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Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma Clinical research trials and Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma. Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma clinical trial. Test subjects typically receive the most expert healthcare available for their Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma  Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma
Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma
For Condition: stage 1 multiple myeloma,stage 3 multiple myeloma,stage 2 multiple myeloma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Fox Chase Cancer Center
Synopsis: 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. PURPOSE: Phase II trial to study the effectiveness of combining isotretinoin and dexamethasone in treating patients who have multiple myeloma.
Details: 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. PROTOCOL OUTLINE: 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. PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed multiple myeloma - Elevated monoclonal protein in serum and/or urine --Prior/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 --Patient 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RussellSchilder, Study Chair, Fox Chase Cancer Center
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301-1792
United States
Bon Secours-Holy Family Health System
Altoona, Pennsylvania, 16602
United States
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
United States
North Penn Hospital
Lansdale, Pennsylvania, 19446-1200
United States
Saint Mary Regional Center
Langhorne, Pennsylvania, 19047
United States
South Jersey Regional Cancer Center
Millville, New Jersey, 08332
United States
Pinnacle Health Hospitals
Harrisburg, Pennsylvania, 17105-8700
United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, 08060
United States
Kimball Medical Center
Lakewood, New Jersey, 08701
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Conemaugh Memorial Hospital
Johnstown, Pennsylvania, 15905
United States
Riverview Medical Center - Booker Cancer Center
Red Bank, New Jersey, 07701
United States
St. Francis Medical Center
Trenton, New Jersey, 08629
United States
Community Medical Center
Toms River, New Jersey, 08755
United States
Pottstown Memorial Regional Cancer Center
Pottstown, Pennsylvania, 19464
United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
United States
Southern Chester County Medical Center
West Grove, Pennsylvania, 19390
United States
Hunterdon Regional Cancer Center
Flemington, New Jersey, 08822
United States
Additional Information:
Study ID Numbers: CDR0000068772; NCI-G01-1985,FCCC-95043
Study Start Date: August 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021359
Other Stage 3 Multiple Myeloma Studies:
1. Chemotherapy and Peripheral Stem Cell Transplantation Followed By Immunotherapy in Treating Patients With Multiple Myeloma
2. Combination Chemotherapy and Thalidomide in Treating Patients With Stage I, Stage II, or Stage III Multiple Myeloma
3. Chemotherapy, Holmium Ho 166 DOTMP, and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
4. 2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors
5. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis
Related Studies:
Other stage 3 multiple myeloma Clinical Trials
Other Pennsylvania Clinical Trials
Other West Grove Clinical Trials
Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma
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