Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Primary Myelofibrosis

Metaplasia

Blast Crisis

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Myeloid Leukemia

Acute Myeloid Leukemia

Chronic Graft Versus Host Disease

Acute Non Lymphoblastic Leukemia

Chronic Myeloid Leukemia

Acute Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Imatinib Mesylate

Vatalanib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

For 1 week prior to receipt of study combination regimen, all patients will receive single agent PTK 787 at dose specified for that dose level of the study combination regimen to allow stabilization of PTK 787 levels. Patients should not have a grade 3 or 4 PTK 787-related adverse events in order to begin study combination therapy with a imatinib on day 8. On Day 8, PTK 787 250 mg by mouth every day and imatinib 600 mg by mouth every day (for Acute Myelogenous Leukemia (AML), Chronic Myelogenous Leukemia- blastic phase (CML-BP) and imatinib 400 mg by mouth every day (for Agnogenic Myeloid Metaplasia (AMM). Length of therapy is four courses; each course equals 28 days. Patients assessed for response after each course.

For 1 week prior to receipt of study combination regimen, all patients will receive single agent PTK 787 at dose specified for that dose level of the study combination regimen to allow stabilization of PTK 787 levels. Patients should not have a grade 3 or 4 PTK 787-related adverse events in order to begin study combination therapy with a imatinib on day 8. PTK 787 250 mg by mouth for Days 1 - 7.

600 mg by mouth every day (for AML, CML-BP) for a 28 day cycle.

400 mg by mouth every day (for AMM) for a 28 day cycle.

Imatinib Mesylate (Gleevec)

For 1 week prior to receipt of the study combination regimen, all patients will receive single agent PTK 787 at the dose specified for that dose level of the study combination regimen to allow stabilization of PTK 787 levels.

Starting dose: 250 mg by mouth every day for a 28 day cycle.

PTK 787 (vatalanib)

The goal of this clinical research study is to find the highest safe doses of PTK 787 (vatalanib) and Gleevec (imatinib mesylate) that can be given to treat Chronic Myelogenous Leukemia-Blastic Phase (CML-BP), Refractory Acute Myelogenous Leukemia (AML), or Agnogenic Myeloid Metaplasia (AMM). Another goal is to see how effective this combination treatment is.

Rationale: The purpose of this study is to combine PTK-787, a potent orally vascular endothelial growth factor (VEGF) receptor inhibitor (in disorders where VEGF is known to be involved in the pathophysiology), with Imatinib mesylate (IM), a protein-tyrosine kinase inhibitor of abl, Bcr-Abl, platelet derived growth factor (PDGF), and c-Kit (in same disorders where these kinases are believed to be important). The potential synergy between oral agents that inhibit these kinases in disorders where each of the two agents have some, but inadequate, single agent activity is being studied in this protocol. We will also have an opportunity to assess if there is any correlation between response and individual kinase mutations e.g., c-Kit in patients with AML. If improved outcomes are observed, further studies will be indicated to investigate which, if either, agent is predominantly responsible for such a benefit - these studies will be facilitated by the availability of more potent e.g., (AMN107 as an abl inhibitor), (Bevacizumab, AG013736 as VEGF inhibitors) agents which will help to define the relative importance of the various inhibitory activities.

Objectives: To determine the maximum tolerated doses (MTD) and pharmacokinetics (PK) of PTK 787 and imatinib mesylate, when given in combination to patients with refractory acute myelogenous leukemia (AML), agnogenic myeloid metaplasia (AMM) and chronic myelogenous leukemia in blastic phase (CML-BP).

To determine the efficacy (response rate, survival, time to progression, time to treatment failure, duration of response) of the MTD in these study populations.

PTK 787 and Gleevec in Patients With AML, AMM, and CML-BP

Ph I/II Study of PTK 787 (Vatalanib) and Gleevec (Imatinib) in Patients With Refractory Acute Myelogenous Leukemia (AML), Agnogenic Myeloid Metaplasia (AMM), and Chronic Myelogenous Leukemia- Blastic Phase (CML-BP)

Time to response is defined as the period of time from the date of first study drug administration until the first objective documentation of response.

Novartis

M.D. Anderson Cancer Center

Immune System Diseases

Syndrome

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Hematologic Neoplasms

Leukemia, Lymphocytic, Chronic, B-Cell

Preleukemia

Myelodysplastic Syndromes

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Precancerous Conditions

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Lymphocytic Leukemia

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Farnesylthiosalicylic acid

Starting dose of 100 mg twice a day by mouth, Days 1 through 21 of a 28-day cycle.

