Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Rare Diseases

Lymphoma

Meningeal Carcinomatosis

Meningeal Neoplasms

Meningitis

Neuroinflammatory Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Lymphosarcoma

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Micronutrients

Hematinics

Vitamins

Cytarabine

Methotrexate

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immunosuppressive Agents

Immunologic Factors

Antiviral Agents

Folinic Acid

Folate

Vitamin B9

Intrathecal (injected into the spinal fluid) DepoCyt

Intrathecal methotrexate

Intrathecal cytarabine (also known as ara-C)

Ahmet Tutuncu, MD, PhD

The purpose of this study is to find out how well an experimental drug called DepoCyt works for neoplastic meningitis (cancer that has spread to the tissues around the brain and spinal cord). DepoCyt is a new slow-release form of the cancer drug called ara-C (cytarabine). Cytarabine has been used for many years to treat cancer.

DepoCyt Therapy in Patients With Neoplastic Meningitis From Lymphoma or a Solid Tumor

A Randomized Clinical Study to Determine the Patient Benefit and Safety of Depocyt (Cytarabine Liposome Injection) for the Treatment of Neoplastic Meningitis

Pacira Pharmaceuticals, Inc

Skin and Connective Tissue Diseases

Neoplasm Metastasis

Breast Neoplasms

Neoplasms, Second Primary

Brain Neoplasms

Breast Diseases

Skin Diseases

Neoplastic Processes

Brain Diseases

Central Nervous System Diseases

Etoposide

Bevacizumab

Cisplatin

Etoposide phosphate

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Bevacizumab (15mg/kg) on D1, etoposide (70mg/m2) on D2-D4, cisplatin (70mg/m2) on D2; 21 days a cycle, for a maximum of 6 cycles

Bevacizumab, etoposide, cisplatin

Additional intrathecal methotrexate only given in patients with leptomeningeal metastasis

Yen-Shen Lu, MD, PhD

The main purpose of this study is to investigate the efficacy of bevacizumab, etoposide and cisplatin in treating breast cancer patients with central nervous system metastasis (including brain parenchymal and leptomeningeal metastasis).

Brain metastases are increasingly important causes of morbidity and mortality in breast cancer patients. Whole brain radiotherapy (WBRT) and surgery remains the standard treatment for brain metastases. However, the median overall survival after brain and leptomeningeal metastasis were only 8.5 months and 16 weeks respectively There is lack of standard treatment for brain metastasis progression post WBRT. Chemotherapy was considered mostly poor for treatment response because of the blood brain barrier. However, this has been questioned because tumor can disrupt the normal function of blood brain barrier. For example, etoposide and cisplatin had been used for treatment for breast cancer patients with brain metastasis. The overall response rate of central nervous system (CNS) was 39 %, disease control rate was 60%, although the median overall survival was 31 weeks only. The role of targeted therapies is actively being assessed. Recently, a phase II study of lapatinib in patients with brain metastases from HER2-positive breast cancer showed that CNS objective response rates were 6% to lapatinib monotherapy and 20% to lapatinib plus capecitabine. Although the result is promising, the treatment population is limited in the HER2 overexpression breast cancer.

Bevacizumab, an anti-angiogenic agent, has been approved to combine with several chemotherapy agents in breast, lung and colon cancer. It was once considered contraindicated in patients with brain metastases due to the possibility of intracranial bleeding. However, two studies involving the use of bevacizumab for treating brain metastatic tumors of non-squamous or peripherally located squamous lung cancer showed no report of brain hemorrhage. In addition, bevacizumab has been approved to treat primary brain aggressive tumors recently.

In the institution, the investigators treated three breast cancer patients with multiple brain metastases using bevacizumab plus etoposide and cisplatin (B-EP). All of them have been treated for at least two lines of chemotherapy before brain metastases occurred. All of them received WBRT for brain metastases and one of them also received craniotomy with brain tumor resection plus local stereotactic radiosurgery. The follow up magnetic resonance imaging (MRI) had revealed recurrent metastatic brain tumors in one patients, and recurrence of leptomeningeal metastasis in another two patients. One patient who has multiple brain parenchyma metastases showed objective response on MRI after two cycle of B-EP treatment, and remained progression free for more than 5 months. The other two patients with leptomeningeal metastasis had intrathecal and intraventricular (via Ommaya reservoir) methotrexate treatment for more than eight doses. They were near stupor before B-EP treatment. Both had best clinical response of full recovery of consciousness and absence of cancer cells in cerebrospinal fluid. One survived eight months after the diagnosis leptomeningeal metastasis, and the other two were still alive six months after the diagnosis of leptomeningeal metastasis .

Dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) has been used in various studies for evaluation of anti-angiogenic condition. In breast cancer, DCE-MRI has been used as an early predictive marker for response. Glioblastoma patients have also been evaluated with DCE-MRI to determine reduction of vessel permeability after bevacizumab treatment.

Proton magnetic resonance spectroscopy (1H-MRS) has been used to different benign brain tumors from malignant ones. The utilization of 1H-MRS, especially in human brain tumors, coupled to both routine MRI and functional MRI techniques provides greater information concerning tumor grading and extension and characterization of the normal surrounding tissue than what is possible with any other imaging technique alone. To analyze proton spectroscopy before and after bevacizumab may give us further information about the mechanism of B-EP on CNS metastasis.

Therefore, the investigators propose to conduct a phase II clinical trial to test the efficacy of B-EP regimen in breast cancer patients with CNS metastasis along with brain DCE-MRI to demonstrate the antiangiogenesis efficacy.

Bevacizumab With Etoposide and Cisplatin in Breast Cancer Patients With Brain and/or Leptomeningeal Metastasis

A Phase II Study of Bevacizumab With Etoposide and Cisplatin in Breast Cancer Patients With Brain and/or Leptomeningeal Metastasis

The response criteria for brain parenchymal metastasis is measured according to the volumetric response criteria with modification. CNS lesion(s) which have a ≧ 50% volumetric reduction of in the absence of progressive neurologic signs and symptoms will be considered as responsive.

The response criteria for leptomeningeal metastasis is defined as disappearance of carcinoma cells of three consecutive cytology examination of cerebrospinal fluid (CSF) after chemotherapy. For patients with both brain and leptomeningeal metastases, both criteria need to be met to be considered as responsive.

To observe the toxicity profile of B-EP according to CTCAE 3.0

To use volumetric measurement by subtraction image of CT the tumor before and after contrast enhancement; assessed every 9 weeks until best response measured

A response is defined as the CSF cytology examination turns from positive to negative. A confirmed response is defined as CSF cytology examination remains negative for two or three consecutive tests

To evaluate the response rate of extra-CNS lesions according to RECIST. Measure every 9 weeks until best response recorded

vascular activity detected with dynamic contrast enhanced magnetic resonance imaging (DCE-MRI), measured before treatment, 24 hours after bevacizumab administration and end of 1st cycle of B-EP

Prognostic and predictive value of biomarkers in CSF or serum. Serum will be drawn before treatment, end of cycle one and end of 6 cycles of treatment or time of progression

Drug concentrations of bevacizumab, etoposide in CSF, blood and CSF/blood ratio before and after B-EP treatment in cycle one and cycle two

To evaluate the response rate and duration of response of CNS metastasis regarding to prior exposure to cisplatin

To evaluate the characteristics of 1H-MRS of metastatic brain tumor before and after B-EP treatment

Taipei Veterans General Hospital, Taiwan

Taichung Veterans General Hospital

Chang Gung Memorial Hospital

National Taiwan University Hospital

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Philadelphia Chromosome

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Cyclophosphamide

Dexamethasone

Prednisone

Vincristine

Daunorubicin

Dexamethasone acetate

Pegaspargase

Mercaptopurine

Thioguanine

BB 1101

Antineoplastic Agents, Alkylating

Alkylating Agents

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

HIV Protease Inhibitors

Protease Inhibitors

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

All patients received phase 1 of induction therapy, which consisted of daunorubicin,vincristine,Pegaspargase,prednisone and methotrexate (intrathecally).Patients went on to phase 2 at the end of phase 1.Phase 2 therapy consisted of cyclophosphamide,cytarabine,6-Mercaptopurine and methotrexate intrathecally. After Induction therapy, all patients received intensification therapy with high-dose methotrexate followed by Pegaspargase. After intensification therapy,patients received consolidation(cytarabine, etoposide,Pegaspargase,dexamethasone,vincristine,cyclophosphamide,daunorubicin,thioguanine)and maintenance therapy(vincristine,6-mercaptopurine,methotrexate

,prednisone). Intrathecal methotrexate and intrathecal cytarabine were given as CNS prophylaxis.

