Symptoms and General Pathology

Wounds and Injuries

All Conditions

Neoplasms

Behaviors and Mental Disorders

Rare Diseases

Hyperthermia

Abdominal Neoplasms

Sarcoma

Fever

Rhabdomyosarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Myosarcoma

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Soft Tissue Sarcoma

Embryonal Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Participants receive complete surgical tumor resection with no gross residual disease, followed by hyperthermic intra-peritoneal chemotherapy (HIPEC) using Doxorubicin.

Participants receive debulking surgery followed by intra-operative radiation (IORT) in the form of brachytherapy to the gross residual pelvic tumor sites.

Participants have the option of returning for HIPEC 4 weeks (or more) after IORT, if active disease remains.

Resectable Intra-Abdominal/Pelvic Tumors Group: Participants receive peritonectomy, omentectomy, cytoreduction, (complete surgical tumor resection, no gross residual disease).

Unresectable Intra-Abdominal/Pelvic Tumors Group: Participants receive debulking surgery (90% resection) , with no more than 5mm thick residual implants, totaling no more than 2.5cm2 of residual tumor.

Abdominal Surgery

Dose Escalation: Heated Doxorubicin delivered by Hyperthermic Intraperitoneal Chemotherapy (HIPEC). After abdominal surgery two large bore catheters are placed in the peritoneal cavity through the incision. Starting dose of Doxorubicin is 15 mg/L of HIPEC perfusate.

Dose Expansion Starting Dose: MTD from Dose Escalation.

Standard dose brachytherapy delivered to the residual pelvic tumor sites.

Intra-Operative Radiation

Andrea Hayes-Jordan, MD

The goal of this clinical research study is to find the highest tolerable dose of heated doxorubicin that can be given to patients during surgery with abdominal tumors. The safety of this drug will also be studied.

Surgery and Study Drug Administration:

If participant is found to be eligible to take part in this study, surgery will be performed to try to remove as many tumors from participant's abdomen as possible. The surgery is not being performed specifically for this research study and would be performed as part of participant's standard of care treatment even if participant didn't take part in this study. Participant will be given a separate consent form to sign that explains the details and risks of the abdominal surgery in more detail.

During the surgery, if it is decided that all of the tumors can be removed, the abdomen will be closed with a plastic tube left in place. Then, the abdominal wash will begin. During the wash, a pump that is connected to the plastic tube pushes the heated doxorubicin into the abdomen and then pulls it out to recirculate the doxorubicin. The heated doxorubicin will be recirculated in and out of the abdomen over 90 minutes while the surgeon gently presses on the abdomen to help the doxorubicin reach all areas in the abdomen. The plastic tube that the heated doxorubicin will be pumped through will stay in place after the surgery to drain the extra fluid. These are the same plastic tubes that would be present even if participant did not agree to take part in this study.

There is a chance that the surgeon may decide during the surgery that the abdominal wash will not be performed, for example if the disease has spread to or attached to certain organs. If this occurs, as many of the tumors will be removed as possible, followed by brachytherapy and the implantation of radioactive seeds. To perform brachytherapy, straws loaded with radioactive seeds will be inserted into the abdominal area. The radiation will then take place in the operating room over about 20 minutes. The straws will be removed before ending the surgery. Participant may be able to return for the abdominal wash procedure 4 weeks after the seeds have been implanted.

Pharmacokinetic Testing:

During participant's surgery, extra blood (about ½ teaspoon each time) and fluid from the abdominal area will be collected for pharmacokinetic (PK) testing when participant begins to receive the first infusion of the heated doxorubicin then 30, 60 and 90 minutes after the infusion has started, and again 24 hours after receiving the heated doxorubicin. The blood and fluid from the abdominal area will be collected through already placed catheters, so no additional needle sticks will be required. PK testing measures the amount of study drug in the body at different time points.

Length of Study:

Participant will remain on study for up to 6 months. Participant will be taken off study if the disease gets worse.

If the study doctor learns that the disease has come back or gotten worse at the 6 month follow-up visit, participant may be eligible to have the operation with heated doxorubicin wash repeated. If participant is eligible to have the surgery repeated, participant's active participation on this study will end and then participant will be given a new consent form to sign in order to be re-enrolled back onto this study.

