Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Fibrosarcoma

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Cytarabine

Endothelial Growth Factors

Mitogens

Idarubicin

Sorafenib

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Protein Kinase Inhibitors

Enzyme Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Tyrosine

Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m\^2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m\^2 IV over 24 hours daily (days 1-4)

12 mg/m\^2 IV over 1 hour daily (days 1-3)

1.5 g/m\^2 IV over 24 hours daily (days 1-4)

Ara-C

Farhad Ravandi-Kashani, MD

A primary goal of this clinical research study is to find the highest safe dose of sorafenib that can be given in combination with idarubicin and Ara-C for the treatment of acute myelogenous leukemia (AML) and high-risk, myelodysplastic syndrome (MDS).

Once the highest safe dose is found, researchers will then try to learn if this combination treatment can help control AML and high-risk MDS in newly diagnosed patients. The safety of this treatment combination will also be studied.

The Study Drugs:

Sorafenib is designed to block the function of important proteins in cancer cells. When active, these proteins help cause abnormal growth and behavior of leukemia cells.

Idarubicin and Ara-C are both designed to insert themselves into DNA (the genetic material of cells) and to stop DNA from repairing itself.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study.

If you are enrolled in the Phase I part of this study, the dose of sorafenib you receive with Ara-C and idarubicin will depend on when you enrolled in this study. Each new group of 3 participants will receive a higher dose level of sorafenib than the previous group until the highest safe dose of sorafenib that can be given in combination with Ara-C and idarubicin is reached.

If you are enrolled in the Phase II portion of this study, you will receive the highest safe dose of sorafenib in combination with Ara-C and idarubicin found in the Phase I part.

Study Drug Administration:

During the study, you will receive treatment over 28-day "cycles." The doses of idarubicin and Ara-C are the same for all study participants.

On Days 1-4 (Days 1-3 if you are older than 60) of each induction cycle (#1 and possibly #2), you will receive Ara-C through a nonstop infusion (through a needle in your vein). You will also receive steroids by mouth or through a vein every day to reduce the risks of side effects, such as rash.

On Days 1-3 of each induction cycle (#1 and possibly #2), you will receive idarubicin by vein over 1 hour once a day.

In general, sorafenib will be taken by mouth twice daily on Days 1-7, unless otherwise instructed. However, the dose of sorafenib may differ among study participants. Sorafenib should be taken with water on an empty stomach. Your study doctor will give you complete instructions on when and how to take sorafenib.

Depending on the side effects that you may have, the dose of sorafenib may be decreased, stopped until side effects go away, or even stopped completely, if your doctor thinks that this is in your best interest.

Study Visits:

During Cycles 1-2, you will have study visits about 2 times a week. You may need to have study visits more often when the study doctor thinks it is necessary. At these visits, you will have the following procedures performed.

* You will be asked about any side effects you may have experienced and any medications you may be taking.
* Blood (about 2 teaspoons) will be drawn for routine tests.

During Cycles 1 and 2, between Days 21-28, you will have a bone marrow aspirate and/or biopsy performed to check the status of the disease.

For Cycle 3 and in further cycles, you will have a bone marrow aspirate as determined necessary by your doctor. If your doctor thinks you have responded to the treatment, you will then have bone marrow aspirates collected every 3-6 months, if your doctor feels this to be necessary.

Consolidation Therapy:

If it is found that the disease is responding to treatment, you may receive 5 additional cycles of therapy. These cycles are called "consolidation" therapy and will be given every 4-6 weeks.

On Days 1-3, Ara-C will be given as a nonstop infusion. You will also receive steroids either by mouth or by vein to help reduce the risk of side effects.

On Days 1-2, idarubicin will be given by vein over 1 hour.

Sorafenib will be taken twice daily by mouth for 7 or more days, at a schedule determined by your study doctor.

After each cycle, about every 4-6 weeks, blood (about 2 teaspoons) will be drawn to check your blood count levels.

Maintenance Therapy:

After 5 cycles of consolidation therapy, and according to your response to consolidation therapy, you may continue on this study to receive "maintenance" treatment, as needed, and as determined by your study doctor for up to 7 more cycles.

You will take sorafenib twice a day every day during the 28-day cycle.

Every 1-4 weeks, blood (about 2 teaspoons) will be drawn for routine tests.

Length of Study:

You may receive up to 14 cycles in total of therapy. You may be taken off this study if the leukemia gets worse, develop another illness that interferes with taking the study drugs, or you have intolerable side effects.

