Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-01-01 @ 10:54 PM
Study NCT ID:
NCT00003268
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D007948', 'term': 'Leukemia, Monocytic, Acute'}, {'id': 'D004915', 'term': 'Leukemia, Erythroblastic, Acute'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D015479', 'term': 'Leukemia, Myelomonocytic, Acute'}, {'id': 'D007947', 'term': 'Leukemia, Megakaryoblastic, Acute'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004999', 'term': 'Amifostine'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D015255', 'term': 'Idarubicin'}], 'ancestors': [{'id': 'D063086', 'term': 'Organothiophosphates'}, {'id': 'D010755', 'term': 'Organophosphates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009946', 'term': 'Organothiophosphorus Compounds'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'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': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-10', 'completionDateStruct': {'date': '2003-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-01', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['untreated adult acute myeloid leukemia', 'adult acute monoblastic leukemia and acute monocytic leukemia (M5)', 'adult acute erythroid leukemia (M6)', 'adult acute myeloblastic leukemia without maturation (M1)', 'adult acute myeloblastic leukemia with maturation (M2)', 'adult acute myelomonocytic leukemia (M4)', 'adult acute megakaryoblastic leukemia (M7)', 'drug/agent toxicity by tissue/organ', 'adult acute minimally differentiated myeloid leukemia (M0)'], 'conditions': ['Drug/Agent Toxicity by Tissue/Organ', 'Leukemia']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy.\n\nPURPOSE: Phase I trial to study the effectiveness of amifostine in treating patients with newly diagnosed acute myeloid leukemia who are receiving idarubicin plus cytarabine.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine whether amifostine provides systemic protection against the nonhematologic side effects of idarubicin (IDR) during induction therapy of acute myeloid leukemia (AML), allowing the dose of idarubicin to be escalated.\n* Determine the maximum tolerated dose of idarubicin when amifostine is used as a chemotherapy protectant.\n* Determine the incidence and severity of dose limiting hypotension in patients receiving amifostine and the ability to offset this side effect with vasoconstrictive agents.\n* Determine whether any additional side effects of amifostine are dose limiting in patients with AML treated with IDR and cytarabine (ARA-C).\n* Monitor the frequency of alopecia, mucositis, diarrhea, and septicemia involving enteric pathogens in these patients.\n* Determine the requirement for intravenous hyperalimentation in patients receiving amifostine, IDR, and ARA-C.\n\nOUTLINE: This is a dose escalation study of idarubicin (IDR).\n\nPatients receive amifostine IV over 15 minutes, followed 15-30 minutes later by chemotherapy. Idarubicin IV is administered over 15 minutes on days 1-3. Cytarabine is administered by continuous infusion on days 1-7. Patients may receive 1 additional course of treatment, if necessary.\n\nCohorts of 3-6 patients each are treated at each dose level of idarubicin. Dose escalation is discontinued when 2 or more patients experience dose limiting toxicity.\n\nPatients are followed at 3 months.\n\nPROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Newly diagnosed acute myeloid leukemia (AML)\n\n * M0-M2, M4-M7\n * Histologically proven by bone marrow aspirate and biopsy (requirement may be waived for patients with overt leukemia in the peripheral blood)\n * M3 (acute promyelocytic leukemia) patients excluded unless already treated with trans retinoic acid\n* Evaluable disease\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Karnofsky 60-100%\n* ECOG 0-2\n\nLife expectancy:\n\n* At least 3 months\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* SGOT/SGPT no greater than 2.5 times upper limit of normal\n\nRenal:\n\n* Creatinine no greater than 2.0 mg/dL\n\nCardiovascular:\n\n* Ejection fraction at least 50%\n* Must be able to stop taking antihypertensive medication 24 hours prior to cytarabine administration\n\nOther:\n\n* No preexisting severe organ dysfunction\n* No history of underlying medical or psychiatric illness that may impair the patient's ability to participate in the study\n* Not pregnant or nursing\n* Effective contraception required of fertile patients\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* See Disease Characteristics\n* No prior cytotoxic therapy for AML\n* No prior amifostine\n* At least 1 month since chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* At least 1 month since radiotherapy\n\nSurgery:\n\n* Not specified"}, 'identificationModule': {'nctId': 'NCT00003268', 'briefTitle': 'Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I Study of Cytosine Arabinoside, Idarubicin, and Amifostine as Induction Therapy for Patients With Newly Diagnosed Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'TJUH-980407'}, 'secondaryIdInfos': [{'id': 'CDR0000066164', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'ALZA-97-040-ii'}, {'id': 'NCI-V98-1395'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'amifostine trihydrate', 'type': 'DRUG'}, {'name': 'cytarabine', 'type': 'DRUG'}, {'name': 'idarubicin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107-5541', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Kimmel Cancer Center of Thomas Jefferson University - Philadelphia', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Neal Flomenberg, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sidney Kimmel Cancer Center at Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Cancer Center at Thomas Jefferson University', 'class': 'OTHER'}}}}