Study Visits:

On Days 1-5, 11, and 14, (Day 1 being the day after surgery):

* Blood (about 1 teaspoon) will be drawn for routine tests.
* Participant will have a physical exam.

Follow-Up Visits:

About 1, 3, and 6 months after the surgery is complete, participant will have a follow-up visit and the following tests and procedures will be performed:

* Participant will have a physical exam.
* Blood (about 1-3 teaspoons) will be drawn for routine tests.
* Participant will have an ECHO to check your heart function.

It is recommended that participant has follow-up visits at MD Anderson at 3 and 6 months after surgery. In addition to blood draws (about 1-3 teaspoons each time), participant will have an MRI, CT, or PET-CT scan to check the status of the disease. These 3 and 6 month visits after surgery may be performed at participant's local doctor's office and/or laboratory.

This is an investigational study. Doxorubicin is FDA-approved and commercially available. The use of a heated doxorubicin wash during abdominal surgery in patients with tumors is investigational. The study doctor can explain how the study drug is designed to work.

Up to 28 patients will take part in this study. All will be enrolled at MD Anderson.

Study of Doxorubicin and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Intraoperative Brachytherapy for Unresectable or Refractory Pelvic and Abdominal Rhabdomyosarcoma and Undifferentiated Sarcomas in Children

A Phase I Study of Doxorubicin and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Intraoperative Brachytherapy for Unresectable or Refractory Pelvic and Abdominal Rhabdomyosarcoma and Undifferentiated Sarcomas in Children

MTD defined as the highest dose in which 1 or fewer patients in 6 treated experience a dose limiting toxicity (DLT).

Hematologic DLT defined as Grade IV neutropenia, anemia, or thrombocytopenia per Common Toxicity Criteria. Non-hematologic DLT is any Grade III or IV non-hematologic toxicity excluding Grade III nausea or vomiting, Grade III hepatic toxicity which returns to Grade I within two weeks of the HIPEC, or before hospital discharge, or Grade III fever occurring after the HIPEC per Common Toxicity Criteria.

Disease progression defined by radio graphically visible nodules greater than 1.5 cm.

M.D. Anderson Cancer Center

Hematinics

Ifosfamide

Mitogens

Isophosphamide mustard

Darbepoetin alfa

Antineoplastic Agents, Alkylating

Alkylating Agents

Growth Factors = Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta)

Aranesp (darbepoetin alfa)

Neulasta (pegfilgrastim)

Adriamycin

Saroj Vadhan-Raj, M.D.

To determine the percentage of patients and number of cycles in which a packed red blood cell transfusion was administered due to anemia and in which antibiotics were administered due to neutropenic fever.

The use of hematopoietic growth factors have been shown to reduce neutropenic complications and red cell transfusion requirements associated with chemotherapy. This trial will study the combination of pegfilgrastim and darbepoetin alfa administered once per cycle of chemotherapy. Prior experience with growth factors in this setting provides historical data for comparison of safety and activity of these newer longer acting growth factors in reducing the incidence of febrile neutropenia requiring antibiotics and anemia requiring transfusions. The once dosing per cycle would simplify the patient management and would improve patient convenience and compliance.

Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide

A Pilot Study of Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta) in Patients With Sarcoma Receiving Adriamycin and Ifosfamide

Amgen

Skin and Connective Tissue Diseases

Adenocarcinoma

Breast Neoplasms

Breast Diseases

Skin Diseases

Antirheumatic Agents

Paclitaxel

Cyclophosphamide

Fluorouracil

Albumin-Bound Paclitaxel

Epirubicin

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antimetabolites

ARM 1: Participants receive Paclitaxel 80 mg/m2 by vein over 1 hour weekly for 12 doses of a 21 day cycle.

Participants on both arms receive FEC or FAC for 4 cycles (21 day cycle) at the preference of the treating physicians.

ARM 2: Participants receive Eribulin 1.4 mg/m2 by vein over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle).

Participants on both arms receive FEC or FAC for 4 cycles (21 day cycle) at the preference of the treating physicians.

80 mg/m2 by vein over 1 hour on Days 1, 8, and 15 of each 21-day cycle.

1.4 mg/m2 by vein over 2-5 minutes on Days 1 and 8 of each 21-day study cycle.

