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CCI-779 in Treating Patients With Relapsed or Refractory Multiple Myeloma Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about CCI-779 in Treating Patients With Relapsed or Refractory Multiple Myeloma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. CCI-779 in Treating Patients With Relapsed or Refractory Multiple Myeloma Clinical research trials and CCI-779 in Treating Patients With Relapsed or Refractory Multiple Myeloma medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as CCI-779 in Treating Patients With Relapsed or Refractory Multiple Myeloma. CCI-779 in Treating Patients With Relapsed or Refractory Multiple Myeloma Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a CCI-779 in Treating Patients With Relapsed or Refractory Multiple Myeloma clinical trial. Participants frequently get the best healthcare available for their CCI-779 in Treating Patients With Relapsed or Refractory Multiple Myeloma condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > CCI-779 in Treating Patients With Relapsed or Refractory Multiple Myeloma  CCI-779 in Treating Patients With Relapsed or Refractory Multiple Myeloma
CCI-779 in Treating Patients With Relapsed or Refractory Multiple Myeloma
For Condition: refractory plasma cell neoplasm,stage 2 multiple myeloma,stage 1 multiple myeloma,stage 3 multiple myeloma
Status: Recruiting
Sponsor(s): Arthur G. James Cancer Hospital & Richard J. Solove Research Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as CCI-779 work in different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of CCI-779 in treating patients who have relapsed or refractorymultiple myeloma.
Details: OBJECTIVES: Primary - Determine the overall response rate in patients with relapsed or refractory multiple myeloma treated with CCI-779. Secondary - Determine the progression-free survival of patients treated with this drug. - Determine the toxicity of this drug in these patients. - Determine the presence of PTEN mutation in patients treated with this drug. - Correlate the pharmacokinetics of this drug with response in these patients. - Correlate the pharmacodynamic effects of this drug with response in these patients. OUTLINE: This is an open-label study. Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 16-25 patients will be accrued for this study within 8-12.5 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of multiple myeloma (MM) - Salmon-Durie stage IIA or IIIA OR progressive stage IA disease - Meets at least 1 major AND 1 minor criterion OR at least 3 minor criteria - The following are considered major criteria: - Plasmacytoma on tissue biopsy - Bone marrow plasmacytosis with 30% plasma cells - Monoclonal globulin spike on serum protein electrophoresis exceeding 3.5 g/dL for immunoglobulin (Ig) G peaks or 2.0 g/dL for IgA peaks OR the presence of Bence-Jones protein of 1 g/24 hour-urine collection - The following are considered minor criteria: - Bone marrow plasmacytosis 10-29% - Monoclonal globulin spike present, but less than the levels defined for a major criterion - Lytic bone lesion - Decrease in normal IgM < 50 mg/dL, IgA < 100 mg/dL, or IgG < 600 mg/dL - No non-secretory MM (absent serum or urinary M-protein) - Failed at least 1 prior systemic therapy* (e.g., chemotherapy, high-dose corticosteroids, thalidomide, or bortezomib) for the treatment of MM NOTE: *Patients who receive only radiotherapy or bisphosphonates are not eligible - No solitary plasmacytoma PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - More than 6 months Hematopoietic - Absolute neutrophil count > 1,200/mm^3 - Platelet count > 75,000/mm^3 Hepatic - AST and ALT 2.5 times upper limit of normal (ULN) - Bilirubin 1.5 times ULN Renal - Creatinine 1.5 times ULN Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Fasting cholesterol 350 mg/dL - Triglycerides 400 mg/dL - No other concurrent uncontrolled illness - No active or ongoing infection requiring oral or IV antibiotics - No prior allergic reaction to compounds of similar chemical or biological composition to CCI-779 - No other prior or concurrent malignancy or myelodysplasia except for the following: - Basal cell or squamous cell skin cancer - Carcinoma in situ of the cervix - Localized cancer treated with surgery only with no evidence of disease for > 5 years - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - See Chemotherapy - More than 4 weeks since prior thalidomide and recovered Chemotherapy - See Disease Characteristics - Prior high-dose chemotherapy and stem cell transplantation allowed - More than 4 weeks since prior chemotherapy and recovered Endocrine therapy - See Disease Characteristics - More than 4 weeks since prior high-dose corticosteroids and recovered Radiotherapy - See Disease Characteristics Other - More than 4 weeks since prior bortezomib and recovered - More than 4 weeks since other prior anti-myeloma systemic therapy and recovered - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent investigational agents - No other concurrent anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SherifFarag, Study Chair, Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting Sherif Farag 614-293-7527
Additional Information:
Study ID Numbers: CDR0000355767; OSU-2003C0090,NCI-6186,OSU-0347
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079456
Other Stage 1 Multiple Myeloma Studies:
1. Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma, or Multiple Myeloma
2. Beta Alethine in Treating Patients With Myeloma
3. Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
4. High-Dose Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Amyloidosis
5. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Related Studies:
Other stage 1 multiple myeloma Clinical Trials
Other Ohio Clinical Trials
Other Columbus Clinical Trials
CCI-779 in Treating Patients With Relapsed or Refractory Multiple Myeloma
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