Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT00002905
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D016049', 'term': 'Didanosine'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D008942', 'term': 'Mitoxantrone'}, {'id': 'D011238', 'term': 'Prednimustine'}, {'id': 'D015215', 'term': 'Zidovudine'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D007288', 'term': 'Inosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'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': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D000880', 'term': 'Anthraquinones'}, {'id': 'D000095322', 'term': 'Anthrones'}, {'id': 'D000873', 'term': 'Anthracenes'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D002699', 'term': 'Chlorambucil'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '1995-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'lastUpdateSubmitDate': '2013-09-19', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-06-08', 'lastUpdatePostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-06-09', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['AIDS-related peripheral/systemic lymphoma'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': "RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.\n\nPURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with HIV-related non-Hodgkin's lymphoma that has relapsed or has not responded to chemotherapy.", 'detailedDescription': "OBJECTIVES: I. Evaluate the response rate and duration of response to etoposide, mitoxantrone, and prednimustine in patients with relapsed HIV-associated non-Hodgkin's lymphoma (NHL). II. Evaluate the response rate and duration of response to cyclophosphamide, doxorubicin, and etoposide in patients with refractory HIV-associated NHL. III. Assess the toxic effects of these regimens in these patients.\n\nOUTLINE: Patients with relapsed non-Hodgkin's lymphoma (NHL) receive oral etoposide and prednimustine on days 1-5 and intravenous mitoxantrone on day 1 every 3 weeks. Patients with refractory NHL receive cyclophosphamide, doxorubicin, and etoposide as a continuous infusion over 4 days every 4 weeks. All patients receive concomitant antiretroviral therapy with zidovudine or didanosine. G-CSF is given for hematologic support as indicated. All patients are evaluated for response after 2 courses of chemotherapy. Patients with a complete response (CR) receive 2 additional courses. Patients with a stable or partial response receive 2 additional courses and are re-evaluated; those with a CR receive 2 more courses, while those with a stable or partial response are treated off study at the physician's discretion. Patients with progressive disease are removed from study.\n\nPROJECTED ACCRUAL: 15-20 patients will be treated on each regimen."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS: Histologically proven non-Hodgkin's lymphoma at first presentation No documented CNS involvement (i.e., primary CNS or meningeal lymphoma) Positive serologic test for HIV antibodies required No opportunistic infection unless effectively treated Disease relapsed, refractory, or unresponsive to first-line chemotherapy No more than 1 prior combination chemotherapy regimen Chemotherapy consisted of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or a CHOP-like regimen, ACVBP, or other similar regimen\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: At least 1 month Hematopoietic: Not specified Hepatic: Bilirubin less than 5 times normal OR Transaminases less than 5 times normal Renal: Creatinine less than 2 mg/dL\n\nPRIOR CONCURRENT THERAPY: See Disease Characteristics"}, 'identificationModule': {'nctId': 'NCT00002905', 'briefTitle': "Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma", 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': "PROSPECTIVE NON-RANDOMIZED STUDY WITH CHEMOTHERAPY FOR RELAPSED OR REFRACTORY HIV-RELATED NON-HODGKIN'S LYMPHOMA: VMP REGIMEN FOR RELAPSED PATIENTS, CDE REGIMEN FOR REFRACTORY PATIENTS", 'orgStudyIdInfo': {'id': 'CDR0000065256'}, 'secondaryIdInfos': [{'id': 'ITA-GICAT-C-941202-3'}, {'id': 'EU-96059'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cyclophosphamide', 'type': 'DRUG'}, {'name': 'didanosine', 'type': 'DRUG'}, {'name': 'doxorubicin hydrochloride', 'type': 'DRUG'}, {'name': 'etoposide', 'type': 'DRUG'}, {'name': 'mitoxantrone hydrochloride', 'type': 'DRUG'}, {'name': 'prednimustine', 'type': 'DRUG'}, {'name': 'zidovudine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33081', 'city': 'Aviano', 'country': 'Italy', 'facility': 'Centro di Riferimento Oncologico - Aviano', 'geoPoint': {'lat': 46.07056, 'lon': 12.59472}}], 'overallOfficials': [{'name': 'Umberto Tirelli, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Centro di Riferimento Oncologico - Aviano'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro di Riferimento Oncologico - Aviano', 'class': 'OTHER'}}}}