Eribulin

500 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.

5-Fluorouracil

100 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.

50 mg/m2 by vein on day 1, over 72 hour continuous infusion or intravenous bolus, for 4 cycles (21 day cycle) at preference of treating physicians.

Vicente Valero, MD

The goal of this clinical research study is to learn if and how well eribulin, given in combination with standard chemotherapy, can treat early-stage breast cancer compared to paclitaxel given in combination with standard chemotherapy. In this study, the standard chemotherapy being given is either 5-fluorouracil, epirubicin, and cyclophosphamide (called FEC) or 5-fluorouracil, doxorubicin, and cyclophosphamide (called FAC).

Eribulin is a changed version of the structure of a natural substance from a sea sponge. It is designed to block cells from dividing, which may cause cancer cells to die.

Paclitaxel is designed to block cancer cells from dividing, which may cause them to die.

5-fluorouracil is designed to block cancer cells from growing and dividing, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.

Epirubicin is designed to block the way cancer cells grow and divide, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.

Doxorubicin is designed to stop the growth of cancer cells, which may cause the cells to die.

Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and/or keep them from spreading throughout the body. This may cause the cancer cells to die.

Study Groups If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being assigned to either group.

If you are in Group 1, you will receive paclitaxel for 4 cycles. You also will be treated with FAC or FEC for 4 cycles. Your treating doctor will decide whether you will receive FEC or FAC.

If you are in Group 2, you will receive eribulin for 4 cycles. You will also be treated with FAC or FEC for 4 cycles. Your treating doctor will decide whether you will receive FEC or FAC.

Each cycle is 21 days.

Study Drug Administration for Group 1 You will receive paclitaxel by vein over 1 hour on Days 1, 8, and 15 of each 21-day study cycle.

Before the infusion, you will be given drugs by vein, to help decrease the risk of an allergic reaction.

If you have severe side effects, future treatments may be delayed, the dose may be decreased, or you may be taken off study.

Once you have received 4 cycles of paclitaxel, you will receive either FEC or FAC chemotherapy for 4 cycles. Your treating doctor will decide whether you will receive FEC or FAC.

Study Drug Administration for Group 2 You will receive eribulin by vein over 2-5 minutes on Days 1 and 8 of each 21-day study cycle.

Once you have received 4 cycles of eribulin, you will receive FEC or FAC chemotherapy for 4 cycles. Your treating doctor will decide whether you will receive FEC or FAC.

FEC or FAC Treatment After you have received 4 cycles of either paclitaxel or eribulin, you will receive FEC or FAC.

If you are given FEC chemotherapy, you will receive 5-Fluorouracil by vein over 15 minutes, epirubicin by vein over 30 minutes, and cyclophosphamide by vein over 30-60 minutes on Day 1 of every 21-day cycle.

If you are given FAC chemotherapy, you will receive 5-Fluorouracil by vein over 15 minutes, doxorubicin by vein over 15 minutes, and cyclophosphamide by vein over 30-60 minutes on Day 1 of 21-day cycle.

Before FEC or FAC chemotherapy, you will be given drugs by vein to help decrease the risk of allergic reaction. These drugs will include dexamethasone and zofran.

Study Visits During Paclitaxel or Eribulin On Day 1 of each cycle: If you have had these tests within 10 days before Day 1 of Cycle 1, they may not need to be repeated.

You will have a physical exam, including a measurement of your weight and vital signs.

You will be asked about any side effects you may be having and any drugs you may be taking.

Your performance status will be recorded. Blood (about 1-2 teaspoons) will be drawn for routine tests.

On Days 8 and 15 of Cycle 1-4, blood (about 1 teaspoon) will be drawn for routine tests.

At Week 12, you will have a core biopsy.

At the end of Cycle 4:

You will have an ultrasound of the breast to check the status of the disease. You will have an ECHO or MUGA scan. You will have a core biopsy and fine needle aspiration of the tumor. A small needle will be inserted into the tumor at the safest and easiest location to withdraw cancer cells. This will be used to learn which tumor markers may predict who may best respond to therapy.

Study Visits During FEC or FAC Chemotherapy

On Day 1 of every third week:

You will have a physical exam, including a measurement of your weight and vital signs.

