Lymphoma Clinical Trial
Official title:
Phase I Trial of High Dose Chemotherapy Using Amifostine for In-Vivo Protection of GM-CSF Primed Progenitor Cells
RATIONALE: Drugs used in chemotherapy use different ways to stop tumors from dividing so
they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal
cells from the side effects of chemotherapy.
PURPOSE: Phase I trial to study the effectiveness of amifostine plus combination
chemotherapy in treating patients with advanced cancer.
OBJECTIVES: I. Determine the effects of priming on the granulocyte and thrombocyte nadirs
produced by high dose cyclophosphamide and carboplatin in patients with advanced
malignancies. II. Determine the effects of amifostine on the granulocyte and thrombocyte
nadirs produced by this same regimen when administered with sargramostim primed progenitor
cells. III. Determine the maximum tolerated dose of cyclophosphamide and carboplatin that
can be administered with sargramostim primed progenitor cells.
OUTLINE: This is a dose escalation study. Patients receive intravenous amifostine over 10
minutes on day 0, followed by intravenous cyclophosphamide and carboplatin consecutively
over 5-15 minutes. Sargramostim is administered subcutaneously on days -7 to -2 and again
beginning on day 1 until absolute neutrophil count is appropriate. Course is repeated every
28 days until disease progression or unacceptable toxic effects are observed. Nonresponding
patients discontinue treatment after 2 courses. Patients are treated for a maximum of 6
courses. Groups of 3-6 patients receive escalating doses of cyclophosphamide and carboplatin
until the maximum tolerated dose (MTD) is determined. If dose limiting toxicity (DLT) occurs
in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower
dose is declared the MTD.
PROJECTED ACCRUAL: Approximately 24-30 patients will be accrued for this study within 1
year.
;
Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05540340 -
A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant
|
Phase 1 | |
| Completed |
NCT01947140 -
Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies
|
Phase 1/Phase 2 | |
| Completed |
NCT00001512 -
Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines
|
Phase 1 | |
| Recruiting |
NCT05618041 -
The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies
|
N/A | |
| Completed |
NCT01410630 -
FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma
|
||
| Active, not recruiting |
NCT04270266 -
Mind-Body Medicine for the Improvement of Quality of Life in Adolescents and Young Adults Coping With Lymphoma
|
N/A | |
| Terminated |
NCT00801931 -
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders
|
Phase 1/Phase 2 | |
| Completed |
NCT01949883 -
A Phase 1 Study Evaluating CPI-0610 in Patients With Progressive Lymphoma
|
Phase 1 | |
| Completed |
NCT01682226 -
Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies
|
Phase 2 | |
| Completed |
NCT00003270 -
Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
|
Phase 2 | |
| Recruiting |
NCT04904588 -
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
|
Phase 2 | |
| Recruiting |
NCT05019976 -
Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma
|
N/A | |
| Completed |
NCT04434937 -
Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)
|
Phase 2 | |
| Completed |
NCT01855750 -
A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
|
Phase 3 | |
| Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Terminated |
NCT00775268 -
18F- Fluorothymidine to Evaluate Treatment Response in Lymphoma
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04188678 -
Resiliency in Older Adults Undergoing Bone Marrow Transplant
|
N/A | |
| Terminated |
NCT00014560 -
Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
| Recruiting |
NCT04977024 -
SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03936465 -
Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitors BMS-986158 and BMS-986378 in Pediatric Cancer
|
Phase 1 |