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Pixantrone, Cytarabine, Methylprednisolone, and Cisplatin in Treating Patients With Aggressive Non-Hodgkin's Lymphoma in First Relapse Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Pixantrone, Cytarabine, Methylprednisolone, and Cisplatin in Treating Patients With Aggressive Non-Hodgkin's Lymphoma in First Relapse conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Pixantrone, Cytarabine, Methylprednisolone, and Cisplatin in Treating Patients With Aggressive Non-Hodgkin's Lymphoma in First Relapse Clinical research trials and Pixantrone, Cytarabine, Methylprednisolone, and Cisplatin in Treating Patients With Aggressive Non-Hodgkin's Lymphoma in First Relapse healthcare trials happen in many 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 drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Pixantrone, Cytarabine, Methylprednisolone, and Cisplatin in Treating Patients With Aggressive Non-Hodgkin's Lymphoma in First Relapse. Pixantrone, Cytarabine, Methylprednisolone, and Cisplatin in Treating Patients With Aggressive Non-Hodgkin's Lymphoma in First Relapse Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Pixantrone, Cytarabine, Methylprednisolone, and Cisplatin in Treating Patients With Aggressive Non-Hodgkin's Lymphoma in First Relapse clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Pixantrone, Cytarabine, Methylprednisolone, and Cisplatin in Treating Patients With Aggressive Non-Hodgkin's Lymphoma in First Relapse condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Pixantrone, Cytarabine, Methylprednisolone, and Cisplatin in Treating Patients With Aggressive Non-Hodgkin's Lymphoma in First Relapse  Pixantrone, Cytarabine, Methylprednisolone, and Cisplatin in Treating Patients With Aggressive Non-Hodgkin's Lymphoma in First Relapse
Pixantrone, Cytarabine, Methylprednisolone, and Cisplatin in Treating Patients With Aggressive Non-Hodgkin's Lymphoma in First Relapse
For Condition: recurrent adult Burkitt's lymphoma,recurrent grade 3 follicular lymphoma,recurrent adult diffuse large cell lymphoma,recurrent adult diffuse mixed cell lymphoma,anaplastic large cell lymphoma,recurrent adult immunoblastic large cell lymphoma
Status: Recruiting
Sponsor(s): Theradex ,
Synopsis: RATIONALE: Drugs used in chemotherapy, such as pixantrone, cytarabine, methylprednisolone, and cisplatin, work in 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 combination chemotherapy in treating patients who have relapsedaggressivenon-Hodgkin's lymphoma.
Details: OBJECTIVES: - Determine the antitumor activity of pixantrone, cytarabine, methylprednisolone, and cisplatin in patients with aggressive non-Hodgkin's lymphoma in first relapse. - Determine the safety and tolerability of this regimen in these patients. - Determine the validity and safety of this regimen as a mobilization regimen before high-dose chemotherapy with stem cell support in these patients. OUTLINE: This is an open-label, multicenter study. - Patients receive pixantrone IV over 1 hour on day 1; cisplatin IV over 30 minutes on days 1-4; methylprednisolone IV over 15-30 minutes on days 1-5; and cytarabine IV over 2 hours on day 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After 2 courses of salvage therapy, patients are re-evaluated and treated as follows: - Complete response (CR) or partial response (PR): Patients with a CR or PR who are suitable candidates for autologous stem cell transplantation (ASCT) proceed to mobilization therapy, high-dose chemotherapy, and ASCT. Patients with a CR or PR who are unsuitable candidates for ASCT continue to receive salvage therapy for up to 6 courses in the absence of disease progression or unacceptable toxicity. - Stable disease: Patients with stable disease continue to receive salvage therapy for up to 6 courses. Patients who have a CR or PR after 3-4 courses of salvage therapy and who are suitable candidates for ASCT proceed to mobilization therapy, high-dose chemotherapy, and ASCT off study at the investigator’s discretion. - Patients receive rituximab* IV on days 1 and 7; pixantrone IV over 1 hour on day 2; cisplatin IV over 30 minutes on days 2-5; cytarabine IV over 2 hours on day 6; and methylprednisolone IV over 15-30 minutes on days 2-6. Patients also receive filgrastim (G-CSF) subcutaneously once daily beginning on day 7 and continuing until blood counts recover. Patients receive 1 or more courses of mobilization therapy during which stem cells are harvested. Patients then proceed to high-dose chemotherapy and subsequent re-infusion of harvested stem cells. NOTE: *If this mobilization regimen is used, patients with T-cell lymphoma do not receive rituximab - High-dose chemotherapy and ASCT: Patients receive high-dose chemotherapy and ASCT per institutional standard practice. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 75 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: - Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) - Any stage, with or without B symptoms - The following subtypes are eligible: - Diffuse large cell (B and T cell types) - Anaplastic large cell - Diffuse mixed cell - Immunoblastic large cell - Follicular large cell - Transformed follicular NHL - Diffuse aggressive not otherwise classified - Burkitt-like lymphoma - Bone marrow positive or negative - At least 1 measurable lesion - Patients with bone marrow as the only site of disease are eligible without a measurable lesion - No more than 1 episode of progressive disease, occurring after a response (complete response [CR], complete response unconfirmed [CR - ], or partial response [PR]) to prior chemotherapy* NOTE: *Patients with less than a CR, CRu, or PR and no progression, but who are good candidates for high-dose chemotherapy with stem cell support may be eligible (will be decided on an individual basis) - No chemotherapy-refractory disease, defined as follows: - Stable or progressive disease documented at restaging immediately after the completion of induction therapy - No lymphoblastic lymphoma, or mantle cell lymphoma PATIENT CHARACTERISTICS: Age - 18 and over Performance status - WHO 0-1 Life expectancy - At least 3 months Hematopoietic - Neutrophil count at least 1,500/mm^3* - Platelet count at least 100,000/mm^3* NOTE: *Lower values may be accepted if clearly due to bone marrow involvement by lymphoma Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN)* - AST or ALT no greater than 2.0 times ULN* - Alkaline phosphatase no greater than 2.0 times ULN* - No history or clinical symptoms of hepatitis B or hepatitis C virus - Patients with seropositivity due to prior vaccination for hepatitis B are eligible NOTE: *Higher values may be accepted if clearly due to liver involvement by lymphoma Renal - Creatinine no greater than 1.5 mg/dL Cardiovascular - LVEF at least 50% by MUGA - No clinically significant cardiovascular abnormalities - No New York Heart Association grade II-IV cardiovascular disease - No myocardial infarction within the past 6 months - No severe cardiac arrhythmia - No uncontrolled hypertension Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study participation - HIV negative - No clinically significant neurological abnormalities - No condition that would preclude study safety or interfere with study results - No concurrent serious uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy - Prior rituximab immediately after the first chemotherapy regimen allowed Chemotherapy - See Disease Characteristics - See Biologic therapy - At least 6 months since prior anthracycline therapy (e.g., cyclophosphamide, doxorubicin, vincristine, and prednisone [CHOP]) - More than 2 years since prior fludarabine - More than 2 years since prior nitrosoureas - More than 1 year since prior platinum-based chemotherapy or cytarabine, unless a CR or CR_u was achieved - No prior cumulative dose of cisplatin greater than 600 mg/m^2 - No prior single or cumulative dose of doxorubicin greater than 450 mg/m^2 Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to the whole pelvis - No prior radioimmunotherapy Surgery - More than 4 weeks since prior major thoracic and/or abdominal surgery - At least 1 week since prior minor surgery Other - Recovered from prior therapy - Alopecia allowed - Grade 1 peripheral neuropathy allowed - More than 30 days since prior participation in another investigational drug study - No other concurrent investigational drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JulieVose, Study Chair, University of Nebraska
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5055
United States
Recruiting Brenda Cooper 216-844-3213
Hematology-Oncology Associates of Illinois *Recruiting*
Chicago, Illinois, 60611-2998
United States
Recruiting Stephanie Williams 312-664-5400