Gautam Borthakur, MD

Primary Objective:

Determining the maximum tolerated dose (MTD) and pharmacokinetics (PK) of FTS (S-Trans, Trans-Farnesylthiosalicylic Acid) after daily oral administration on Days 1 through 21 of a 28-Day cycle to patients with advanced hematologic malignancies that have progressed following effective therapy or for which no effective therapy exists.

FTS is designed to interfere with a cancer cell's ability to reproduce.

Before you can start receiving the drug on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your complete medical history will be recorded, and you will have a physical exam. You will be asked about any side effects that you are having and about any medications that you are taking. Your weight and vital signs (blood pressure, heart rate, breathing rate, and temperature) will be measured. Blood (about 2 tablespoons) and urine will be collected for routine tests. You will be asked about your ability to perform everyday tasks. You will have an electrocardiogram (ECG - test to measure the electrical activity of the heart). A bone marrow aspirate and/or biopsy will be collected to check the status of the disease. To collect a bone marrow aspirate and/or biopsy, an area of the hip or chest bone is numbed with anesthetic and a small amount (about 1 teaspoon) of bone marrow and bone is withdrawn through a large needle. Women who are able to have children must have a negative blood (about 1 tablespoon) or urine pregnancy test.

If you are found to be eligible for this study, you will take FTS by mouth, morning and night with food, on Days 1-21 of a 28-day study "cycle."

The amount of study drug you will receive will be based on when you enter the study. At least 3 participants will be taking FTS at the same dose level. Doses will be increased for the next group of 3 participants based on the side effects seen in the previous group. Each new group of participants will receive a higher dose level than the previous group, until a level is reached where side effects are considered to be intolerable.

After each cycle, your doctor may decide to increase your dose if you are not having intolerable side effects and you are benefitting from the study drug. If you experience intolerable side effects during any of the cycles of therapy with FTS, your dose may be reduced, delayed, or you may be taken off the study.

On Day 1 of the study, your weight and vital signs will be measured. Blood (about 1 tablespoon) will be collected for routine tests. You will not take your evening dose of FTS on Day 1.

On Days 8,15, and 22 of the first cycle, your weight and vital signs will be measured. You will be asked about any side effects that you are having, and about any medications that you are taking. On Day 15 of Cycle 1, blood (about 1 tablespoon) will also be drawn for routine tests.

During Cycle 1, on Days 1, 8, and 15, blood (about 1 tablespoon per draw) will be drawn to find out how much drug there is in your blood at different time points. This will help researchers to learn how FTS is processed by your body. This is called pharmacokinetic (PK) testing. Blood will be drawn before your morning dose of FTS, at 30, 60, and 90 minutes after taking the morning dose, and at 2, 4, 6, 8 and 24 hours after taking the morning dose. During Cycle 1, on Days 1 and 15, blood (about 3 tablespoons per draw) will be drawn to determine how FTS works against leukemia cells. This blood will be drawn before and 24 hours, after taking the morning dose on Day 1 and before you take the dose on Day 15.

On Day 1 of each cycle after Cycle 1, your weight and vital signs will be measured. Blood (about 2 tablespoons) and urine will be collected for routine tests. You will be asked about your ability to perform everyday tasks. You will be asked about any side effects that you are having, and about any medications that you are taking.

On Days 8, 15, and 22 of every cycle after Cycle 1, you will be asked about any side effects that you are having and about any medications that you are taking. On Day 15, blood (about 1 tablespoon) will also be drawn for routine tests, and your weight and vital signs will be measured.

You may remain on study for as long as you are benefiting. You will be taken off study if you are not benefitting or if you are experiencing intolerable side effects.

Thirty (30) days after you are no longer taking the study drug, you will have an end-of-study visit. Blood (about 2 tablespoons) and urine will be collected for routine tests. Your weight and vital signs will be measured. You will be asked about your ability to perform everyday tasks. You will be asked about any side effects that you are having, and about any medications that you are taking. You will have an ECG and an evaluation of your disease, which may include a bone marrow aspiration and/or biopsy.

This is an investigational study. FTS is not FDA approved or commercially available, and it has been authorized for use in research only. Up to 30 patients will take part in this multicenter study. Up to 20 patients will be enrolled at M. D. Anderson.