induction therapy I：1.4 mg/m2 IV d1, 8, 15, 22； consolidation therapy(Cycle 1)：1.4 mg/m2 IV d1, 8, 15, 22； Maintenance therapy: 1.4 mg/m2 intravenously every 3 months for a total of 2.5 years

induction therapy I：60 mg/m2 IV d1, 8, 15, 22； consolidation therapy(Cycle 3)：25 mg/m2 IV d1, 8, 15, 22；

induction therapy I: 2500U/m2,im,d8,22 Intensification therapy:2500U/m2 im, d2,23 consolidation therapy(Cycle 2，4)：2500U/m2 im, d1

induction therapy I：60 mg/m2 PO d1-28; Maintenance therapy:prednisone 60 mg/m2 orally for 5 days every 3 months for a total of 2.5 years

induction therapy I：12.5 mg IT d15 induction therapy II：12.5 mg IT d1, 8, 15, 22

Intrathecal Methotrexate

induction therapy II:650 mg/m2 IV d1, 15, 29 consolidation therapy(Cycle 3)：650 mg/m2 IV，d29

induction therapy II:75 mg/m2 IV d1-4, 8-11, 15-18, 22-25 consolidation therapy(Cycle 1，2，4)：75 mg/m2 intravenously on days 1 to 5 consolidation therapy(Cycle 3):75 mg/m2 intravenously on days 31 to 34 and 38 to 41

induction therapy II:60 mg/m2 PO d1-28 Maintenance therapy:75 mg/m2 orally each day for a total of 2.5 years

6-Mercaptopurine

Intensification therapy:3 g/m2 intravenously given on days 1, 8, and 22 Maintenance therapy:20 mg/m2 orally or intravenously once a week for a total of 2.5 years.

consolidation therapy(Cycle 1，2，4)：100 mg/m2 intravenously on days 1 to 5

consolidation therapy(Cycle 1)：10mg/m2 orally on days 1 to 28

dexamethasone

consolidation therapy(Cycle 3): 60 mg/m2 orally on days 29 to 42

thioguanine

50 mg intrathecal cytarabine was given on 4 occasions 3 months apart during maintenance therapy.

intrathecal cytarabine

hua wang, MD.

yue lu, MD.

This prospective study was conducted to evaluate the efficacy and safety profiles of Modified MRCUKALLⅫ/ECOGE2993 Regimen in young adults with newly diagnosed, low-risk, Philadelphia chromosome negative acute lymphoblastic leukaemia.

All patients received a modified BFM regimen which was derived from the MRCUKALLⅫ/ECOGE2993 Regimen.The differences were as follows:(1) cranial prophylactic radiotherapy was omitted (2) Pegaspargase was used instead of L- asparaginase for patient.(3)Two additional Pegaspargase treatments were added into consolidation therapy.

Modified MRCUKALLⅫ/ECOGE2993 Regimen for ALL

A Prospective Phase II Trial of Modified MRC UKALL Ⅻ/ECOG E2993 Regimen in the Treatment of Low Risk Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia for Young Adults

including hematological safety and non-hematological safety.

Minimal residual disease is measured in bone marrow using an multiparameter flow cytometry.For the patients who achieved complete remission after induction therapy, if two consecutive tests for MRD were positive,we will define it as MRD positive

Sun Yat-sen University

professor

Lymphoma, Non-Hodgkin

Doxorubicin

Liposomal doxorubicin

Asparaginase

Induction + Maintenance: Daunorubicin, Vincristine, PEG-asparaginase, Intrathecal Methotrexate, Cyclophosphamide, Cytarabine, Mercaptopurine, Doxorubicin, Thioguanine

Starting Dose 2000 International units/m2 by vein in week 1

PEG-asparaginase

Starting Dose 12 mg on week 2 and week 5 injected into spinal fluid

Starting Dose 1g/m2 by vein in weeks 1 and 5

75 mg/m2 subcutaneous or by vein for four consecutive days on days 1-4 and days 8-11 of both months

Starting Dose 60 mg/m2 by mouth on days 1-14 of each month

Starting Dose at 100 mg/m2 by vein and escalating by 50 mg/m2/dose every 10

+/- 2 days for 5 doses to toxicity (e.g myelosuppression or mucositis grade 3

Michael E. Rytting, M.D.

Objectives:

A. Primary objective:

1 To assess the feasibility and the effectiveness of pediatric type therapy (augmented BFM) in patients age 12 through 40 with untreated precursor-B or T acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL).

