|
Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia Clinical research trials and Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia. Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia clinical trial. Participants oftentimes recieve the finest healthcare available for their Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia  Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia
Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia
For Condition: recurrent childhood acute lymphoblastic leukemia,recurrent adult acute lymphoblastic leukemia,recurrent adult acute myeloid leukemia,recurrent childhood acute myeloid leukemia
Status: Recruiting
Sponsor(s): Fred Hutchinson Cancer Research 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. Interleukin-2 may stimulate a person's white blood cells to kill leukemia cells. Treating donor white blood cells with interleukin-2 in the laboratory may help them kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy plus donor white blood cells treated with interleukin-2 in treating patients who have acute myeloid leukemia or acute lymphoid leukemia.
Details: OBJECTIVES: - Determine the maximum tolerated dose of interleukin-2 following donor lymphocyte infusion and chemotherapy in patients with relapsed acute myeloid or lymphoid leukemia after allogeneic peripheral blood stem cell transplantation. - Determine the toxicity and efficacy of this regimen in these patients. OUTLINE: This is a dose escalation study of interleukin-2 (IL-2). Patients are stratified according to disease status after chemotherapy (acute myeloid leukemia (AML) in complete remission (CR) vs acute lymphoid leukemia (ALL) or AML not in CR). Patients receive one of three induction chemotherapy regimens, depending on type of leukemia, prior treatment, and response. - Regimen 1: Patients receive high dose cytarabine IV over 2 hours twice a day on days 1, 3, and 5. - Regimen 2: Patients receive mitoxantrone IV over 15 minutes and etoposide IV over 30 minutes on days 1-5. - Regimen 3: Patients receive fludarabine IV over 30 minutes on days 1-5, cytarabine IV over 2 hours on days 1-4, and filgrastim (G-CSF) subcutaneously beginning on day 1 and continuing until blood counts recover. Patients with extramedullary relapse receive local radiotherapy. Patients with ALL or CNS relapse receive intrathecal methotrexate with or without hydrocortisone and cytarabine. Patients receive one donor lymphocyte infusion IV over 15-30 minutes within 28-60 days after starting chemotherapy. On the same day, IL-2 IV is administered over 24 hours for 5 days. After 2 days rest, IL-2 is again administered continuously for 10 days. Cohorts of 5 patients receive escalating doses of IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 5 patients experience dose limiting toxicities. Up to 40 patients are treated at the MTD. Patients are followed monthly for 3 months, and then every 6 months thereafter. PROJECTED ACCRUAL: Approximately 11-15 patients per year will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Relapsed acute myeloid leukemia or acute lymphoid leukemia after allogeneic peripheral blood stem cell transplantation (PBSCT), documented by 1 of the following: - Morphologic relapse defined as 1 or more of the following: - Peripheral blasts in absence of growth factor therapy - Bone marrow blasts greater than 5% of nucleated cells - Extramedullary (CNS, testicular, or other sites) - Flow cytometric relapse defined as appearance in peripheral blood or bone marrow of cells with abnormal immunophenotype consistent with leukemia recurrence and noted at pretransplant - Cytogenetic relapse defined as: - Appearance in 1 or more metaphases from bone marrow or peripheral blood cells of nonconstitutional cytogenetic abnormality noted in at least 1 cytogenetic study performed prior to transplant OR - New abnormality known to be associated with leukemia - Allogeneic PBSCT from related (HLA identical and 1 antigen mismatch) OR unrelated (match) donor - Must have achieved complete remission after PBSCT - Current donor must be same as prior donor - Age 10 and over PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - SWOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - See Disease Characteristics Hepatic: - Bilirubin no greater than 2.0 mg/dL Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No congestive heart failure requiring diuretics - No uncontrolled arrhythmia Pulmonary: - No pulmonary dysfunction requiring oxygen therapy - No pneumonia or severe obstruction - FEV_1 at least 50% of predicted OR no greater than 50% decline from baseline - No severe restrictive lung disease (total lung capacity less than 60% or 50% declined from baseline) not due to leukemia Other: - No sepsis, aspergillosis, or other active infection PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified Other: - No concurrent cyclosporine or tacrolimus during induction chemotherapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MaryFlowers, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 98109-1024
United States
Recruiting Mary Flowers 206-667-6557
Additional Information:
Study ID Numbers: CDR0000067777; NCI-H00-0057,FHCRC-1380.00
Study Start Date:
Record last reviewed: June 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005802
Other Recurrent Childhood Acute Myeloid Leukemia Studies:
1. BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia
2. FR901228 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
3. Dolastatin 10 in Treating Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia
4. Carboplatin Plus Topotecan in Treating Patients With Relapsed Acute Myelogenous Leukemia
5. Oblimersen and Gemtuzumab Ozogamicin in Treating Older Patients With Relapsed Acute Myeloid Leukemia
Related Studies:
Other recurrent childhood acute myeloid leukemia Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia
|
|
|
|
|
|
|
|
