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Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma Clinical research trials and Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma. Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma clinical trial. Human subjects often obtain the finest healthcare possible for their Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma  Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma
Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma
For Condition: stage 2 multiple myeloma,refractory plasma cell neoplasm,stage 3 multiple myeloma
Status: Recruiting
Sponsor(s): Cell Therapeutics , National Cancer Institute (NCI)
Synopsis: 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. PURPOSE: Phase II trial to study the effectiveness of combining arsenic trioxide and dexamethasone in treating patients who have recurrent or refractorystage II or stage III multiple myeloma.
Details: OBJECTIVES: - Determine the response rate of patients with recurrent or refractory stage II or III multiple myeloma treated with arsenic trioxide and dexamethasone. - Determine the rates of overall and relapse-free survival in patients treated with this regimen. - Determine the safety profile of this treatment regimen in these patients. OUTLINE: Patients receive arsenic trioxide IV daily for 5 days during the first week only and then 2 days a week thereafter. Patients also receive IV or oral dexamethasone on days 1-4 every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Disease assessments are conducted every 4 weeks. Patients achieving complete response (CR) receive 2 additional courses of therapy after initial determination of CR. Final assessments are conducted 4 weeks after the last study treatment and then annually thereafter. PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of stage II or III multiple myeloma - Refractory myeloma defined as progressive disease (more than 25% increase in M protein or in radiographic findings of nonsecretory myeloma) despite up to 3 courses of prior cytotoxic chemotherapy - No more than 3 prior cytotoxic regimens - No more than 1 prior high-dose cytotoxic regimen with stem cell transplantation - History of disease progression after prior steroid antimyeloma therapy - No smoldering myeloma - Measurable disease based on presence of serum and urine M protein and/or measurable plasmacytoma PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - Karnofsky 70-100% Life expectancy: - At least 3 months Hematopoietic: - Absolute granulocyte count greater than 1,200/mm^3* - Platelet count greater than 75,000/mm^3* - Hemoglobin greater than 10 g/dL* NOTE: *Unless due to multiple myeloma Hepatic: - Bilirubin no greater than 2 times upper limit of normal (ULN) - SGOT and SGPT no greater than 2 times ULN Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - Absolute QT interval less than 460 msec in the presence of normal potassium and magnesium levels - No significant underlying cardiac dysfunction - No conduction defects - No unstable angina - No congestive heart failure - No New York Heart Association class II-IV cardiac disease - No myocardial infarction within the past 6 months Other: - No preexisting grade 2 or greater neurotoxicity/neuropathy - No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer - No uncontrolled diabetes mellitus - No active serious infection uncontrolled by antibiotics - No history of grand mal seizures (other than infantile febrile seizures) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - See Chemotherapy - At least 28 days since prior biologic therapy Chemotherapy: - See Disease Characteristics - At least 28 days since prior cytotoxic chemotherapy, including high-dose cytotoxic regimen with stem cell transplantation - No other concurrent cytotoxic chemotherapy Endocrine therapy: - See Disease Characteristics Radiotherapy: - At least 28 days since prior radiotherapy except for focal radiation for symptom control Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ScottStromatt, Study Chair, Cell Therapeutics
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Raymond Comenzo 212-639-8086
Texas Cancer Care *Recruiting*
Ft. Worth, Texas, 76104
United States
Recruiting H. Mandell 817-759-7000
Mountain States Tumor Institute - Boise *Recruiting*
Meridian, Idaho, 83642
United States
Recruiting Theodore Walters 208-706-5651
Highlands Oncology Group - Springdale *Recruiting*
Springdale, Arkansas, 72764
United States
Recruiting Joseph Beck 501-751-2100
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Leonard Heffner 404-778-4189
St. Joseph Hospital Regional Cancer Center - Orange *Recruiting*
Orange, California, 92868-3849
United States
Recruiting Leonard Sender 714-771-8921
Rocky Mountain Cancer Centers - Midtown *Recruiting*
Denver, Colorado, 80218
United States
Recruiting Jeffrey Matous 303-285-5087
Pasco Pinellas Cancer Center - Tarpon Springs *Recruiting*
Tarpon Springs, Florida, 34689
United States
Recruiting Julio Hajdenberg 727-849-6690
Arizona Clinical Research Center *Recruiting*
Tucson, Arizona, 85712
United States
Recruiting Raymond Taetle 520-290-2510
Stockton Hematology Oncology Medical Group *Recruiting*
Stockton, California, 95204
United States
Recruiting Aminder Mehdi 209-466-2626
Additional Information:
Study ID Numbers: CDR0000068646; MSKCC-01012,NCI-G01-1951,CTI-1060
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017069
Other Refractory Plasma Cell Neoplasm Studies:
1. Combination Chemotherapy Following GM-CSF in Treating Patients With Multiple Myeloma
2. Stem Cell Transplantation in Treating Patients With Previously-Treated Multiple Myeloma
3. Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon alfa in Treating Patients With Advanced Multiple Myeloma
4. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
5. Combination Chemotherapy With or Without Thalidomide in Treating Patients With Refractory Multiple Myeloma
Related Studies:
Other refractory plasma cell neoplasm Clinical Trials
Other Georgia Clinical Trials
Other Atlanta Clinical Trials
Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma
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