High-Dose Chemotherapy, Total-Body Irradiation, and Autol... | NCT00060255 | Trialant
NCT00060255
Sponsor
Roswell Park Cancer Institute
Status
Completed
Last Update Posted
May 9, 2013Estimated
Enrollment
451Actual
Phase
Phase 2
Conditions
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
Interventions
busulfan
carboplatin
carmustine
cyclophosphamide
etoposide
melphalan
thiotepa
autologous bone marrow transplantation
bone marrow ablation with stem cell support
peripheral blood stem cell transplantation
radiation therapy
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00060255
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000301587
Secondary IDs
ID
Type
Description
Link
RPCI-DS-9115
Brief Title
High-Dose Chemotherapy, Total-Body Irradiation, and Autologous Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Hematologic Cancer or Solid Tumors
Official Title
Autologous Blood and Marrow Transplantation for Hematologic Malignancy and Selected Solid Tumors
Acronym
Not provided
Organization
Roswell Park Cancer InstituteOTHER
Status Module
Record Verification Date
May 2013
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 1991
Primary Completion Date
Aug 2006Actual
Completion Date
Feb 2013Actual
First Submitted Date
May 6, 2003
First Submission Date that Met QC Criteria
May 6, 2003
First Posted Date
May 7, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 7, 2013
Last Update Posted Date
May 9, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Roswell Park Cancer InstituteOTHER
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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 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.
Conditions Module
Conditions
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
Keywords
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
451Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
busulfan
Drug
iv
carboplatin
Drug
iv
carmustine
Drug
iv
cyclophosphamide
Drug
iv
etoposide
Drug
iv
melphalan
Drug
oral
thiotepa
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Morbidity
+day 100
Mortality
+day 100, +day 360
Overall outcome
every 6 months until death
Response rate
+day 100, +day 360
Toxicity
+day100, +day 360
Disease-free survival
up to 15years
Overall survival
every 6 months until death
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility 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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
4 Years
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Philip L. McCarthy, MD
Roswell Park Cancer Institute
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Roswell Park Cancer Institute
Buffalo
New York
14263-0001
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
recurrent breast cancer
primary systemic amyloidosis
refractory multiple myeloma
childhood chronic myelogenous leukemia
atypical chronic myeloid leukemia
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with t(15;17)(q22;q12)