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting David Rizzieri 919-668-1000
Baylor University Medical Center *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Joseph Fay 214-820-2610
UNMC Eppley Cancer Center at the University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 68198-7680
United States
Recruiting Julie Vose 402-559-3848
USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles, California, 90033-0804
United States
Recruiting Alexandra Levine 323-865-3913
Cancer Care Associates-West *Recruiting*
Oklahoma City, Oklahoma, 73112-4414
United States
Recruiting Romeo Mandanas 405-943-9988
Hospital Auxilio Mutuo *Recruiting*
Hato Rey, , 00918
Puerto Rico
Recruiting Fernando Cabanillas 787-771-7935
Rocky Mountain Cancer Centers - Midtown *Recruiting*
Denver, Colorado, 80218
United States
Recruiting Robert Rifkin 303-388-4876
North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Steven Allen 516-562-8958
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Ann LaCasce 617-632-5959
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Brad Pohlman 216-445-6070
Fairfax Northern Virginia Hematology Oncology, P.C. *Recruiting*
Fairfax, Virginia, 22031
United States
Recruiting Roy Beveridge 703-280-5390
Providence Cancer Center at Providence Portland Medical Center *Recruiting*
Portland, Oregon, 97213
United States
Recruiting Stacy Lewis 503-215-6315
Arizona Oncology Associates - Craycroft Road Offices *Recruiting*
Tucson, Arizona, 85712-2254
United States
Recruiting Yusuf Ahmad 520-324-2497
Delaware Clinical & Laboratory Physicians *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Frank Beardell 302-737-7700
Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033-0850
United States
Recruiting W. Ehmann 717-531-8677
Rocky Mountain Cancer Centers *Recruiting*
Colorado Springs, Colorado, 80933-7148
United States
Recruiting Paul DeCarolis 719-577-2555
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010
United States
Recruiting Leslie Popplewell 626-359-8111 ext. 62405
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Luis Fayad 713-792-2860
Piedmont Hematology-Oncology Associates *Recruiting*
Winston Salem, North Carolina, 27103
United States
Recruiting Hugh Wallace 336-277-8800
Massachusetts General Hospital Cancer Center *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Karen Ballen 617-724-1124
Louisiana State University Health Sciences Center - Shreveport *Recruiting*
Shreveport, Louisiana, 71130-3932
United States
Recruiting Jonathan Glass 318-675-4756
University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Teresa Gentile 315-464-8240
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226-3596
United States
Recruiting David Vesole 414-805-4626
Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington, Kentucky, 40536-0084
United States
Recruiting Dianna Howard 859-323-1385
Pasco, Hernando Oncology Associates, P.A. *Recruiting*
New Port Richey, Florida, 34652
United States
Recruiting Kapisthalam Kumar 727-842-2795
Cancer Centers of the Carolinas - Eastside *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Gary Spitzer 864-370-1393
Gabrail Cancer Center - Canton Office *Recruiting*
Canton, Ohio, 44718
United States
Recruiting Nashat Gabrail 330-492-3345
Additional Information:
Study ID Numbers: CDR0000316466; THERADEX-AZA-II-02,NOVUSPHARMA-AZA-II-02,CWRU-NOVU-1403,SUNY-HSC-4849
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069966
Other Anaplastic Large Cell Lymphoma Studies:
1. Comparison of Two Induction Combination Chemotherapy Regimens Followed By High-Dose Consolidation Chemotherapy and Autologous Stem Cell Transplantation With or Without Rituximab as Maintenance Therapy in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma
2. Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma
3. Combination Chemotherapy and Radiation Therapy Plus Bone Marrow Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
4. Bevacizumab in Treating Patients With Non-Hodgkin's Lymphoma
5. BMS-247550 in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
Related Studies:
Other anaplastic large cell lymphoma Clinical Trials
Other Kentucky Clinical Trials
Other Lexington Clinical Trials
Pixantrone, Cytarabine, Methylprednisolone, and Cisplatin in Treating Patients With Aggressive Non-Hodgkin's Lymphoma in First Relapse
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