B. Secondary objective:

1. To evaluate the prognostic significance of minimal residual disease in bone marrow samples at the end of induction and at the end of consolidation in this group of patients.
2. To prospectively evaluate gene hypermethylation status in this group of patients.
3. To prospectively analyze asparaginase activity and anti-asparaginase antibody formation in this population of patients.

Induction:

During Induction, you will receive augmented Berlin-Frankfurt-Munster chemotherapy, which is made up of a combination of Cerubidine®, Daunorubicin Hydrochloride (daunorubicin), Oncovin® (vincristine), prednisone, dexamethasone, Oncaspar® (PEG Asparaginase), and MTX amethopterin (methotrexate). All of these drugs are designed to interfere with the multiplication of cancer cells to cause them to die and to keep the cancer from coming back.

If you are found to be eligible to take part in this study, on Day 1 or during the spinal tap procedure, you will be given cytarabine as an injection in your spinal fluid. Within 3 days, you will begin the Induction course, which will last for 4 weeks.

Daunorubicin and vincristine will be given through a needle in your vein on Days 1, 8,15, and 22. During the first week of therapy, you will be given 1 infusion of PEG Asparaginase by vein. You will take prednisone by mouth on Days 1-28. Methotrexate will be injected into your spinal fluid on Weeks 2 and 5 during your spinal tap. Cerebrospinal fluid (CSF) studies will be sent with each spinal tap to test the fluid for leukemia. If there is disease in your spinal fluid before starting the treatment, you will be given additional methotrexate doses once a week until there is no disease present. You will continue to receive methotrexate in spinal taps every other week for 8 doses, then monthly for 6 doses.

Blood (about 3 teaspoons) will be drawn multiple times during the study for routine tests. You will have a bone marrow aspirate or biopsy on Days 15 and 29 and then as needed to confirm remission.

If you have less than 5% immature cells in the bone marrow, 1 week after Induction, you will continue treatment with Consolidation 1. If you achieved remission after 4 weeks of Induction treatment, you will then have treatment with Consolidation 1, which will be discussed in a separate informed consent document.

If you have LL and had no bone marrow involvement at screening, you will have a chest x-ray, CT scans, and PET scans to measure the disease. Consolidation 1 and other phases of chemotherapy will be discussed in a separate informed consent document.

If you still have more than 5% leukemia cells in the bone marrow after Induction therapy, you will receive 2 extra weeks of therapy called "Extended Induction" before going to the next phase of therapy. You will receive daunorubicin by vein on Day 1. You will receive vincristine on Weeks 1 and 2 by vein. You will take prednisone by mouth on Days 1-14. You will receive PEG Asparaginase by vein in the first week of the Extended Induction. Blood (about 3 teaspoons) will be drawn weekly during the Extended Induction period for routine tests.

At the end of the Extended Induction period, you will have a physical exam and a bone marrow aspirate or biopsy to learn your response to treatment.

After Extended Induction, if the disease is in remission, then you will have 1 course of Consolidation 1, 2 courses of Consolidation 2, and 2 courses of Consolidation 3 before proceeding to Maintenance therapy. A separate discussion and informed consent document for Consolidation and Maintenance will be provided.

Length of Study:

You may remain on study for as long as you are benefiting. However, if after Extended Induction, the disease is not in remission, you will be taken off study, and your doctor will discuss other treatment options with you.

You may be taken off study if the disease gets worse or comes back during treatment, intolerable side effects occur, new information becomes available to your study doctor, if your doctor thinks it is in your best interest, or if you do not attend your appointments, which are scheduled at least once every 3 months.

This is an investigational study. The chemotherapy drugs used in this study are FDA approved and commercially available. Up to 125 patients will take part in this study. All will be enrolled at MD Anderson.

Consolidation and Maintenance:

During Consolidation, you will receive cyclophosphamide, cytarabine, 6-mercaptopurine, vincristine, PEG asparaginase, methotrexate, doxorubicin, 6-thioguanine, and dexamethasone. During Maintenance, you will receive, vincristine, dexamethasone, 6-mercaptopurine, and methotrexate. All of these drugs are designed to interfere with the multiplication of cancer cells to cause them to die and to keep the cancer from coming back.

If you achieved remission after 4 weeks of induction treatment, you will have treatment with Consolidation 1, Consolidation 2, Consolidation 3 (Parts A and B), and then you will proceed to Maintenance therapy.

If the level of blast cells in your blood is above a certain level at Day 15 of Induction but you achieved complete remission by Day 29, or if you achieved remission after 6 weeks of induction plus extended induction, then you will receive 1 course of Consolidation 1, 2 courses of Consolidation 2, 2 courses of Consolidation 3 (Parts A and B), and then you will proceed to maintenance therapy.

