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Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma Clinical research trials and Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma. Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma clinical trial. Subjects frequently get the best healthcare possible for their Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma  Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma
Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma
For Condition: refractory plasma cell neoplasm
Status: Recruiting
Sponsor(s): Sylvester Cancer Center , 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. Vitamin C may increase the effectiveness of arsenic trioxide by making cancer cells more sensitive to the drug. PURPOSE: Phase I/II trial to determine the effectiveness of arsenic trioxide plus vitamin C in treating patients who have recurrent or refractorymultiple myeloma.
Details: OBJECTIVES: - Determine the maximum tolerated dose of arsenic trioxide when administered with ascorbic acid in patients with recurrent or refractory multiple myeloma. - Determine the therapeutic efficacy of this treatment combination in these patients. - Determine the expression of MDR and Bcl-xL genes and the intracellular levels of GSH in these patients before and after this treatment regimen and assess whether these measures have prognostic value. OUTLINE: This is a multicenter, dose-escalation study of arsenic trioxide. - Patients receive arsenic trioxide IV over 1-4 hours and ascorbic acid IV over 5-10 minutes on days 1-5 weekly for 5 weeks. Treatment continues every 7 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of arsenic trioxide until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. - Phase II: Patients receive the MTD of arsenic trioxide with ascorbic acid as outlined above. Patients are followed monthly for up to 5 years. PROJECTED ACCRUAL: A total of 31-43 patients (6-18 for phase I and 16-25 for phase II) will be accrued for this study within 2.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed multiple myeloma - M-protein by serum protein electrophoresis or urine protein electrophoresis - Quantitative determination of immunoglobulin - Bone marrow biopsy and aspirate with a plasma cell count greater than 10% - Refractory or chemoresistant disease defined as failure to respond (less than 50% reduction in M protein level) or progression within 2 months after receiving at least 2 chemotherapy regimens including: - Alkylating based regimen (melphalan) in combination with steroids (prednisone) or other chemotherapy regimens (e.g., vincristine, bleomycin, melphalan, cyclophosphamide, and prednisone or vincristine, carmustine, doxorubicin, and prednisone) - Vincristine, doxorubicin, and dexamethasone (VAD) regimen - Pulse therapy with high dose steroids alone - High dose alkylating agent and autologous stem cell transplantation - Allogeneic bone marrow transplantation - Plateau phase defined as M protein in the serum or urine for more than 6 weeks despite response to prior therapy - Must have received at least 2 of the chemotherapy regimens listed above - Recurrent disease defined as progression more than 2 months after initial therapy and failure to respond (less than 50% reduction or progression in M protein levels) to 1 chemotherapy regimen listed above or other salvage regimens (e.g., high-dose cyclophosphamide or topotecan) - Must have received VAD or other chemotherapy regimen including vincristine and doxorubicin as prior therapy - Should be considered for autologous or allogenic transplantation - Prior local radiotherapy allowed PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - WBC at least 2,000/mm^3* - Platelet count at least 50,000/mm^3* NOTE: *Unless attributable to bone marrow infiltration by multiple myeloma Hepatic: - Bilirubin less than 3 mg/dL - Transaminases less than 2.5 times upper limit of normal (ULN) Renal: - Creatinine less than 1.5 times ULN OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No cardiac arrhythmias including recurrent supraventricular arrhythmia, any type of sustained ventricular arrhythmia, or conduction block (atrioventricular block grade II or III, left bundle branch block) - Ejection fraction at least 30% - No uncontrolled ischemic heart disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception during and for 4 months after study - HIV negative - No grade 3 or higher neurological disorder, including seizure disorders - No underlying medical condition that would preclude study - No other active malignancy except adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics Chemotherapy: - See Disease Characteristics - At least 2 weeks since prior chemotherapy Endocrine therapy: - See Disease Characteristics - Concurrent steroid treatment allowed except for primary treatment of myeloma Radiotherapy: - See Disease Characteristics - Concurrent local radiotherapy for pain or symptom control allowed provided the pain or symptom is not related to disease progression Surgery: - Not specified Other: - No other concurrent ascorbic acid supplements - No other concurrent investigational drug or therapy - Concurrent bisphosphonates allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KelvinLee, Study Chair, Sylvester Cancer Center
Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center *Recruiting*
Miami, Florida, 33140
United States
Recruiting Ruth Ratzan 305-535-3300
Cedars Medical Center *Recruiting*
Miami, Florida, 33136
United States
Recruiting Jonathan Cohen 305-325-5950
University of Miami Sylvester Cancer Center *Recruiting*
Miami, Florida, 33136
United States
Recruiting Hugo Fernandez 305-243-6558
Baptist Hospital of Miami *Recruiting*
Miami, Florida, 33176-2197
United States
Recruiting Michael Troner 305-959-2141
Additional Information:
Study ID Numbers: CDR0000068033; NCI-43,SCCC-20010,SCCC-NCI-43
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006021
Other Refractory Plasma Cell Neoplasm Studies:
1. Melphalan, Peripheral Stem Cell Transplantation, and Radiation Therapy in Treating Patients With Multiple Myeloma
2. Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma
3. Combination Chemotherapy With or Without Thalidomide in Treating Patients With Refractory Multiple Myeloma
4. Beta Alethine in Treating Patients With Myeloma
5. Bortezomib and Flavopiridol in Treating Patients With Recurrent or Refractory Indolent B-Cell Neoplasms
Related Studies:
Other refractory plasma cell neoplasm Clinical Trials
Other Florida Clinical Trials
Other Miami Clinical Trials
Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma
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