This is an investigational study. Sorafenib is FDA approved and commercially available for the treatment of metastatic renal cancer only. Idarubicin is FDA approved for use in combination with other approved antileukemic drugs for the treatment of acute myeloid leukemia (AML) in adults. Cytarabine is FDA approved for use in the treatment of leukemia. The use of sorafenib combined with idarubicin and Ara-C in the treatment of AML and high-risk MDS is investigational and authorized for use in research only. Up to 75 patients will take part in this study. All patients will be enrolled at M. D. Anderson Cancer Center.

Phase I-II Study of Idarubicin, Cytarabine, and Sorafenib (BAY43-9006)

Phase I-II Study of Idarubicin, Cytarabine, and Sorafenib (BAY43-9006), an Oral Vascular Endothelial Growth Factor (VEGF), Rapidly Accelerated Fibrosarcoma (RAF) and FMS-like Tyrosine Kinase 3 (FLT3), in Patients With High-risk MDS and AML

MTD is dose level where grade 3-4 sorafenib-attributable toxicity in \<2 of 6 participants. Dose-Limiting Toxicity graded according to the NCI Common Toxicity Criteria version 3.0.

Complete response was defined by the presence of \< 5% blasts in the bone marrow (BM) with \> 1 x 10\^9/L platelets in the peripheral blood (PB).

Bayer

M.D. Anderson Cancer Center

Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)

Sorafenib + Idarubicin + Ara-C

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Farhad Ravandi-Kashani, M.D./Associate Professor

10 participants were treated with escalating doses of sorafenib with chemotherapy to establish the feasibility of the combination.

Maximum Tolerated Dose (MTD)

Complete Response

No Complete Response

Number of Participants With Complete Response

Overall Study

Heart and Blood Diseases

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Lymphoproliferative Disorders

Paraproteinemias

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Blood Protein Disorders

Hemorrhagic Disorders

Immunoproliferative Disorders

Lymphatic Diseases

Fludarabine

Fludarabine phosphate

Alemtuzumab

Antineoplastic Agents, Immunological

FLUDARABINE

CAMPATH 1H

FK50

Stem Cell Collection and Infusion

George Carrum, MD

1. To assess the treatment related mortality of allogeneic stem cell transplantation with non-myeloablative therapy incorporating the lymphodepleting MAb CAMPATH-1H, in patients with hematological diseases and renal cell carcinoma not eligible for conventional (myeloablative) therapy.
2. To assess the time to engraftment and incidence of graft failure in patients receiving this transplant regimen.
3. To assess the safety, pharmacokinetics and immunologic activity of CAMPATH-1H when used as part of a subablative conditioning regimen.

This is a two arm study in which outcomes will be assessed independently in recipients of HLA matched sibling transplants and recipients of unrelated or mismatched family donor transplants, although both groups will receive identical treatments.

The following will be given to the patient after admission:

Day - 6: Total body irradiation

Day - 5 to - 2: Fludarabine and Campath 1H

Day - 1: Day of rest

Day 0: Stem cell transplant (infusion)

Stem Cell Transplant for Patients With Blood Malignancy Using Donors and Less Toxic Chemotherapy With CAMPATH 1H

Phase I/II Study of Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancy, Using MHC Identical or Near Identical Donors and Sub-Myeloablative Conditioning With CAMPATH 1H (DIMSUM)

The Methodist Hospital Research Institute

Center for Cell and Gene Therapy, Baylor College of Medicine

Baylor College of Medicine

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase I-II Study of Idarubicin, Cytarabine, and Sorafenib (BAY43-9006)	NCT00542971	AML Acute Myeloid L... Myelodysplastic...	Idarubicin Sorafenib Ara-C	15 Years - 60 Years	M.D. Anderson Cancer Center
Stem Cell Transplant for Patients With Blood Malignancy Using Donors and Less Toxic Chemotherapy With CAMPATH 1H	NCT00048412	Myelodysplastic... Leukemia Multiple Myelom... Plasma Cell Dys... Lymphoprolifera...	FLUDARABINE CAMPATH 1H FK50 Stem Cell Colle...	- 70 Years	Baylor College of Medicine
Phase I-II Study of Idarubicin, Cytarabine, and Sorafenib (BAY43-9006)	NCT00542971	AML Acute Myeloid L... Myelodysplastic...	Idarubicin Sorafenib Ara-C	15 Years - 60 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for myelodysplastic disorders