FTS Study in Patients With Advanced Hematologic Malignancies

A Phase I Open-Label Study of S-Trans, Trans-Farnesylthiosalicylic Acid (FTS) Administered on Days 1 to 21 of a 28 Day Cycle in Patients With Advanced Hematologic Malignancies

Concordia Pharmaceuticals, Inc

Skin and Connective Tissue Diseases

Mastocytosis

Polycythemia Vera

Polycythemia

Hypereosinophilic Syndrome

Bone Marrow Neoplasms

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Mast Cell Activation Disorders

Eosinophilia

Leukocyte Disorders

Myelodysplastic-Myeloproliferative Diseases

Myelodysplastic/myeloproliferative Disease

Dasatinib

Dasatinib (BMS-354825)

Hagop M Kantarjian, MD

The goal of this clinical research study is to learn if dasatinib can help to control myeloproliferative disorders. The safety and tolerability of dasatinib will also be studied.

Dasatinib is an experimental anti-cancer drug that is designed to block the function of BCR-ABL, which is the abnormal protein responsible for causing leukemia in some cells.

If you are found to be eligible to take part in this study, you will take dasatinib by mouth twice a day. If you have mastocytosis, you will take dasatinib by mouth once a day. A treatment cycle will be defined as 4 weeks (28 days) + 7 days. You will be instructed to take dasatinib in the morning (between about 6:00 a.m.-10:00 a.m.) and in the evening (between about 6:00 p.m.-10:00 p.m.).

Blood tests (about 2 - 3 teaspoons) will be done once a week for a month, then once a month for 5 years, then once every 6 months (if your doctor thinks it is needed) for the remainder of your treatment on this study. A bone marrow biopsy will be done after 1-2 months of therapy to document response.

Dasatinib will be given for as long as you are responding. You will be taken off study if the disease gets worse or intolerable side effects occur.

This is an investigational study. Dasatinib is authorized for use in research only. A total of 145 patients will take part in this study. All will be treated at MD Anderson.

Dasatinib as Therapy for Myeloproliferative Disorders (MPDs)

Therapy of Myeloid Metaplasia-Myelofibrosis, Atypical Chronic Myeloid or Myelomonocytic Leukemia, C-Kit Positive Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (AML-MDS), Hypereosinophilic Syndrome, Polycythemia Vera, and Mastocytosis With Dasatinib (BMS-354825)

Response Rate is complete response plus partial response (CR+PR) for each disease category. Response Evaluation Criteria are as follows:

Systemic Mastocytosis (SM): CR is the improvement of C-Findings, Tryptase \<20, and no organomegaly. PR is the improvement of C-Findings.

Acute Myeloid Leukemia (AML)/MDS and CMML: CR is bone marrow blasts \</= 5%, absolute neutrophil count (ANC) \>/= 1000 and platelets \>/= 100. PR is bone marrow blasts 6-25% but decreased by \> 50% and absolute neutrophil count, absolute neutrophil count (ANC) \>/= 1000 and platelets \>/= 100.

Primary Myelofibrosis (PMF): CR is bone marrow blasts \</= 5%, absolute neutrophil count (ANC) \>/= 1000 and platelets \>/= 100. CR is PR plus one or more of the following: ANC \>/= 1000, decreased platelets by 50%, hemoglobin increase of 2g/dl or reduction splenomegaly and/or hepatomegaly by 50%.

HES/CEL: CR is disappearance of eosinophilia \</= 10%, PR is reduction of eosinophilia by \>/= 50%

Response date to loss of response or last follow up.

Bristol-Myers Squibb

Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily

Dasatinib All Patient Groups

Acute Myeloid Leukemia (AML)

MDS/CMML

HES/CEL

Primary Myelofibrosis (PMF)

Systemic Mastocytosis (SM)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

The outcome measures were collected and reported by participant diagnosis group. The Other Adverse Events and Serious Adverse Events were collected and recorded as a group for all participants registered on the study.

Hagop Kantarjian, MD/Department Chair

Participant Response Rate

The number of participants analyzed for duration of response reflects the number of participants with a response for each arm.

Duration of Response (Survival)

Overall Study

Triciribine 15 mg/m\^2 intravenous (IV) Weekly Over 1 Hour On Days 1, 8, and 15.

15 mg/m\^2 IV Weekly Over 1 Hour On Days 1, 8, and 15.

Triciribine

Farhad Ravandi-Kashani, MD

Primary objective:

To determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of TCN-PM (Triciribine) when administered as an approximately one-hour intravenous infusion on a weekly schedule on days 1, 8 and 15 in a 28 day cycle in patients with advanced hematologic malignancies;

To determine the pharmacokinetics (PK) of Triciribine following study drug administration.

