- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00060255
High-Dose Chemotherapy, Total-Body Irradiation, and Autologous Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Hematologic Cancer or Solid Tumors
Autologous Blood and Marrow Transplantation for Hematologic Malignancy and Selected Solid Tumors
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.
Study Overview
Status
Conditions
Intervention / Treatment
- Procedure: peripheral blood stem cell transplantation
- 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
- Radiation: radiation therapy
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Morbidity
Time Frame: +day 100
|
+day 100
|
Mortality
Time Frame: +day 100, +day 360
|
+day 100, +day 360
|
Overall outcome
Time Frame: every 6 months until death
|
every 6 months until death
|
Response rate
Time Frame: +day 100, +day 360
|
+day 100, +day 360
|
Toxicity
Time Frame: +day100, +day 360
|
+day100, +day 360
|
Disease-free survival
Time Frame: up to 15years
|
up to 15years
|
Overall survival
Time Frame: every 6 months until death
|
every 6 months until death
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Philip L. McCarthy, MD, Roswell Park Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- unspecified childhood solid tumor, protocol specific
- stage IV breast cancer
- stage IIIA breast cancer
- recurrent breast cancer
- stage IIIB breast cancer
- unspecified adult solid tumor, protocol specific
- male breast cancer
- stage IIIC breast cancer
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult Burkitt lymphoma
- recurrent childhood small noncleaved cell lymphoma
- recurrent childhood large cell lymphoma
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities
- 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)
- childhood acute lymphoblastic leukemia in remission
- childhood acute myeloid leukemia in remission
- chronic phase chronic myelogenous leukemia
- childhood chronic myelogenous leukemia
- primary systemic amyloidosis
- recurrent adult acute myeloid leukemia
- atypical chronic myeloid leukemia
- adult acute myeloid leukemia in remission
- recurrent adult Hodgkin lymphoma
- recurrent/refractory childhood Hodgkin lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- blastic phase chronic myelogenous leukemia
- Waldenstrom macroglobulinemia
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- 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
- recurrent mantle cell lymphoma
- refractory chronic lymphocytic leukemia
- refractory multiple myeloma
- accelerated phase chronic myelogenous leukemia
- adult acute lymphoblastic leukemia in remission
- recurrent childhood acute myeloid leukemia
- recurrent childhood lymphoblastic lymphoma
- recurrent malignant testicular germ cell tumor
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Hematologic Diseases
- Breast Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms
- Lymphoma
- Neoplasms, Germ Cell and Embryonal
- Breast Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Leukemia
- Plasmacytoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Cyclophosphamide
- Carboplatin
- Etoposide
- Melphalan
- Thiotepa
- Busulfan
- Carmustine
Other Study ID Numbers
- CDR0000301587
- RPCI-DS-9115
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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