You will be asked about any side effects you may be having and any drugs you may be taking.

Your performance status will be recorded. Blood (about 1-2 teaspoons) will be drawn for routine tests.

After you have finished FEC or FAC treatment, you may have surgery. At the end of the chemotherapy treatment, you will be referred to the breast surgeon to discuss surgery. There is an small possibility (less than 3%) that tumor has gotten worse during treatment, and additional chemotherapy may be necessary.

Length of Study You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

This is an investigational study. Paclitaxel, doxorubicin, epirubicin, and cyclophosphamide are FDA approved and commercially available for the treatment of breast cancer. Eribulin is FDA approved and commercially available to treat metastatic breast cancer in patients who have received at least 2 chemotherapy regimens for the treatment of metastatic disease. The use of eribulin with the FEC/FAC regimens is investigational for neoadjuvant treatment.

Eribulin will be provided at no cost to you while you are on this study. You and/or your insurance provider will be responsible for the cost of paclitaxel, doxorubicin, epirubicin, and cyclophosphamide.

Up to 162 patients will take part in this study. All will be enrolled at MD Anderson.

Neoadjuvant Study of Sequential Eribulin Followed by FAC Compared to Sequential Paclitaxel Followed by FEC in Early Stage Breast Cancer Not Overexpressing HER-2

A Randomized Phase II Neoadjuvant Study of Sequential Eribulin Followed by FAC/FEC-regimen Compared to Sequential Paclitaxel Followed by FAC/FEC-Regimen in Women With Early Stage Breast Cancer Not Overexpressing HER-2

Pathologic complete response (pCR) defined as complete absence of any viable invasive cancer cells in the resected breast and lymph nodes. Participants undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. Tumors removed by either lumpectomy with axillary dissection (i.e. breast conservation surgery) or modified radical mastectomy (i.e. mastectomy with axillary clearance). Surgical specimens (breast and axillary lymph node tissue) evaluated for pathological complete response.

Event free survival (EFS) the length of time after primary treatment for a cancer ends that the patient remains free of certain complications or events that the treatment was intended to prevent or delay.

Eisai Inc.

Only \>/= grade 3 serious adverse events are reported

Patients will receive Paclitaxel 80 mg/m2 IVPB over 1 hour weekly for 12 doses followed by FAC/FEC.

Paclitaxel Weekly for 12 Doses Followed by FAC/FEC

Patients will receive eribulin 1.4 mg/m2 IV infusion or per institutional guidelines over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle) followed by FAC/FEC.

Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC

Total

Age, Categorical

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Dr. Valero Vicente, Professor, Breast Medical Oncology

Pathologic Complete Response (pCR)

5 Year Event Free Survival (EFS)

Overall Survival (OS)

Overall Study

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma, Non-Hodgkin

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Lymphosarcoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Dermatologic Agents

Reproductive Control Agents

Micronutrients

Vitamins

Dexamethasone

Cytarabine

Methotrexate

Prednisone

Rituximab

Vincristine

Daunorubicin

Dexamethasone acetate

BB 1101

Pegaspargase

Mercaptopurine

Thioguanine

Asparaginase

Ofatumumab

Antineoplastic Agents, Immunological

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Antiviral Agents

HIV Protease Inhibitors

Protease Inhibitors

Folinic Acid

Folate

Vitamin B9

Participants receive the study drugs in Induction, Consolidation, and Maintenance Courses.

Participants initially receive intrathecal treatment using Cytarabine 100 mg on Day 1. Induction chemotherapy must begin within 3 days of the intrathecal Cytarabine dose.

Consolidation Therapy 1: Cytarabine 75 mg/m2 subcutaneously Days 1 - 4 and 8 - 11.

Consolidation Therapy 3B: Cytarabine 75 mg/m2 subcutaneously Days 1 - 4 and Days 8 - 11.

Induction Therapy: Daunorubicin 25 mg/m2 by vein weekly for 4 doses.

Induction Therapy: Vincristine 1.5 mg/m2 by vein weekly for 4 doses.

Consolidation Therapy 1: Vincristine 1.5 mg/m2 by vein Week 3 and Week 4.

Consolidation Therapy 2: Vincristine 1.5 mg/m2 by vein every 10 days for 5 doses.