Secondary objective:

To observe the anti-tumor effects of Triciribine, if any occur

Triciribine is designed to prevent development of certain proteins which participate in the abnormal growth of cancer cells.

Before you can start treatment on this study, you will have "baseline tests." These tests will help the doctor decide if you are eligible to take part in the study. You will have a physical exam, including measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate). Your complete medical history will be recorded. You will be asked about your ability to perform everyday activities. You will have blood (about 4 teaspoons) and urine collected for routine tests. You will have an electrocardiogram (ECG - a test to measure the electrical activity of the heart). Women who are able to have children must have a negative blood (about 1 teaspoon) or urine pregnancy test.

You will also have a bone marrow aspiration and/or biopsy performed during the baseline testing. To collect a bone marrow aspirate and biopsy, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle.

Certain patients who are at risk for involvement of disease in their central nervous system may be required to have a lumbar puncture (spinal tap) done. A lumbar puncture involves inserting a needle between the vertebrae of the back and then removing a small amount of spinal fluid. The fluid will be checked for diseased cells, used to measure the level of study drug in the fluid, and used to measure the level of a substance that shows how the study drug is being handled by your body.

If you are found to be eligible for this study, you will start receiving Triciribine through a needle in a vein, over about 1 hour, on Days 1, 8, and 15 of each 28-day study "cycle." On each day you receive Triciribine, your vital signs will be measured before the start of the infusion, at 30 minutes (half-way through the infusion), at the end of the infusion, and at 1 hour after completing the infusion. An ECG will be done at the end of the infusion on Day 1 of the first cycle only.

The amount of Triciribine you receive in each infusion will depend on when you enter the study. At least 3 participants will be enrolled at each dose level. Each new group of participants will receive a higher dose level than the group before, unless a level is reached where the side effects are considered intolerable. This will help researchers to find out the highest tolerable dose of Triciribine.

During the study, researchers will be checking the status of the cancer to see how it is responding to the study drug. You will be checked once a week, or more often, depending on how you are doing and according to your blood cell counts. Each check-up includes measurement of your vital signs and blood (about 4 teaspoons) drawn for routine tests. You will be asked about any side effects you may have experienced and any medications you are taking.

During Cycle 1, you will have blood samples (about 1 teaspoon each time) drawn to measure the amount of study drug in your blood at different times. This is called pharmacokinetic (PK) testing. During Cycle 1, you will have a blood sample drawn before receiving the first dose of Triciribine, and then 2, 24, 48, 72 ,and 96 hours after the Day 1 Triciribine dose. If your doctor decides that it is necessary, an additional blood sample will also be drawn between 120 and 144 hours (about 5-6 days) after your Day 1 dose of Triciribine. During Cycle 1, you may also have blood samples (about 1 teaspoon) drawn to measure the action of the study drug in the tumor cells. This is called pharmacodynamic studies (this defines how the drug works on the tumor cells). During Cycle 1, you will have a blood sample drawn (about 1 teaspoon) before receiving the first dose of triciribine and then 2 and 24 hours after the Day 1 triciribine dose.

Before receiving each additional cycle, you will have a physical exam, including vital signs. Blood (about 4 teaspoons) will be drawn for routine tests, and urine will be collected. You will be asked about your ability to perform everyday activities. You will have a bone marrow exam (including aspiration and/or biopsy) about every 28 days, in order to check your response.

Certain participants who are at risk for involvement of disease in their central nervous system may be required to have repeat lumbar punctures (spinal taps) performed once a week.

You may move to a higher dose level after your first cycle of therapy, if that increased dose level is considered safe and the disease is stable or responding to treatment. If, however, you experience serious side effects from the therapy, the doctor may decide to hold any further therapy with Triciribine until those side effects go away, or may decide to stop therapy altogether, if the side effects are intolerable. Depending on how fast the side effects go away, you may be able to re-start your Triciribine infusions at a lower dose.

You may continue to receive Triciribine on study with no limit to the number of cycles that you can receive, as long as your doctor finds that you are benefiting from this therapy and you are not experiencing intolerable side effects. On the other hand, you may stop receiving the study drug and be taken off study if it is not effective for you and/or the disease gets worse, you develop another illness that interferes with the ability to safely give you the study drug, or you are unable to tolerate the study drug.