Consolidation 1 will last for 8 weeks (2 months). You will receive cyclophosphamide through a needle in your vein on Weeks 1 and 5. Cytarabine will be given as an injection just beneath the skin or by vein on or around Days 1-4 and Days 8-11 of each month. 6-Mercaptopurine will be taken by mouth on Days 1-14 of each month. Vincristine will be given by vein on Weeks 3-4 of each month. PEG Asparaginase will be given by vein on Week 3 and 6 of each month. You will receive methotrexate through a needle through your spine weekly during Month 1 only. Blood (about 3 teaspoons) will be drawn for routine tests. You will have a spinal tap with spinal fluid tests during the intrathecal methotrexate dose. A spinal tap (also called a lumbar puncture) is when a special needle is inserted into the lower back through the space between the bones to draw a sample of the fluid that surrounds the spinal cord. You will have a bone marrow aspiration at the end of Month 2. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle.

Consolidation 2 will last for 7 weeks. You will receive vincristine and methotrexate by vein every 10 plus or minus 2 days for 5 doses. You will receive PEG Asparaginase by vein in Weeks 1 and 4. You will receive intrathecal methotrexate in Weeks 1 and 5. You will have a spinal tap with spinal fluid tests during the intrathecal methotrexate dose. Blood (about 3 teaspoons) will be drawn every 2 weeks for routine tests.

Consolidation 3 (Part A) will last for 4 weeks. You will receive vincristine and Doxorubicin by vein in Weeks 1, 2 and 3. Dexamethasone will be taken by mouth on Days 1-7 and Days 15-21. You will receive PEG Asparaginase by vein on Week 1. You will receive intrathecal methotrexate in Week 1.

Consolidation 3 (Part B) will last for 4 weeks. You will receive cyclophosphamide by vein in Week 1. You will receive cytarabine by vein or as an injection for 4 days in a row in Weeks 1-2. You will take 6-Thioguanine by mouth every day for the first 2 weeks. You will receive intrathecal methotrexate in Weeks 1 and 2. You will receive vincristine by vein on Weeks 3 and 4. You will receive PEG Asparaginase by vein on Week 3.

During Consolidation 3 (Part A and B), blood (about 3 teaspoons) will be drawn at least weekly for routine tests. Spinal fluid tests will be sent with each intrathecal methotrexate dose. Spinal taps will be done during each intrathecal chemotherapy dose

Once you finish Consolidation, you will proceed to maintenance therapy.

The Maintenance period for ALL patients will last for 24 months. If you have ALL, you will receive vincristine by vein every month. You will take dexamethasone by mouth for 5 days every month. You will take 6-Mercaptopurine by mouth once daily. You will take methotrexate by mouth every week. You will receive intrathecal methotrexate every 3 months for the first 12 months of maintenance. You will have a spinal tap with spinal fluid tests during the intrathecal methotrexate dose.

Maintenance for patients with LL will also last for 24 months. If you have LL, you will receive vincristine by vein every month. You will take dexamethasone by mouth for 5 days every month.

You will take 6-Mercaptopurine by mouth once daily. You will take methotrexate by mouth every week.

During the Maintenance period, all participants will have blood samples (about 1 to 3 teaspoons each time) drawn every 3 months for routine tests.

If you have LL, you will have an additional positron emission tomography (PET) scan and computed tomography (CT) scan at the end of the Maintenance period.

Follow-Up Visits:

Your study doctor will inform you of your follow-up visits in the clinic. At each follow-up visit there will be a physical exam and complete blood count. You will be followed-up for the next 3 years after your the last dose of your chemotherapy.

Length of Study:

You may remain on study for as long as you are benefiting. You may be taken off study if the disease gets worse or comes back during treatment, intolerable side effects occur, new information becomes available to your study doctor, if your doctor thinks it is in your best interest, or if you do not attend your appointments, which are scheduled at least once every 3 months.

This is an investigational study. The chemotherapy drugs used in this study are all FDA approved and commercially available. Up to 125 patients will take part in this study. All will be enrolled at MD Anderson.

Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma

Augmented Berlin-Frankfurt-Munster Therapy for Adolescents/Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

3-year EFS was calculated based on the participants with a complete response (CR). Study regimen considered successful if it exhibits a 3-year EFS rate greater than 60% and response rate no less than 90% with Grade III-IV infectious toxicity rate in induction no more than 33%.

