Trials / Completed
CompletedNCT00536601
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 174 (actual)
- Sponsor
- Roswell Park Cancer Institute · Academic / Other
- Sex
- All
- Age
- 4 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | etoposide | Given IV |
| DRUG | cyclophosphamide | Given IV |
| DRUG | carmustine | Given IV |
| DRUG | melphalan | Given IV |
| DRUG | busulfan | Given IV |
| DRUG | carboplatin | Given IV |
| DRUG | thiotepa | Given IV |
| RADIATION | total-body irradiation | Undergo TBI |
| PROCEDURE | autologous hematopoietic stem cell transplantation | Undergo ASCT |
| PROCEDURE | autologous-autologous tandem hematopoietic stem cell transplantation | Undergo tandem ASCT |
Timeline
- Start date
- 2006-06-29
- Primary completion
- 2018-07-09
- Completion
- 2018-07-09
- First posted
- 2007-09-28
- Last updated
- 2021-04-22
- Results posted
- 2021-04-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00536601. Inclusion in this directory is not an endorsement.