If you leave the study for any reason, you will be asked to return for a follow-up visit at the end of therapy (and possibly 30 days after your last dose of Triciribine, if you are not receiving another type of treatment). A physical exam will be performed, and blood (about 2 teaspoons) will be drawn for routine tests, during both of these visits. If you have side effects that are possibly related to the treatment, you may need to have more follow-up visits. Blood (up to 3 tablespoons) may need to be drawn for routine tests at that time.

THIS IS AN INVESTIGATIONAL STUDY. Triciribine has been authorized by the FDA for use in research only. Up to 34 patients will take part in this multicenter study. Up to 30 patients will be enrolled at M. D. Anderson.

Triciribine Phosphate Monohydrate (TCN-PM, VD-0002) in Adult Patients With Advanced Hematologic Malignancies

A Phase I Study of Triciribine Phosphate Monohydrate (TCN-PM, VD-0002) in Adult Patients With Advanced Hematologic Malignancies

The MTD is the highest dose level in which \<2 patients of 6 develop first cycle dose-limiting toxicity (DLT). Evaluations after each dose level (28 day cycle).

VioQuest Pharmaceuticals

Prescient Therapeutics, Ltd.

Leukemia, Myelomonocytic, Acute

Gleevec administered orally at a pre-determined dose once daily.

400mg orally once daily until disease progression or unacceptable side effects

Imatinib mesylate

Daniel J. DeAngelo, MD, PhD

The purpose of this study is to determine the effects (good and bad) of Gleevec in patients with BCR-negative myeloproliferative disorders including myelofibrosis with myeloid metaplasia and chronic myelomonocytic leukemia.

Gleevec will be administered at a dose of 400 mg orally once daily.

Patients will continue to receive the drug until either drug progression or the development of intolerable side effects.

Patients will be assessed with a complete blood count weekly for the first 8 weeks and will have monthly physical examinations and bone marrow examinations every 3 months.

A Study of Gleevec in Patients With Idiopathic Myelofibrosis or Chronic Myelomonocytic Leukemia (CMML)

A Phase II Study of Gleevec (Imatinib Mesylate) In Patients With BCR-Negative Myeloproliferative Disorders Including Patients With Idiopathic Myelofibrosis With Myeloid Dysplasia or Chronic Myelomonocytic Leukemia

Brigham and Women's Hospital

Massachusetts General Hospital

Dana-Farber Cancer Institute

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PTK 787 and Gleevec in Patients With AML, AMM, and CML-BP	NCT00088231	Acute Myelogeno... Agnogenic Myelo... Chronic Myeloge...	Imatinib Mesyla... PTK 787 (vatala...	15 Years -	M.D. Anderson Cancer Center
FTS Study in Patients With Advanced Hematologic Malignancies	NCT00867230	Myelodysplastic... Leukemia	FTS	18 Years -	M.D. Anderson Cancer Center
Dasatinib as Therapy for Myeloproliferative Disorders (MPDs)	NCT00255346	Acute Myeloid L... Myelodysplastic... Agnogenic Myelo... Myelofibrosis Hypereosinophil... Polycythemia Ve... Mastocytosis Leukemia, Myelo...	Dasatinib (BMS-...	18 Years -	M.D. Anderson Cancer Center
Dasatinib as Therapy for Myeloproliferative Disorders (MPDs)	NCT00255346	Acute Myeloid L... Myelodysplastic... Agnogenic Myelo... Myelofibrosis Hypereosinophil... Polycythemia Ve... Mastocytosis Leukemia, Myelo...	Dasatinib (BMS-...	18 Years -	M.D. Anderson Cancer Center
Dasatinib as Therapy for Myeloproliferative Disorders (MPDs)	NCT00255346	Acute Myeloid L... Myelodysplastic... Agnogenic Myelo... Myelofibrosis Hypereosinophil... Polycythemia Ve... Mastocytosis Leukemia, Myelo...	Dasatinib (BMS-...	18 Years -	M.D. Anderson Cancer Center
Triciribine Phosphate Monohydrate (TCN-PM, VD-0002) in Adult Patients With Advanced Hematologic Malignancies	NCT00642031	Hematologic Mal... Leukemia	Triciribine	-	Prescient Therapeutics, Ltd.
A Study of Gleevec in Patients With Idiopathic Myelofibrosis or Chronic Myelomonocytic Leukemia (CMML)	NCT00136409	Myelofibrosis Myeloid Metapla... Agnogenic Myelo... Chronic Myelomo...	Imatinib mesyla...	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for agnogenic myeloid metaplasia