Overall Survival defined: Time from date of treatment start until date of death due to any cause or last Follow-up.

Complete Response defined as: Bone Marrow blasts \</= 5%, Platelets \>/= 100 and an Absolute Neutrophil Count (ANC) \>/= 1000

To evaluate the prognostic significance of minimal residual disease (MRD) in bone marrow samples of participants who achieved a complete response (CR) at the end of induction (day 29) and at the end of consolidation (day 84) in this group of patients.

M.D. Anderson Cancer Center

Induction + Maintenance: Daunorubicin, Vincristine, PEG-asparaginase, Intrathecal Methotrexate, Cyclophosphamide, Cytarabine, Mercaptopurine, Doxorubicin, Thioguanine

Daunorubicin: Starting Dose 25 mg/m\^2 by vein weekly

Vincristine: Starting Dose 2 mg by vein weekly

PEG-asparaginase: Starting Dose 2000 International units/m2 by vein in week 1

Intrathecal Methotrexate: Starting Dose 12 mg on week 2 and week 5 injected into spinal fluid

Cyclophosphamide: Starting Dose 1g/m2 by vein in weeks 1 and 5

Cytarabine: 75 mg/m2 subcutaneous or by vein for four consecutive days on days 1-4 and days 8-11 of both months

Mercaptopurine: Starting Dose 60 mg/m2 by mouth on days 1-14 of each month

Methotrexate: Starting Dose at 100 mg/m2 by vein and escalating by 50 mg/m2/dose every 10

+/- 2 days for 5 doses to toxicity (e.g myelosuppression or mucositis grade 3

Doxorubicin: 25 mg/m2 by vein in weeks 1, 2 and 3

Thioguanine: 60 mg/m2 by mouth daily for two weeks

Augmented BFM Therapy

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Michael Andreeff MD./Professor

Of the 108 participants who had a complete response, 68 met the definition for 3 year EFS.

3-Year Event-Free Survival (EFS)

Overall Survival

Participants With a Complete Response (CR)

Participants with CR and MRD negative on Day 29

Participants with CR and MRD negative on day 84

Of the 108 participants who achieved a complete response (CR), 60 participants were MRD negative on day 29 and an additional 27 participants were MRD negative on day 84 for a total 87 MRD negative participants on day 84

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
DepoCyt Therapy in Patients With Neoplastic Meningitis From Lymphoma or a Solid Tumor	NCT00029523	Meningeal Neopl...	Intrathecal (in... Intrathecal met... Intrathecal cyt...	18 Years -	Pacira Pharmaceuticals, Inc
Bevacizumab With Etoposide and Cisplatin in Breast Cancer Patients With Brain and/or Leptomeningeal Metastasis	NCT01281696	Breast Neoplasm... Leptomeningeal ... Brain Metastase...	Bevacizumab, et... Intrathecal met...	18 Years - 75 Years	National Taiwan University Hospital
Modified MRCUKALLⅫ/ECOGE2993 Regimen for ALL	NCT02660762	Leukaemia,Lymph...	Vincristine Daunorubicin Pegaspargase Prednisone Intrathecal Met... Cyclophosphamid... Cytarabine 6-Mercaptopurin... Methotrexate Etoposide dexamethasone thioguanine intrathecal cyt...	18 Years - 35 Years	Sun Yat-sen University
Bevacizumab With Etoposide and Cisplatin in Breast Cancer Patients With Brain and/or Leptomeningeal Metastasis	NCT01281696	Breast Neoplasm... Leptomeningeal ... Brain Metastase...	Bevacizumab, et... Intrathecal met...	18 Years - 75 Years	National Taiwan University Hospital
Modified MRCUKALLⅫ/ECOGE2993 Regimen for ALL	NCT02660762	Leukaemia,Lymph...	Vincristine Daunorubicin Pegaspargase Prednisone Intrathecal Met... Cyclophosphamid... Cytarabine 6-Mercaptopurin... Methotrexate Etoposide dexamethasone thioguanine intrathecal cyt...	18 Years - 35 Years	Sun Yat-sen University
Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma	NCT00866749	Lymphoblastic L... Lymphoblastic L...	Daunorubicin Vincristine PEG-asparaginas... Intrathecal Met... Cyclophosphamid... Cytarabine Mercaptopurine Methotrexate Doxorubicin Thioguanine	12 Years - 40 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for intrathecal methotrexate