Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-26 @ 1:44 PM
Study NCT ID:
NCT00021359
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
2001-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D015474', 'term': 'Isotretinoin'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-09', 'studyFirstSubmitDate': '2001-07-11', 'studyFirstSubmitQcDate': '2004-03-10', 'lastUpdatePostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-07', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage I multiple myeloma', 'stage II multiple myeloma', 'stage III multiple myeloma'], 'conditions': ['Multiple Myeloma and Plasma Cell Neoplasm']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with dexamethasone may be an effective treatment for multiple myeloma.\n\nPURPOSE: Phase II trial to study the effectiveness of combining isotretinoin and dexamethasone in treating patients who have multiple myeloma.', 'detailedDescription': 'OBJECTIVES: I. Determine the response rate and duration of response of patients with multiple myeloma treated with dexamethasone and isotretinoin. II. Determine the toxicity of this regimen in these patients. III. Correlate the changes in serum interleukin (IL)-6, IL-6R, and C-reactive and IL-6R expression on plasma cells in the bone marrow with response in patients treated with this regimen.\n\nOUTLINE: Patients receive oral dexamethasone on days 1-4, 9-12, and 17-20 and oral isotretinoin daily. Treatment repeats every 5 weeks for at least 2 courses in the absence of disease progression, insufficient response, or unacceptable toxicity. Patients achieving adequate response continue treatment for 2 courses after achieving a plateau of monoclonal protein, for a minimum of 6 courses total.\n\nPROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study within 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Histologically confirmed multiple myeloma Elevated monoclonal protein in serum and/or urine\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3\\* Platelet count at least 75,000/mm3\\* \\*Unless secondary to multiple myeloma involvement of the bone marrow Hepatic: Bilirubin less than 1.5 mg/dL Transaminase less than 2 times normal Renal: Creatinine less than 2.0 mg/dL No overt renal insufficiency Cardiovascular: No congestive heart failure No myocardial infarction within the past 6 months No significant arrhythmia or poorly controlled hypertension Pulmonary: No severe pulmonary disease Other: Triglycerides normal No other severe medical illness No active peptic ulcer disease No brittle insulin-dependent diabetes No severe depression or other psychiatric illness No active infection No history of severe ethanol or drug abuse Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior palliative radiotherapy allowed Surgery: At least 3 weeks since prior major surgery'}, 'identificationModule': {'nctId': 'NCT00021359', 'briefTitle': 'Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Fox Chase Cancer Center'}, 'officialTitle': 'A Phase II Trial of Dexamethasone and 13-cis-Retinoic Acid as First-Line Treatment for Multiple Myeloma', 'orgStudyIdInfo': {'id': 'CDR0000068772'}, 'secondaryIdInfos': [{'id': 'FCCC-95043', 'type': 'OTHER', 'domain': 'Fox Chase Cancer Center'}, {'id': 'NCI-G01-1985', 'type': 'OTHER_GRANT', 'domain': 'NCI'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'dexamethasone', 'type': 'DRUG'}, {'name': 'isotretinoin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08822', 'city': 'Flemington', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hunterdon Regional Cancer Center', 'geoPoint': {'lat': 40.51233, 'lon': -74.85933}}, {'zip': '08701', 'city': 'Lakewood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Kimball Medical Center', 'geoPoint': {'lat': 40.09789, 'lon': -74.21764}}, {'zip': '08332', 'city': 'Millville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'South Jersey Regional Cancer Center', 'geoPoint': {'lat': 39.40206, 'lon': -75.03934}}, {'zip': '08060', 'city': 'Mount Holly', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County', 'geoPoint': {'lat': 39.99289, 'lon': -74.78766}}, {'zip': '07701', 'city': 'Red Bank', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Riverview Medical Center - Booker Cancer Center', 'geoPoint': {'lat': 40.34705, 'lon': -74.06431}}, {'zip': '08755', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Community Medical Center', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '08629', 'city': 'Trenton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'St. Francis Medical Center', 'geoPoint': {'lat': 40.21705, 'lon': -74.74294}}, {'zip': '16602', 'city': 'Altoona', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Bon Secours-Holy Family Health System', 'geoPoint': {'lat': 40.51868, 'lon': -78.39474}}, {'zip': '19026', 'city': 'Drexel Hill', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Delaware County Memorial Hospital', 'geoPoint': {'lat': 39.94706, 'lon': -75.29213}}, {'zip': '17105-8700', 'city': 'Harrisburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pinnacle Health Hospitals', 'geoPoint': {'lat': 40.2737, 'lon': -76.88442}}, {'zip': '15905', 'city': 'Johnstown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Conemaugh Memorial Hospital', 'geoPoint': {'lat': 40.32674, 'lon': -78.92197}}, {'zip': '19047', 'city': 'Langhorne', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Saint Mary Regional Center', 'geoPoint': {'lat': 40.17455, 'lon': -74.92267}}, {'zip': '19446-1200', 'city': 'Lansdale', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'North Penn Hospital', 'geoPoint': {'lat': 40.2415, 'lon': -75.28379}}, {'zip': '19301-1792', 'city': 'Paoli', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Paoli Memorial Hospital', 'geoPoint': {'lat': 40.04205, 'lon': -75.47631}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19464', 'city': 'Pottstown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pottstown Memorial Regional Cancer Center', 'geoPoint': {'lat': 40.24537, 'lon': -75.64963}}, {'zip': '19612-6052', 'city': 'Reading', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Reading Hospital and Medical Center', 'geoPoint': {'lat': 40.33565, 'lon': -75.92687}}, {'zip': '19390', 'city': 'West Grove', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Southern Chester County Medical Center', 'geoPoint': {'lat': 39.82205, 'lon': -75.82744}}], 'overallOfficials': [{'name': 'Russell J. Schilder, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fox Chase Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fox Chase Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}