Consolidation Therapy 3A: Vincristine 1.5 mg/m2 by vein weekly for 3 doses.

Consolidation Therapy 3B: Vincristine 1.5 mg/m2 by vein Weeks 3 and 4.

Maintenance Therapy (24 months): Vincristine 1.5 mg/m2 by vein every 28 days.

Induction Therapy: Prednisone 60 mg/m2/day by mouth for 28 days.

Induction Therapy: PEG asparaginase 2000 IU/m2 by vein on Day 4 of induction.

Consolidation Therapy 1: PEG-asparaginase 2000 IU/m2 by vein Week 3 and Week 7.

Consolidation Therapy 2: PEG-asparaginase 2000 IU/m2 by vein Weeks 1 and 4.

Consolidation Therapy 3A: PEG-asparaginase 2000 IU/m2 by vein in Week 1.

Consolidation Therapy 3B: PEG-asparaginase 2000 IU/m2 by vein Week 3.

PEG asparaginase

Induction Therapy: Ofatumumab 300 mg by injection or vein on Day 2 and Ofatumumab 2000 mg by injection or vein on Day 15.

Consolidation Therapy 1: Ofatumumab 2000 mg by injection or vein Week 1 and Week 5.

Consolidation Therapy 2: Ofatumumab 2000 mg by injection or vein Week 1 and Week 5.

Consolidation Therapy 3A: Ofatumumab 2000 mg by injection or vein Week 1 and Week 3.

Induction Therapy: If Ofatumumab not available, Rituximab 375 mg/m2 by vein on Day 1 and on Day 15.

Consolidation Therapy 1: If Ofatumumab not available, Rituximab 375 mg/m2 by vein Week 1 and Week 5.

Consolidation Therapy 2: If Ofatumumab not available, Rituximab 375 mg/m2 by vein Week 1 and Week 5.

Consolidation Therapy 3A: If Ofatumumab not available, Rituximab 375 mg/m2 by vein Week 1 and Week 3.

Induction Therapy: Intrathecal methotrexate 12 mg on Day 8 and Day 29.

Consolidation Therapy 1: Intrathecal methotrexate 12 mg Weekly, Weeks 1 - 4.

Consolidation Therapy 2: Methotrexate by vein every 10 days starting at 100 mg/m2 and increasing by 50 mg/m2 as tolerated. and Intrathecal methotrexate 12 mg Week 1.

Consolidation Therapy 3A: Intrathecal methotrexate 12 mg in Week 1.

Consolidation Therapy 3B: Intrathecal methotrexate 12 mg Week 1 and 2.

Maintenance Therapy (24 months): Methotrexate 20 mg/m2 by mouth weekly, hold on days of intrathecal methotrexate.

Maintenance Therapy (24 months): Intrathecal methotrexate 12 mg every 3 months for 4 doses.

Consolidation Therapy 1: Cyclophosphamide 1 gram/m2 by vein Week 1 and Week 5.

Consolidation Therapy 3B: Cyclophosphamide 1 gram/m2 by vein Week 1.

Consolidation Therapy 1: Mercaptopurine 60 mg/m2/day by mouth Days 1 - 14.

Maintenance Therapy (24 months): Mercaptopurine 75 mg/m2 by mouth nightly.

Consolidation Therapy 3A: Doxorubicin 25 mg/m2 by vein weekly for 3 doses.

Consolidation Therapy 3A: Dexamethasone 10 mg/m2 by mouth on Days 1 - 7 and Days 15 - 21.

Maintenance Therapy (24 months): Dexamethasone 6 mg/m2/day by mouth Days 1 - 5 every 28 days.

Consolidation Therapy 3B: Thioguanine 60 mg/m2/day by mouth for 14 days.

Michael E. Rytting, MD

The goal of this clinical research study is to learn if a chemotherapy combination called augmented Berlin-Frankfurt-Munster (BFM), when also combined with ofatumumab or rituximab, can help to control precursor-B ALL or LL in patients who are 12-30 years of age. The safety of these drug combinations will also be studied.

Augmented BFM is made up of daunorubicin, vincristine, prednisone, dexamethasone, PEG asparaginase, and methotrexate.

Study Drug Administration:

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.

