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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Novartis |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00968253 |
Purpose
The goal of Phase I of this clinical research study is to find the highest tolerable dose of RAD001 (everolimus) when given in combination with the standard chemotherapy regimens to patients with ALL.
The goal of Phase II of this study is to learn if the drug combinations can help to control ALL. The safety of these drug combinations will be also studied in both phases.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Acute Lymphocytic Leukemia |
Drug: Everolimus (RAD001) Drug: Cyclophosphamide Drug: Vincristine Drug: Doxorubicin Drug: Dexamethasone Drug: Mesna Drug: Methotrexate Drug: Ara-C (Cytarabine) Drug: Solu-Medrol Drug: G-CSF |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I/II Study of Hyper-CVAD Plus RAD001 (Everolimus) for Patients With Relapsed or Refractory Acute Lymphocytic Leukemia (ALL) |
| Estimated Enrollment: | 42 |
| Study Start Date: | November 2009 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Everolimus + Hyper-CVAD
First chemotherapy combination is Hyper-CVAD = Cyclophosphamide, Vincristine, Adriamycin (doxorubicin), and Dexamethasone
|
Drug: Everolimus (RAD001)
Beginning dose of 5 mg tablets every other day by mouth followed by a big glass of water. First dose will occur 1 day before receiving chemotherapy.
Other Name: Afinitor
Drug: Cyclophosphamide
300 mg/m^2 IV over 3 hours every 12 hours x 6 doses on Days 1, 2, 3 (total dose 1800 mg/m2).
Other Names:
Drug: Vincristine
2 mg IV on Day 4 and Day 11 ± 2 days.
Drug: Doxorubicin
50 mg/m^2 IV over 24 hours via central venous catheter on day 4, after last dose of Cyclophosphamide given.
Other Names:
Drug: Dexamethasone
40 mg IV or orally daily days 1-4 ± 2 days and days 11-14 ± 2 days.
Other Name: Decadron
Drug: Mesna
600 mg/m^2 IV continuous infusion daily for 24 hours days 1-3.
Other Name: Mesnex
Drug: G-CSF
10 mcg/kg/day (rounded) within 72 ± 48 hours after completion of chemotherapy until neutrophil recovery 1 x 109/L or higher. Pegfilgrastim (given at 6 mg subcutaneous for one dose approximately 24 hours after completion of the chemotherapy) may be substituted for G-CSF.
Other Names:
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Experimental: Everolimus + Methotrexate and Ara-C
Second chemotherapy combination is Methotrexate and Ara-C (cytarabine).
|
Drug: Everolimus (RAD001)
Beginning dose of 5 mg tablets every other day by mouth followed by a big glass of water. First dose will occur 1 day before receiving chemotherapy.
Other Name: Afinitor
Drug: Methotrexate
200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 IV over 22 hours day 1.
Drug: Ara-C (Cytarabine)
3 gm/m^2 IV over 2 hours every 12 hours for 4 doses on days 2, 3.
Other Names:
Drug: Solu-Medrol
50 mg IV over 2 hours approximately every 12 hours for 6 doses days 1-3.
Other Names:
Drug: G-CSF
10 mcg/kg/day (rounded) within 72 ± 48 hours after completion of chemotherapy until neutrophil recovery 1 x 109/L or higher. Pegfilgrastim (given at 6 mg subcutaneous for one dose approximately 24 hours after completion of the chemotherapy) may be substituted for G-CSF.
Other Names:
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 10 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Marina Konopleva, MD, PHD | 713-794-1628 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Marina Konopleva, MD, PHD | |
| Study Chair: | Marina Konopleva, MD, PHD | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00968253 History of Changes |
| Other Study ID Numbers: | 2009-0100 |
| Study First Received: | August 27, 2009 |
| Last Updated: | May 23, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Acute Lymphocytic Leukemia ALL Hyper-CVAD RAD001 Everolimus 6-mercaptopurine Citrovorum Cyclophosphamide Cytarabine |
Dexamethasone Doxorubicin G-CSF Methotrexate MESNA Pegfilgrastim Prednisone Solumedrol Vincristine Sulfate |
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Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Mesna Methylprednisolone Methylprednisolone Hemisuccinate Cyclophosphamide Cytarabine Methotrexate |
Everolimus Sirolimus Dexamethasone Doxorubicin Prednisolone Vincristine Lenograstim Dexamethasone acetate Methylprednisolone acetate Prednisolone acetate Dexamethasone 21-phosphate Prednisolone phosphate BB 1101 Protective Agents Physiological Effects of Drugs |