Chris Evert Children's Hospital
Pediatric Hematology/Oncology Clinical Trials

Pediatric Hematology/Oncology Clinical Trials

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Anti-Thymocyte Immune Globulin Solution for injection

What is this medicine?

ANTI-THYMOCYTE IMMUNE GLOBULIN (an tee THI mo cite im MUNE GLOB yoo lin) weakens the body's immune system. This medicine is used to treat kidney transplant rejection.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • fever

  • infection, especially viral infections

  • an unusual or allergic reaction to antithymocyte globulin, rabbits, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

This drug is given as an infusion into a vein. It is administered in a hospital or clinic by a specially trained health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

  • cancer chemotherapy

  • other medicine for immune system problems

  • steroid medicines like prednisone or cortisone

  • vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine. Visit your doctor for regular checks on your progress even after you complete your therapy.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick. Talk to your doctor before you get any vaccines.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • back or chest pain

  • breathing problems

  • fast, irregular heartbeat

  • feeling faint or lightheaded, falls

  • fever or chills, infection

  • mouth or throat sores or ulcers

  • pain at site where injected

  • pinpoint red spots on your skin

  • seizures

  • trouble passing urine or change in the amount of urine

  • unusual bleeding or bruising

  • unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • aches and pains

  • diarrhea

  • headache

  • nausea

  • night sweats

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.


Anti-Thymocyte Immune Globulin Solution for injection

What is this medicine?

ANTI-THYMOCYTE IMMUNE GLOBULIN (an tee THI mo cite im MUNE GLOB yoo lin) weakens the body's immune system. This medicine is used to prevent and to treat kidney transplant rejection. It is also used to treat aplastic anemia.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • fever

  • infection, especially viral infections

  • an unusual or allergic reaction to antithymocyte globulin, horses, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

This drug is given as an infusion into a vein. It is administered in a hospital or clinic by a specially trained health care professional.

Before your first dose of this medicine you need a skin test to check if you are allergic to this medicine.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

  • cancer chemotherapy

  • other medicine for immune system problems

  • steroid medicines like prednisone or cortisone

  • vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine. Visit your doctor for regular checks on your progress even after you complete your therapy.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick. Talk to your doctor before you get any vaccines.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • back or chest pain

  • breathing problems

  • fast, irregular heartbeat

  • feeling faint or lightheaded, falls

  • fever or chills, infection

  • mouth or throat sores or ulcers

  • pain at site where injected

  • pinpoint red spots on your skin

  • seizures

  • trouble passing urine or change in the amount of urine

  • unusual bleeding or bruising

  • unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • aches and pains

  • diarrhea

  • headache

  • nausea

  • night sweats

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.


Chris Evert Children's Hospital Clinical Trials Program focuses on having available clinical trials to improve cancer care by finding better ways to treat cancer and help pediatric cancer patients.

The decision to enroll in a clinical trial is voluntary and one that should be made with the close consultation of a physician.

Research Physicians

Dr. Rodriguez-Cortes

Hector Rodriguez-Cortes, MD
Principal Investigator

Dr. Roskos

Rudolph Roskos, MD
Investigator

Dr. Cambara

Alejandro Cambara, MD
Investigator

Research Office Staff

Claudia Diaz Pow Sang, BSN, RN, CCRP, Clinical Research Coordinator
Arlene McMillan, BSN, RN, OCN, MS, Clinical Research Nurse/Regulatory

Contact Information

For further information, please contact the Pediatric Hematology/Oncology Research Department:

  • Principal Investigator 954-355-4527
  • Pediatric Hematology Oncology Research Office at 954-355-5488 or 954-712-6406
  • or visit: www.clinicaltrials.gov

Clinical Trials List

Updated: June 2014

Leukemia
AALL0232: High Risk B-precursor Acute Lymphoblastic Leukemia (ALL)
Status: Closed to enrollment / Open for transfer only
AALL0331: Standard Risk B-precursor Acute Lymphoblastic Leukemia
Status: Closed to enrollment / Open for transfer only
AALL03B1: Classification of Acute Lymphoblastic Leukemia
Status: Closed to enrollment / Open for transfer only
AALL0433: Intensive Treatment for Intermediate-Risk Relapse of Childhood B-Precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies
Status: Closed to enrollment
AALL0434: Intensified Methotrexate, Nelarabine (Compound 506U78;IND #52611) and Augmented BFM Therapy for Children and Young Adults with Newly Diagnosed T-cell Acute Lymphoblastic Leukemia (ALL)
Status: Open to enrollment
AALL05B1: A Children's Oncology Group Protocol for Collecting and Banking Relapsed Acute Lymphoblastic Leukemia Research Specimens
Status: Open to enrollment
AALL07P1: A Phase II Pilot Trial of Bortezomib (PS-341, Velcade, IND# 58,443) in Combination with Intensive Re-Induction Therapy for Children with Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)
Status: Open to enrollment
AALL08B1: The Classification of Acute Lymphoblastic Leukemia
Status: Open to enrollment
AALL0932: Treatment of Patients with Newly Diagnosed Standard Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)
Status: Open to enrollment
AALL1131: A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Testing Clofarabine (IND# 73789, NSC# 606869) in the Very High Risk Stratum
Status: Open to enrollment
AAML0431: The Treatment of Down Syndrome Children with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Under the Age of 4 Years
Status: Closed to enrollment / Open for transfer only
AAML0531: A Phase III Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg®) Combined with Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults
Status: Closed to enrollment / Open for transfer only
AAML1031: A Phase III Randomized Trial for Patients with de novo AML using Bortezomib (IND# 58443, NSC# 681239) and Sorafenib (BAY 43-9006, IND#69896, NSC# 724772) for Patients with High Allelic Ratio FLT3/ITD
Status: Open to enrollment
9904: ALinC 17 Treatment for Patients with Low Risk Acute Lymphoblastic Leukemia - A Phase III Study
Status: Closed to enrollment / Open for transfer only

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Brain & Spine
ACNS02B3: A Children's Oncology Group Protocol for Collecting and Banking Pediatric Brain Tumor Research Specimens
Status: Open to enrollment
ACNS0331: A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy 18.00 Gy and Chemotherapy In Children with Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial
Status: Open to enrollment
ACNS0334: A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children < 36 Months Old with Intensive Induction Chemotherapy with Methotrexate Followed by Consolidation with Stem Cell Rescue vs. the Same Therapy Without Methotrexate
Status: Open to enrollment
ACNS0831: Phase III Randomized Trial of Post-Radiation chemotherapy in Patients with NewlyDiagnosed Ependymoma Ages 1 to 21 Years
Status: Open to enrollment

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Ewing Sarcoma
AEWS07B1: A Children's Oncology Group Protocol for Collecting and Banking Ewing Sarcoma Specimens
Status: Open to enrollment
AEWS07P1: A Pilot Study of Chemotherapy Intensification by adding Vincristine, Topotecan and Cyclophosphamide to Standard Chemotherapy Agents with an Interval Compression Schedule in Newly Diagnosed Patients with Localized Ewing Sarcoma Family of Tumors
Status: Closed to enrollment / Open for transfer only
AEWS1031: A Phase III Randomized Trial of Adding Vincristine-Topotecan-Cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-metastatic Ewing Sarcoma
Status: Open to enrollment

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Germ Cell
AGCT0132: A Phase III Study of Reduced Therapy in the Treatment of Children with Low and Intermediate Risk Extracranial Germ Cell Tumors Closed to enrollment
Status: Open for transfer only

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Liver
AHEP0731: Treatment of Children with All Stages of Hepatoblastoma
Status: Open to enrollment

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Lymphoma
AHOD0031: A Phase III Study of Dose-Intensive, Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents with Newly Diagnosed Intermediate Risk Hodgkin Disease
Status: Closed to enrollment / Open for transfer only
AHOD04B1: Hodgkin Disease Banking Study
Status: Open to enrollment

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Neuroblastoma
ANBL0032: Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue
Status: Open to enrollment
ANBL00B1: Neuroblastoma Biology Studies
Status: Open to enrollment
ANBL00P3: A Phase III randomized trial of Intravenous Gammaglobulin Therapy for Patients with Neuroblastoma Associated Opsoclonus-Myoclonus-Ataxia Syndrome Treated with Chemotherapy and Prednisone
Status: Closed to enrollment

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Osteosarcoma/Bone
AOST06B1: A Children's Oncology Group Protocol for Collecting and Banking Osteosarcoma Specimens
Status: Open to enrollment

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Renal/Kidney
AREN03B2: Renal Tumors Classification, Biology, and Banking Study
Status: Open to enrollment
AREN0532: Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor
Status: Closed to enrollment
AREN0534: Treatment for Patients with Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor
Status: Open to enrollment

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Rhabdomyosarcoma (Soft Tissue Sarcoma)
ARST0331: Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients with Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma
Status: Closed to enrollment / Open for transfer only
ARST0332: Risk-Based Treatment for Non-Rhabdomyosarcoma Soft Tissue Sarcomas in Patients Under 30 Years of Age
Status: Closed to enrollment / Open for transfer only
9902: A COG Soft Tissue Sarcoma Diagnosis, Biology and Banking Protocol
Status: Open to enrollment

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Other
ABTR01B1: A Children's Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors
Status: Open to enrollment
ACCL0933: A Randomized Open-Label Trial of Caspofungin versus Fluconazole to Prevent Invasive Fungal Infections in Children Undergoing Chemotherapy for Acute Myeloid Leukemia (AML)
Status: Open to enrollment
ACCRN07: Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN)
Status: Open to enrollment
ALTE05N1: Umbrella Long-term Follow-up Protocol
Status: Open to enrollment

Please call the Principal Investigator or Study coordinator with any questions or potential subjects.

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