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Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma Clinical research trials and Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma healthcare trials occur in a lot of 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 generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma clinical trial. Test subjects typically receive the most effective healthcare possible for their Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma  Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
For Condition: stage 1 multiple myeloma,stage 2 multiple myeloma,refractory plasma cell neoplasm,stage 3 multiple myeloma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , H. Lee Moffitt Cancer Center and Research Institute
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have multiple myeloma.
Details: OBJECTIVES: I. Determine the toxicity and potential efficacy of intensive high dose chemotherapy consisting of melphalan, topotecan, and etoposide phosphate followed by autologous stem cell transplantation in patients with stage II or III multiple myeloma or stage I with evidence of progressive disease. II. Determine the maximum tolerated dose of topotecan in combination with melphalan and etoposide phosphate in this patient population. III. Determine response rates and time to treatment failure in these patients when treated with this regimen. IV. Determine the pharmacokinetic profiles of these drugs and investigate the pharmacodynamic relationships with respect to the efficacy and toxicity of this regimen in these patients. V. Determine whether the sequencing of this chemotherapy regimen is appropriate and optimal in these patients. PROTOCOL OUTLINE: This is a dose escalation study of topotecan. Patients are primed with cyclophosphamide IV over 2 hours for 2 days. Peripheral blood stem cells (PBSC) are collected. Approximately 4 weeks after PBSC collection, patients receive melphalan IV over 30 minutes and topotecan IV over 30 minutes on days -7 to -5. Etoposide phosphate IV is administered over 4 hours on days -4 and -3. PBSC are reinfused on day 0. Cohorts of 4-12 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 6 of 12 patients experience dose limiting toxicities. Patients are followed 2-3 times a week for approximately 1 month, then at 3, 6, and 12 months. PROJECTED ACCRUAL: A total of 34-60 patients will be accrued for this study within 24-36 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/69 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed multiple myeloma; Newly diagnosed, drug sensitive (i.e., greater than 50% response to standard chemotherapy), and poor prognostic indicators (e.g., Salmon-Durie stage III, serum beta-2-microglobulin greater than 3.0 ug/L, high proliferative fraction, or hypodiploidy) OR Relapsed after a response to standard chemotherapy OR Primary refractory disease - No active leptomeningeal involvement - History of prior CSF tumor involvement without symptoms or signs allowed provided CSF is now free of disease on lumbar puncture and MRI of brain shows no tumor involvement - No severe symptomatic CNS disease of any etiology --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior total dose of doxorubicin or daunorubicin greater than 450 mg/m2; No prior topotecan or any other topoisomerase I inhibitor, etoposide, etoposide phosphate, or teniposide - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Not specified - Other: No concurrent nitroglycerin preparations for angina pectoris; No concurrent antiarrhythmic drugs for major ventricular dysrhythmias --Patient Characteristics-- - Age: 15 to 69 - Performance status: ECOG 0-1 ECOG 3-4 secondary to bone pain or a potentially reversible disease related problem eligible at investigator's discretion - Life expectancy: At least 12 weeks - Hematopoietic: Not specified - Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT/SGPT no greater than 2.5 times upper limit of normal; No history of severe hepatic dysfunction - Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine at least 40 mL/min; No hemodialysis or peritoneal dialysis - Cardiovascular: No evidence of severe cardiac dysfunction; Ejection fraction at least 50% by MUGA scan; No major heart disease; Essential hypertension controlled with medications allowed - Pulmonary: DLCO at least 50% of normal; No symptomatic obstructive or restrictive pulmonary disease - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No psychosocial disorder that would preclude study compliance; No active infections; No uncontrolled insulin dependent diabetes mellitus; No uncompensated major thyroid or adrenal dysfunction; No other prior malignancy except for nonmelanoma skin cancer; HIV negative
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DanielSullivan, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Additional Information:
Study ID Numbers: CDR0000067746; NCI-G00-1749,MCC-11752,MCC-IRB-4983
Study Start Date: July 2000
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005792
Other Stage 1 Multiple Myeloma Studies:
1. O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma
2. Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma
3. PS-341 in Treating Patients With Refractory or Progressive Multiple Myeloma
4. Autologous T Cell Immunotherapy With or Without Fludarabine in Treating Patients With Relapsed or Refractory Multiple Myeloma
5. CCI-779 in Treating Patients With Relapsed or Refractory Multiple Myeloma
Related Studies:
Other stage 1 multiple myeloma Clinical Trials
Other Florida Clinical Trials
Other Tampa Clinical Trials
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
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