Recurrent Childhood Acute Lymphoblastic Leukemia Clinical Trial
Official title:
A Phase 1 Study of Temsirolimus in Combination With Intensive Re-induction Therapy for Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkin Lymphoma
This phase I trial studies the side effects and the best dose of temsirolimus when given together with dexamethasone, mitoxantrone hydrochloride, vincristine sulfate, and pegaspargase in treating young patients with relapsed acute lymphoblastic leukemia or non-Hodgkin lymphoma. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, mitoxantrone hydrochloride, vincristine sulfate, and pegaspargase work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving temsirolimus with combination chemotherapy may be and effective treatment for acute lymphoblastic leukemia or non-Hodgkin lymphoma.
PRIMARY OBJECTIVES:
I. To estimate the maximum-tolerated dose (MTD) and/or recommended phase 2 dose of
temsirolimus administered weekly for 2 doses in combination with intensive re-induction
chemotherapy in children with relapsed acute lymphoblastic leukemia (ALL) or non-Hodgkin
lymphoma (NHL).
II. To define and describe the toxicities of temsirolimus in combination with intensive
re-induction chemotherapy in children with relapsed ALL or NHL administered on this
schedule.
SECONDARY OBJECTIVES:
I. To compare minimal-residual disease (MRD) levels present at end of induction to
historical control in patients with relapsed ALL or NHL with bone marrow involvement of
disease.
II. To determine the complete remission (CR) rate in patients with ALL or NHL who receive
this regimen.
III. To evaluate responsiveness of patient ALL cells to mammalian target of rapamycin (mTOR)
inhibition using in vitro and in vivo pharmacodynamic assessment of the response of ALL
blasts to temsirolimus.
OUTLINE: This is a dose-escalation study of temsirolimus.
Patients receive dexamethasone orally (PO) or intravenously (IV) on days 1-5 and 15-19;
mitoxantrone hydrochloride IV over 30 minutes on days 1-2; temsirolimus IV over 30 minutes
on days 1 and 8; vincristine sulfate IV on days 1, 8, 15, and 22; and pegaspargase IV over 1
hour on days 3 and 17. Some patients may also receive methotrexate intrathecally (IT) up to
72 hours prior to or on day 1 and on day 8.
After completion of study therapy, patients are followed up for 30 days.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01527045 -
Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies
|
Phase 2 | |
| Completed |
NCT00897325 -
Collecting and Storing Samples of Bone Marrow and Blood From Patients With Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma
|
||
| Completed |
NCT01371656 -
Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation
|
Phase 3 | |
| Completed |
NCT01427881 -
Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies
|
Phase 2 | |
| Completed |
NCT01093586 -
Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
|
Phase 2 | |
| Completed |
NCT00093821 -
Tanespimycin in Treating Young Patients With Recurrent or Refractory Leukemia or Solid Tumors
|
Phase 1 | |
| Completed |
NCT00078858 -
Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant
|
Phase 1/Phase 2 | |
| Completed |
NCT00053963 -
FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia
|
Phase 1 | |
| Completed |
NCT00052520 -
Biological Therapy in Treating Patients With Advanced Myelodysplastic Syndrome, Acute or Chronic Myeloid Leukemia, or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation
|
Phase 1/Phase 2 | |
| Completed |
NCT00031655 -
Reduced Intensity Donor Stem Cell Transplant in Treating Patients With High Risk Acute Lymphocytic Leukemia in Complete Remission
|
Phase 2 | |
| Completed |
NCT00003528 -
Raltitrexed in Treating Children With Refractory Acute Leukemia
|
Phase 1 | |
| Completed |
NCT00022737 -
Combination Chemotherapy With or Without Peripheral Stem Cell Transplant in Treating Children With Acute Lymphoblastic Leukemia
|
Phase 3 | |
| Recruiting |
NCT03241940 -
Phase I Dose Escalation Study of CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies
|
Phase 1 | |
| Completed |
NCT01817075 -
Chlorhexidine Gluconate Cleansing in Preventing Central Line Associated Bloodstream Infection and Acquisition of Multi-drug Resistant Organisms in Younger Patients With Cancer or Undergoing Donor Stem Cell Transplant
|
Phase 3 | |
| Completed |
NCT02847130 -
Identifying, Understanding, and Overcoming Barriers to the Use of Clinical Practice Guidelines in Pediatric Oncology
|
||
| Terminated |
NCT00101205 -
Oxaliplatin, Ifosfamide and Etoposide in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma
|
Phase 1 | |
| Completed |
NCT00105001 -
Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer
|
Phase 2 | |
| Completed |
NCT00898404 -
Response or Resistance to Chemotherapy in Young Patients With Acute Lymphoblastic Leukemia Treated With Methotrexate
|
N/A | |
| Terminated |
NCT00058461 -
Combination Chemotherapy and Rituximab in Treating Young Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or Acute Lymphoblastic Leukemia
|
Phase 2 | |
| Completed |
NCT00040846 -
Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies
|
Phase 2 |