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Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Leukemia Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Leukemia conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Leukemia Clinical research trials and Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Leukemia health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Leukemia. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Leukemia Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Leukemia clinical trial. Human subjects often get the best healthcare available for their Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Leukemia condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Leukemia  Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Leukemia
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Leukemia
For Condition: secondary acute myeloid leukemia,adult acute lymphoblastic leukemia,adult acute myeloid leukemia,childhood acute myeloid leukemia,childhood acute lymphoblastic leukemia
Status: Suspended
Sponsor(s): Herbert Irving Comprehensive 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. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill leukemia cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation and interleukin-2 in treating patients who have acute leukemia.
Details: OBJECTIVES: - Determine the efficacy of busulfan, cyclophosphamide, and etoposide followed by autologous peripheral blood stem cell transplantation and interleukin-2 in patients with high-risk acute leukemia. - Determine the efficacy of immunomodulatory therapies in terms of relapse-free survival of these patients treated with this regimen. - Determine the hematopoietic reconstitution, relapse, and survival of these patients treated with this regimen. - Determine the toxicity of this regimen in these patients. OUTLINE: Following a course of mobilization chemotherapy, patients receive priming therapy comprising filgrastim (G-CSF) and interleukin-2 through the completion of leukapheresis. Patients then receive oral busulfan 4 times daily on days -8 through -5, cyclophosphamide IV continuously on days -4 and -3, and etoposide IV over 2 hours on day -4. For patients unable to receive cyclophosphamide and etoposide, melphalan IV is administered instead on days -3 and -2. Autologous peripheral blood stem cells (PBSC) are reinfused on day 0. Patients then receive G-CSF daily beginning on day 0 and continuing until blood counts recover followed by interleukin-2 subcutaneously daily beginning at the completion of G-CSF therapy and continuing for 6 months. Patients are followed weekly for 1 month and then monthly thereafter. PROJECTED ACCRUAL: A total of 19-25 patients will be accrued for this study within 3-5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed acute leukemia - High-risk due to any of the following: - Cytogenetic abnormalities involving 5q, 7q, 8q, 11q23, or t(9;22) - WBC greater than 100,000/mm3 - Prior myelodysplastic syndrome - Complete remission (CR) lasting less than 12 months - No favorable cytogenetic parameters (e.g., t(15;17), inv16, or t(8;21)) - CR following standard anti-leukemic therapy confirmed by bone marrow evaluation - Second and third CR allowed - Ineligible for higher priority national or institutional study or allogeneic peripheral blood stem cell transplantation PATIENT CHARACTERISTICS: Age: - Any age Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics Hepatic: - Bilirubin less than 1.5 times normal - SGOT or SGPT less than 1.5 times normal Renal: - Creatinine less than 1.5 times normal Cardiovascular: - LVEF at least 45% if receiving cyclophosphamide - Normal electrocardiogram OR - Approval by cardiologist Pulmonary: - DLCO less than 60% predicted OR - Approval by pulmonologist Other: - Not pregnant or nursing - No concurrent illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesHesdorffer, Study Chair, Columbia Presbyterian Medical Center
Herbert Irving Comprehensive Cancer Center at Columbia University
New York City, New York, 10032
United States
Additional Information:
Study ID Numbers: CDR0000068386; CPMC-CAMP-27,CPMC-IRB-8872,NCI-G00-1889
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008190
Other Childhood Acute Lymphoblastic Leukemia Studies:
1. Monoclonal Antibody, Cyclophosphamide, and Radiation Therapy Followed by Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome
2. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Leukemia
3. Development of Strategies to Increase Enrollment in Clinical Trials for Children With Cancer
4. Gemtuzumab Ozogamicin in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia Undergoing Remission Induction and Intensification Therapy
Related Studies:
Other childhood acute lymphoblastic leukemia Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Leukemia
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