You will then receive the study drugs in Induction, Consolidation, and Maintenance Courses. Induction Therapy is designed to remove the signs of leukemia that can be seen and to allow normal blood cells to be restored. This is called remission. Consolidation and Maintenance Therapies are designed to cause the disease to stay in remission.

The study drugs will be given the following ways:

* Daunorubicin by vein over about 30 minutes
* Vincristine by vein over 15-30 minutes
* PEG asparaginase by vein over 15-60 minutes
* Methotrexate either by mouth or as an injection into your spinal fluid (intrathecal), depending on the course. When given through the spinal fluid, cerebrospinal fluid (CSF) will be collected 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 each week until there is no disease present.
* Ofatumumab as an injection or by vein. If given by vein, the length of the infusion will depend on how well you tolerate the drug. If ofatumumab is not available, you will be given rituximab by vein over several (about 4-6) hours.
* Cyclophosphamide by vein over about 1 hour
* Cytarabine as an injection under the skin or by vein. If given by vein, the length of the infusion will depend on how well you tolerate the drug.
* Doxorubicin by vein. If given by vein, the length of the infusion will depend on how well you tolerate the drug.
* Prednisone, 6-Mercaptopurine, dexamethasone, and 6-Thioguanine are all taken by mouth

Within 3 days after you receive cytarabine, you will begin the Induction Course, which will last for 4 weeks. In the Induction Course, you will receive:

* Daunorubicin and vincristine on Days 1, 8, 15, and 22
* PEG asparaginase 1 time during Week 1
* Prednisone each day on Days 1-28.
* Intrathecal methotrexate at Weeks 2 and 5 during a spinal tap. If the is disease in your spinal fluid before starting the treatment, you will be given additional methotrexate doses each week until there is no disease present.
* Ofatumumab or rituximab on Days 2 and 15

Depending on how you respond to Induction, you may begin the Consolidation Courses 1-4 weeks after Induction.

You will then receive Consolidation Course 1. This course will last 8 weeks, and you will receive:

* Cyclophosphamide at Weeks 1 and 5
* Cytarabine on or around Days 1-4 and Days 8-11 of each 4-week cycle
* 6-Mercaptopurine on Days 1-14 of each 4-week cycle
* Vincristine at Weeks 3 and 4 of each 4-week cycle
* PEG Asparaginase at Weeks 3 and 7
* Intrathecal methotrexate weekly during Month 1 only
* Ofatumumab or rituximab at Weeks 1 and 5

You will then receive 2 courses of Consolidation Course 2. Each course will last about 7 weeks, and you will receive:

* Vincristine and methotrexate every 10 (+/- 2) days for up to 5 doses
* PEG Asparaginase at Weeks 1 and 4
* Intrathecal methotrexate at Weeks 1 and 5
* Ofatumumab or rituximab at Weeks 1 and 5

You will then receive Consolidation 3 (Part A). This course will last for 4 weeks, and you will receive:

* Vincristine and doxorubicin at Weeks 1, 2, and 3
* Dexamethasone on Days 1-7 and Days 15-21
* PEG asparaginase at Week 1
* Intrathecal methotrexate at Week 1
* Ofatumumab or rituximab on Weeks 1 and 3

You will then receive Consolidation 3 (Part B). This course will last for 4 weeks, and you will receive:

* Cyclophosphamide at Week 1
* Cytarabine for 4 days in a row during Weeks 1-2
* 6-Thioguanine every day for the first 2 weeks.
* Intrathecal methotrexate at Weeks 1 and 2
* Vincristin at Weeks 3 and 4
* PEG Asparaginase at Week 3

Once you finish Consolidation, you will then receive 24 months of Maintenance Therapy.

* Vincristine every month.
* Dexamethasone for 5 days every month.
* 6-Mercaptopurine 1 time a day
* Methotrexate by mouth every week.
* If you have ALL, you will also receive intrathecal methotrexate every 3 months for the first 12 months of maintenance.

