimen BuC2iv (patients with ALL, AML, HL, or NHL)
    description
    Given IV
    name
    busulfan
    other Names
    1. BSF
    2. BU
    3. Misulfan
    4. Mitosan
    5. Myeloleukon
    type
    DRUG
  6. arm Group Labels
    1. Regimen CTtCp (patients with other solid tumors)
    2. Regimen TtC1500/ECpM (patients with NBL or SRBCT)
    3. Regimen VCp (patients with testicular cancer)
    description
    Given IV
    name
    carboplatin
    other Names
    1. Carboplat
    2. CBDCA
    3. JM-8
    4. Paraplat
    5. Paraplatin
    type
    DRUG
  7. arm Group Labels
    1. Regimen CTtCp (patients with other solid tumors)
    2. Regimen TtC1500/ECpM (patients with NBL or SRBCT)
    description
    Given IV
    name
    thiotepa
    other Names
    1. Oncotiotepa
    2. STEPA
    3. TESPA
    4. Tespamin
    5. TSPA
    type
    DRUG
  8. arm Group Labels
    1. Regimen CT6 (patients with ALL)
    description
    Undergo TBI
    name
    total-body irradiation
    other Names
    1. TBI
    type
    RADIATION
  9. arm Group Labels
    1. Regimen BuC2iv (patients with ALL, AML, HL, or NHL)
    2. Regimen CBV (patients with HL or NHL)
    3. Regimen CT6 (patients with ALL)
    4. Regimen CTtCp (patients with other solid tumors)
    5. Regimen M200/M120 (patients with MM or amyloidosis)
    description
    Undergo ASCT
    name
    autologous hematopoietic stem cell transplantation
    type
    PROCEDURE
  10. arm Group Labels
    1. Regimen TtC1500/ECpM (patients with NBL or SRBCT)
    2. Regimen VCp (patients with testicular cancer)
    description
    Undergo tandem ASCT
    name
    autologous-autologous tandem hematopoietic stem cell transplantation
    type
    PROCEDURE
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
174
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Assessed using the product-limit based Kaplan Meier method. Additionally, a 95% confidence interval of the distribution will be computed.
    measure
    Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors)
    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
secondary Outcomes
  1. description
    Toxicities will be reported using descriptive statistics.
    measure
    Regimen-related Toxicity Grade 2-4 in Any Organ (Measured by Bearman Score, Values Range From 0 (None) to 4 (Fatal))
    time Frame
    Up to 100 days after transplantation
  2. description
    Response rates will be reported using descriptive statistics.
    measure
    Response Rate (Complete Remission)
    time Frame
    At 100 days
  3. description
    Assessed using the product-limit based Kaplan Meier method.
    measure
    Overall Survival, Presented as the Estimate at 10-yrs (Median Follow-up Time in Survivors)
    time Frame
    Patients are followed up to maximum of 12 years
Full study description
brief Summary
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.
detailed Description
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.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice