Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2025-12-25 @ 4:09 PM
Study NCT ID:
NCT00187057
Status:
COMPLETED
Last Update Posted:
2015-08-27
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study for Treatment of Cancer in Children With Ataxia-telangiectasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001260', 'term': 'Ataxia Telangiectasia'}, {'id': 'D001259', 'term': 'Ataxia'}], 'ancestors': [{'id': 'D020754', 'term': 'Spinocerebellar Ataxias'}, {'id': 'D002524', 'term': 'Cerebellar Ataxia'}, {'id': 'D002526', 'term': 'Cerebellar Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020752', 'term': 'Neurocutaneous Syndromes'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D013684', 'term': 'Telangiectasis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D000081207', 'term': 'Primary Immunodeficiency Diseases'}, {'id': 'D049914', 'term': 'DNA Repair-Deficiency Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014747', 'term': 'Vinblastine'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D001215', 'term': 'Asparaginase'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D011344', 'term': 'Procarbazine'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D000581', 'term': 'Amidohydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D013438', 'term': 'Sulfhydryl Compounds'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-26', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2015-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the feasibility of delivering modified intensive chemotherapy to children with A-T who present with cancer.', 'timeFrame': 'The completion of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ataxia', 'alphafetoprotein'], 'conditions': ['Ataxia-Telangiectasia']}, 'referencesModule': {'references': [{'pmid': '16772123', 'type': 'BACKGROUND', 'citation': 'Sandlund JT, Kastan MB, Kennedy W, Behm F, Entrekin E, Pui CH, Kalwinsky DT, Raimondi SC. A subtle t(3;8) results in plausible juxtaposition of MYC and BCL6 in a child with Burkitt lymphoma/leukemia and ataxia-telangiectasia. Cancer Genet Cytogenet. 2006 Jul 1;168(1):69-72. doi: 10.1016/j.cancergencyto.2005.12.013.'}], 'seeAlsoLinks': [{'url': 'http://www.stjude.org', 'label': "St. Jude Children's Research Hospital"}]}, 'descriptionModule': {'briefSummary': 'This is a pilot/feasibility study designed to investigate the feasibility of treating children with Ataxia-Telangiectasia (A-T) and cancer with regimens nearly as intense as non-A-T patients with cancer would receive.', 'detailedDescription': 'Approximately 10-30% of A-T patients will develop a malignancy during their lifetime. The vast majority of these cancers are of lymphoid origin. There is no consensus regarding the optimal strategy for treating children with A-T who develop hematopoietic malignancies. Historically, many of these children have been treated with therapy that is much less intensive than the conventional approach for non-A-T patients with similar malignancies during the corresponding treatment era. Although these less intensive approaches may have stemmed from perceptions that these children would not tolerate intensive therapy, there is in fact no data to suggest that these children cannot tolerate intensive therapy. However, it is clear that children with A-T require a modification in certain components of intensive therapy.\n\nTo provide children with A-T and either ALL or malignant lymphoma the best chance for a cure, we propose to use modern therapeutic strategies with minimal modifications which address the unique toxicity profile encountered in treating children with A-T.\n\nSecondary objectives include:\n\n* To clinically and biologically characterize the malignancies occurring in children with A-T (usually malignant lymphoma or ALL). This will include in vitro drug sensitivity screening.\n* To study chemotherapy-induced DNA damage in children with A-T.\n\nDetailed Description of Treatment Plan:\n\n* Acute Lymphoblastic Leukemia (ALL) Low Risk:\n\nInduction:\n\nPrednisone 40 mg/m2/day PO days 1-28\n\nVinblastine 6 mg/m2/dose IV day 8\n\nVincristine 1.5 mg/m2/dose days 1, 15\n\nDaunomycin 20 mg/m2/week IV days 1,15\n\nAsparaginase 10,000 U/m2/dose IM days 2, 4, 6, 8, 10, 12\n\nVP-16 225 mg/m2/dose Days 22, 25, 29\n\nAra-C 300 mg/m2/dose Days 22, 25, 29\n\nAll patients will receive CNS therapy with triple intrathecal therapy on days 1, 22 and 43 of induction treatment, dose age adjusted.\n\nConsolidation:\n\nMethotrexate 2 mg/m2 IV day 43 and 50 and mercaptopurine 75 mg/m2 days 43-56.\n\nContinuation therapy (120 weeks):\n\nWeek:\n\n1. 6-MP + MTX\n2. 6-MP + MTX\n3. 6-MP + MTX\n4. Dex + VCR\n5. 6-MP + MTX\n6. 6-MP + MTX\n7. 6-MP + HDMTX\n8. Dex + VCR\n9. 6-MP + MTX\n10. 6-MP + MTX\n11. 6-MP + MTX\n12. Dex + VCR\n13. 6-MP + MTX\n14. 6-MP + MTX\n15. 6-MP + HDMTX\n\nThis sequence will be repeated through week 52 after which 6-MP + MTX will be given weekly to complete 120 weeks. IT MHA (MTX, hydrocortisone, Ara-C) on weeks 1, 2, 7, and 15 and then every 4-8 weeks depending on CNS status.\n\nDosages, Schedules and Routes:\n\n6-MP 75 mg/m2 PO; daily x 7\n\nMTX 40 mg/m2 IM or IV; q (every) week;\n\nDex 6 mg/m2 PO; in 3 divided doses daily x 7\n\nVCR 1.5 mg/m2 IV (max. 2.0 mg)\n\nHDMTX 2 g/m2 IV over 2 hours, every 8 weeks\n\nReinduction:\n\nReinduction therapy (weeks 16-21). Reinduction therapy (same as initial induction treatment minus dose 2 and 3 of VP16 +ara-C and minus day 22 intrathecal therapy) will be given after bone marrow examination on week 15 confirms complete remission.\n\n* Acute Lymphoblastic Leukemia (ALL) - High Risk\n\nInduction:\n\nPrednisone 40 mg/m2/day PO) divided in 3 doses days 1-28\n\nVinblastine 6 mg/m2/dose IV day 8\n\nVincristine 1.5 mg/m2/dose days 1, 15\n\nDaunomycin 20 mg/m2/week IV days 1, 15\n\nAsparaginase 10,000 U/m2/dose IM days 2, 4, 6, 8, 10, 12, (15, 17, 19)\n\nVP16 225 mg/m2/dose days 22, 25, 29\n\nAra-C 300 mg/m2/dose days 22,25,29\n\nAll patients will receive triple IT therapy on days 1, 22 and 43 of induction with additional IT therapy on days 8 and 15 if CNS leukemia (CNS 2 or CNS 3) is present at diagnosis. If required, for patients with CNS 2 and 3 at diagnosis, IT therapy will continue until 2 consecutive CSF studies are normal (i.e., days 29 and 36).\n\nConsolidation:\n\nHDMTX 2 mg/m2 IV day 43 and 50\n\n6 MP 75 mg/m2 PO days 43-56\n\nContinuation Therapy (120 weeks):\n\nWeek:\n\n1. Dex + VCR\n2. VP-16 + CTX\n3. 6-MP + MTX\n4. MTX + Ara-C\n5. Dex + VCR\n6. VP-16 + CTX\n7. 6-MP + HDMTX\n8. 6-MP + MTX\n9. Dex + VCR\n10. VP-16 + CTX\n11. 6-MP + MTX\n12. MTX + Ara-C\n13. Dex + VCR\n14. VP-16 + CTX\n15. 6-MP + HDMTX\n\nThese sequences will be repeated through week 52, after which 6MP/MTX will be given weekly to complete 120 weeks.\n\nIT MHA (MTX, hydrocortisone, Ara-C) on weeks 1, 2, 7, and 15 and then every 4-8 weeks depending on CNS status and risk status.\n\nDosages, Schedules and Routes:\n\nVP 16 225 mg/m2 IV once a week\n\nCyclophosphamide 300 mg/m2 IV (with MESNA) once a week in addition to the 6 hour IV hydration\n\n6-MP 75 mg/m2 PO; daily x 7\n\nMTX 40 mg/m2 IM or IV once a week\n\nAra-C 300 mg/m2 IV push; once a week\n\nDex 8 mg/m2/day PO; in 3 divided doses daily x 7\n\nVCR 1.5 mg/m2 IV push (max. 2.0 mg)\n\nHDMTX 2 g/m2 IV over 2 hours; every 8 weeks x 7\n\n* B-Cell Non-Hodgkins Lymphoma\n\nOverview - the chemotherapy regimen used varies with grouping based on extent of disease\n\nGroup A\n\nInduction (COPAD x 2 cycles):\n\nCyclophosphamide 500 mg/m2/day (divided every 12 hour) IV (with MESNA) Day 1, 2, 3\n\nVincristine 2.0 mg/m2 IV Day 1\n\nVinblastine 6 mg/m2 IV Day 6\n\nPrednisone 60 mg/m2/day (bid) PO Day 1-5\n\nAdriamycin 50 mg/m2 (over 6 hrs) IV Day 1\n\nG-CSF 5 mcg/kg/day until count recovery.\n\nGroup B\n\nCOP Induction:\n\nCyclophosphamide 300 mg/m2 IV (divided every 12 hours) IV (with MESNA) Day 1\n\nVincristine 1.0 mg/m2 IV Day 1\n\nPrednisone 60 mg/m2/day (divided bid) PO days 1-7\n\nCNS Therapy Intrathecal Day 1 - dose age adjusted\n\nCOPAD-M3 Induction x 2 cycles:\n\nVinblastine 6 mg/m2 IV Day 1\n\nHD MTX 3 mg/m2 IV over 3 hours Day 1 with leucovorin rescue\n\nCNS Therapy intrathecal each age adjusted Day 2, 6\n\nCyclophosphamide 500 mg/m2/day (second course 1 mg/m2/day) IV (with MESNA) Day 2, 3, 4\n\nAdriamycin 50 mg/m2 IV Day 2\n\nPrednisone 60 mg/m2 (divided bid) PO Day 1-5\n\nG-CSF 5 mcg/kg/day until count recovery\n\nCYM Consolidation x 2 cycles:\n\nHD MTX 3 mg/m2 IV over 3 hours Day 1 with leucovorin rescue\n\nAra-C 100 mg/m2/day CI/IV (x 5 days) Day 2-6\n\nCNS Therapy intrathecal each age adjusted Day 2 and 7\n\nMaintenance:\n\nPrednisone 60 mg/m2/day (divided bid) PO Day 1-5\n\nHDMTX 3 mg/m2 IV over 3 hours Day 1 with leucovorin rescue\n\nCNS Therapy intrathecal each age adjusted Day 2\n\nCyclophosphamide 500 mg/m2/day IV (with MESNA) Day 2, 3\n\nAdriamycin 50 mg/m2 IV Day 3\n\nVincristine 2 mg/m2 IV Day 1\n\nG-CSF 5 mcg/kg/day until count recovery\n\n* Limited Stage Non-Hodgkins Lymphoma\n\nInduction:\n\nVincristine 2 mg/m2 IV days 1, 22 (maximum dose 2 mg)\n\nVinblastine 6 mg/m2 IV, day 8\n\nPrednisone 40 mg/m2/day in 3 divided doses x 28 days\n\nAdriamycin 30 mg/m2/day IV over one hour days 1 and 22\n\nCyclophosphamide 750 mg/m2/day IV days 1 and 22\n\nTriple IT chemotherapy for participants with head and neck primary tumors on days 1, 8, 22. Each dose age adjusted.\n\nConsolidation - start day 43:\n\nAdriamycin 30 mg/m2 by IV\n\nCyclophosphamide 750 mg/m2\n\nPrednisone 40 mg/m2 in 3 divided doses x 5 days\n\nVincristine 2.0 mg/m2 (max. 2.0 mg) by IV\n\nTriple IT chemotherapy for head and neck primaries on days 43 and 64.\n\nMaintenance:\n\nMaintenance chemotherapy will be administered only to patients with lymphoblastic lymphoma and will consist of 24 weeks of chemotherapy with oral daily 6-MP and weekly oral methotrexate (and TIT every 6 weeks for patients with head and neck primaries) after induction/consolidation.\n\n* Hodgkins Disease\n\nParticipants with favorable disease will receive VAMP chemotherapy:\n\nVAMP chemotherapy doses and schedule:\n\nVinblastine 6 mg/m2, IV day 1, 15 (maximum dosage: 10 mg)\n\nAdriamycin 25 mg/m2, IV day 1, 15\n\nMethotrexate 20 mg/m2, IV day 1, 15\n\nPrednisone 40 mg/m2 PO day 1-14 divided into 3 daily doses\n\nRepeat cycle every 28 days, total number of cycles = 6 (NO RADIATION THERAPY)\n\nParticipants with unfavorable disease will receive VAMP and COP:\n\nVAMP chemotherapy doses (cycles 1, 3, 5, 7)\n\nVinblastine 6 mg/m2 IV day 1, 15\n\nAdriamycin 25 mg/m2 IV day 1,15\n\nMethotrexate 20 mg/m2 IV day 1, 15\n\nPrednisone 40 mg/m2 (divided into 3 daily doses) PO day 1-14\n\nCOP chemotherapy doses (cycles 2, 4, 6, 8)\n\nCyclophosphamide 600 mg/m2 IV (with MESNA) day 1, 8\n\nVincristine 1.4 mg/m2 IV day 1,8 (max dose 2 mg)\n\nProcarbazine 100 mg/m2 PO day 1-14\n\n(NO RADIATION THERAPY)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient must have a diagnosis of Ataxia-Telangiectasia (A-T).\n* Patient must have a diagnosis of either acute lymphoblastic leukemia (ALL) or lymphoma (non-Hodgkin lymphoma or Hodgkin's disease).\n* Patients with other malignancies (solid tumors, rare malignancies, or relapsed hematopoietic malignancies) will be eligible for the biologic studies of this protocol; they will receive best clinical management chemotherapy.\n* Patients do not have to be previously untreated. If prior chemotherapy has already started (up through induction), therapy will be continued according to protocol at a clinically appropriate time point.\n\nExclusion Criteria:\n\n* Patients who do not have a diagnosis of Ataxia Telangiectasia (A-T)."}, 'identificationModule': {'nctId': 'NCT00187057', 'briefTitle': 'Study for Treatment of Cancer in Children With Ataxia-telangiectasia', 'organization': {'class': 'OTHER', 'fullName': "St. Jude Children's Research Hospital"}, 'officialTitle': 'Pilot Study I for Treatment of Cancer in Children With Ataxia-Telangiectasia', 'orgStudyIdInfo': {'id': 'AT-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Acute Lymphoblastic Leukemia (ALL) Low Risk', 'interventionNames': ['Drug: vinblastine, vincristine, prednisone, daunorubicin', 'Drug: doxorubicin, methotrexate, cyclophosphamide, L-asparaginase', 'Drug: etoposide, cytarabine, mercaptopurine', 'Drug: dexamethasone, procarbazine', 'Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy']}, {'type': 'OTHER', 'label': '2', 'description': 'Acute Lymphoblastic Leukemia (ALL) - High Risk', 'interventionNames': ['Drug: vinblastine, vincristine, prednisone, daunorubicin', 'Drug: doxorubicin, methotrexate, cyclophosphamide, L-asparaginase', 'Drug: etoposide, cytarabine, mercaptopurine', 'Drug: dexamethasone, procarbazine', 'Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy']}, {'type': 'OTHER', 'label': '3A', 'description': 'B-Cell Non-Hodgkins Lymphoma (Group A)', 'interventionNames': ['Drug: vinblastine, vincristine, prednisone, daunorubicin', 'Drug: doxorubicin, methotrexate, cyclophosphamide, L-asparaginase', 'Drug: etoposide, cytarabine, mercaptopurine', 'Drug: dexamethasone, procarbazine', 'Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy']}, {'type': 'OTHER', 'label': '3B', 'description': 'B-Cell Non-Hodgkins Lymphoma (Group B)', 'interventionNames': ['Drug: vinblastine, vincristine, prednisone, daunorubicin', 'Drug: doxorubicin, methotrexate, cyclophosphamide, L-asparaginase', 'Drug: etoposide, cytarabine, mercaptopurine', 'Drug: dexamethasone, procarbazine', 'Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy']}, {'type': 'OTHER', 'label': '4', 'description': 'Hodgkins Disease', 'interventionNames': ['Drug: vinblastine, vincristine, prednisone, daunorubicin', 'Drug: doxorubicin, methotrexate, cyclophosphamide, L-asparaginase', 'Drug: etoposide, cytarabine, mercaptopurine', 'Drug: dexamethasone, procarbazine', 'Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy']}], 'interventions': [{'name': 'vinblastine, vincristine, prednisone, daunorubicin', 'type': 'DRUG', 'description': 'See Detailed Description section for details of treatment interventions.', 'armGroupLabels': ['1', '2', '3A', '3B', '4']}, {'name': 'doxorubicin, methotrexate, cyclophosphamide, L-asparaginase', 'type': 'DRUG', 'description': 'See Detailed Description section for details of treatment interventions.', 'armGroupLabels': ['1', '2', '3A', '3B', '4']}, {'name': 'etoposide, cytarabine, mercaptopurine', 'type': 'DRUG', 'description': 'See Detailed Description section for details of treatment interventions.', 'armGroupLabels': ['1', '2', '3A', '3B', '4']}, {'name': 'dexamethasone, procarbazine', 'type': 'DRUG', 'description': 'See Detailed Description section for details of treatment interventions.', 'armGroupLabels': ['1', '2', '3A', '3B', '4']}, {'name': 'chemotherapy, intrathecal chemotherapy, steroid therapy', 'type': 'PROCEDURE', 'description': 'See Detailed Description section for details of treatment interventions.', 'armGroupLabels': ['1', '2', '3A', '3B', '4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'John T. Sandlund, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Jude Children's Research Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Jude Children's Research Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}