Study Tests/Procedures:

Induction:

* Blood (about 3 teaspoons) will be drawn about 2 times each week during the Induction Period for routine tests.
* You will have a bone marrow aspirate or biopsy on Days 15 and 29 and then as needed to check the status of the disease.
* About 7 days after you receive your first dose of PEG asparaginase, blood (about 1 tablespoon) will be drawn to check the activity of the drug in your blood. If the drug does not seem to be working well, your dose may be changed.
* If you have LL and bone marrow was not found to be involved with the disease at screening, you will have a chest x-ray, CT scans, and positron emission tomography (PET) scans to measure the disease. These scans will be done after about 28 days of therapy.

Consolidation 1:

* Blood (about 3 teaspoons) will be drawn for routine tests about 2 times each week.
* You will have a spinal tap during each intrathecal methotrexate dose. The spinal fluid will be checked for leukemia cells.
* You will have a bone marrow aspiration at the end of Month 2 to check the status of the disease.

Consolidation 2:

* Blood (about 3 teaspoons) will be drawn every 2 weeks for routine tests.
* You will have a spinal tap during each intrathecal methotrexate doses. The spinal fluid will be checked for leukemia cells.

Consolidation 3 (Part A and B):

* Blood (about 3 teaspoons) will be drawn at least weekly for routine tests.
* You will have a spinal tap during each intrathecal methotrexate dose. The spinal fluid will be checked for leukemia cells.

Maintenance:

* You will have a spinal tap during each intrathecal methotrexate dose. The spinal fluid will be checked for leukemia cells.
* You will have a bone marrow aspiration at least every 3-6 months to check the status of the disease.

Length of Study:

You may remain on study for as long as the study doctor thinks it is in your best interest. If the disease does not appear to be improving after Induction, you will be taken off study. You may be taken off study if the disease gets worse or comes back during treatment, if intolerable side effects occur, if your doctor thinks it is in your best interest, or if you cannot follow the study instructions.

Follow-up Visits:

Your study doctor will inform you of your follow-up visit schedule in the clinic. At each follow-up visit there will be a physical exam and blood (about 1 tablespoon) will be drawn for routine tests. You will be followed-up for the next 3 years after your the last dose of your chemotherapy.

This is an investigational study. The chemotherapy drugs used in this study are all FDA approved and commercially available for the treatment of various types of leukemia. The use of ofatumumab/rituximab in this drug combination, as well as the drug combination's use in pediatric patients, is investigational.

Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.

Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Event free survival defined as the time from treatment to relapse of leukemia or death for any reason or lost to follow-up. Study regimen considered successful if it exhibits a 3-year EFS rate greater than 65% and response rate no less than 90% with Grade III-IV infectious toxicity rate in induction no more than 33%.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Doxorubicin and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Intraoperative Brachytherapy for Unresectable or Refractory Pelvic and Abdominal Rhabdomyosarcoma and Undifferentiated Sarcomas in Children	NCT03111069	Malignant Neopl... Rhabdomyosarcom... Rhabdomyosarcom...	Abdominal Surge... Doxorubicin Intra-Operative...	1 Year - 6 Years	M.D. Anderson Cancer Center
Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide	NCT00283621	Sarcoma	Aranesp (darbep... Neulasta (pegfi... Adriamycin Ifosfamide	18 Years - 65 Years	M.D. Anderson Cancer Center
Neoadjuvant Study of Sequential Eribulin Followed by FAC Compared to Sequential Paclitaxel Followed by FEC in Early Stage Breast Cancer Not Overexpressing HER-2	NCT01593020	Breast Cancer	Paclitaxel Eribulin 5-Fluorouracil Epirubicin Cyclophosphamid... Doxorubicin	18 Years -	M.D. Anderson Cancer Center
Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma	NCT02419469	Leukemia Precursor-B Acu... Lymphoblastic L... Lymphoma	Cytarabine Daunorubicin Vincristine Prednisone PEG asparaginas... Ofatumumab Rituximab Methotrexate Cyclophosphamid... Mercaptopurine Doxorubicin Dexamethasone a... Thioguanine	12 Years - 30 Years	M.D. Anderson Cancer Center
Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma	NCT02419469	Leukemia Precursor-B Acu... Lymphoblastic L... Lymphoma	Cytarabine Daunorubicin Vincristine Prednisone PEG asparaginas... Ofatumumab Rituximab Methotrexate Cyclophosphamid... Mercaptopurine Doxorubicin Dexamethasone a... Thioguanine	12 Years - 30 Years	M.D. Anderson Cancer Center

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