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Combination Chemotherapy Plus PSC 833 Followed by Interleukin-2 in Treating Older Patients With Acute Myeloid Leukemia 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 Combination Chemotherapy Plus PSC 833 Followed by Interleukin-2 in Treating Older Patients With Acute Myeloid Leukemia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy Plus PSC 833 Followed by Interleukin-2 in Treating Older Patients With Acute Myeloid Leukemia Clinical research trials and Combination Chemotherapy Plus PSC 833 Followed by Interleukin-2 in Treating Older Patients With Acute Myeloid Leukemia 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 Combination Chemotherapy Plus PSC 833 Followed by Interleukin-2 in Treating Older Patients With Acute Myeloid Leukemia. Combination Chemotherapy Plus PSC 833 Followed by Interleukin-2 in Treating Older Patients With Acute Myeloid Leukemia 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 Combination Chemotherapy Plus PSC 833 Followed by Interleukin-2 in Treating Older Patients With Acute Myeloid Leukemia clinical trial. Participants frequently get the best healthcare available for their Combination Chemotherapy Plus PSC 833 Followed by Interleukin-2 in Treating Older Patients With Acute Myeloid Leukemia 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 > Combination Chemotherapy Plus PSC 833 Followed by Interleukin-2 in Treating Older Patients With Acute Myeloid Leukemia  Combination Chemotherapy Plus PSC 833 Followed by Interleukin-2 in Treating Older Patients With Acute Myeloid Leukemia
Combination Chemotherapy Plus PSC 833 Followed by Interleukin-2 in Treating Older Patients With Acute Myeloid Leukemia
For Condition: adult acute poorly differentiated monocytic leukemia (M5a),adult acute myeloblastic leukemia with maturation (M2),adult acute differentiated monocytic leukemia (M5b),adult acute minimally differentiated myeloid leukemia (M0),adult acute myelomonocytic leukemia (M4),adult acute megakaryocytic leukemia (M7),adult acute erythroleukemia (M6),adult acute myeloblastic leukemia without maturation (M1),untreated adult acute myeloid leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
Synopsis: RATIONALE: Some cancers become resistant to chemotherapy drugs. Combining PSC 833 with more than one chemotherapy drug may reduce resistance to the drugs and allow the cancer cells to be killed. Combining interleukin-2 with combination chemotherapy plus PSC 833 may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without PSC 833 followed by interleukin-2 or no further therapy in treating older patients who have acute myeloid leukemia.
Details: OBJECTIVES: I. Determine whether the addition of PSC 833 to induction chemotherapy improves the complete response rate of patients with acute myeloid leukemia (PSC 833 treatment arm closed as of 8/15/99). II. Determine whether the addition of PSC 833 to induction and consolidation chemotherapy improves survival in this patient population (PSC 833 treatment arm closed as of 8/15/99). III. Determine whether the administration of low-dose and intermittent high- dose interleukin-2 after chemotherapy prolongs disease-free survival in this patient population. PROTOCOL OUTLINE: This is a partially randomized, multicenter study. Patients are stratified according to participating center and disease characteristics (de novo acute myeloid leukemia (AML) versus AML with antecedent myelodysplasia). Patients are randomized to one of two maintenance therapy arms. Arm I: Patients receive cytarabine IV continuously over 7 days and daunorubicin IV bolus followed by etoposide IV over 2 hours on days 1-3. Arm II: (Closed as of 8/15/99) Patients receive treatment as in arm I with the addition of PSC 833 induction. A loading dose of PSC 833 IV is given over 2 hours, followed by a 74-hour continuous infusion of PSC 833 beginning 2 hours before daunorubicin and etoposide. Patients may receive a second induction course if residual leukemia is present in the bone marrow. Patients who experience a complete remission (CR) and meet certain other criteria receive postremission chemotherapy consisting of cytarabine IV continuously over 5 days plus daunorubicin IV followed by etoposide IV over 2 hours on days 1 and 2. Patients who are randomized to receive PSC 833 during induction chemotherapy receive a loading dose of PSC 833 before beginning a 48-hour continuous infusion of PSC 833 concurrently with cytarabine/daunorubicin/etoposide postremission chemotherapy. After completing postremission chemotherapy, patients are randomized to a no further treatment group or interleukin-2 (IL-2) immunotherapy. Treatment begins within 5 months of postremission chemotherapy. IL-2 immunotherapy consists of low-dose subcutaneous (SC) IL-2 on days 1-14, 19-28, 33-42, 47-56, 61-70, and 75-90 and high-dose bolus SC IL-2 on days 15-17, 29-31, 43-45, 57-59, and 71-73. Patients are followed every 2 months for 2 years, every 6 months for 2 years, annually until the tenth year, and then at relapse. PROJECTED ACCRUAL: Approximately 640 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 60 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed acute myeloid leukemia (AML), all FAB except M3 (acute promyelocytic leukemia) - History of antecedent myelodysplasia allowed - No prior treatment for AML or myelodysplasia except: Emergency leukapheresis; Emergency treatment for hyperleukocytosis with hydroxyurea; Single-dose cranial radiotherapy for CNS --Prior/Concurrent Therapy-- - Biologic therapy: See Disease Characteristics - Chemotherapy: See Disease Characteristics; No other concurrent chemotherapy - Endocrine therapy: No concurrent hormonal therapy except for nondisease-related conditions (e.g., insulin for diabetes or estrogens or progestins for gynecologic conditions); No concurrent steroids (including as antiemetics) except for adrenal failure or septic shock - Radiotherapy: See Disease Characteristics; No concurrent palliative radiotherapy - Surgery: Not specified - Other: No concurrent medications that interact with cyclosporine --Patient Characteristics-- - Age: 60 and over - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified - Other: Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MariaBaer, Study Chair, Cancer and Leukemia Group B
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
St. Barnabas Medical Center
Livingston, New Jersey, 07039
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Additional Information:
Study ID Numbers: CDR0000066022; CLB-9720
Study Start Date: January 1998
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003190
Other Adult Acute Megakaryocytic Leukemia (m7) Studies:
1. Combination Chemotherapy Plus PSC 833 Followed by Interleukin-2 in Treating Older Patients With Acute Myeloid Leukemia
2. Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia
3. Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia
4. Combination Chemotherapy With or Without G-CSF in Treating Older Patients With Acute Myeloid Leukemia
5. High Dose Chemotherapy, Peripheral Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Acute Myeloid Leukemia
Related Studies:
Other adult acute megakaryocytic leukemia (M7) Clinical Trials
Other New York Clinical Trials
Other Syracuse Clinical Trials
Combination Chemotherapy Plus PSC 833 Followed by Interleukin-2 in Treating Older Patients With Acute Myeloid Leukemia
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