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Trial: NCT00003190 [RDF]

Label NCT00003190
Slug nct00003190
Trialid NCT00003190
Lookup name NCT00003190
Provenance http://clinicaltrials.gov/show/NCT00003190?displayxml=true
Lastchanged date June 3, 2013
Firstreceived results date
Firstreceived date November 1, 1999
Id info nct id NCT00003190
Overall status Completed
Id info secondary id CALGB-9720
Biospec retention
Required header link text Link to the current ClinicalTrials.gov record.
Enrollment 640
Number of arms 2
Is section 801 No
Is fda regulated Yes
Brief title Combination Chemotherapy With or Without Valspodar in Treating Patients With Previously Untreated Acute Myeloid Leukemia
Acronym
Official title Phase III Study of MDR Modulation With PSC-833 (NSC #648265) Followed by Immunotherapy With rIL-2 (NSC #373364) vs. No Further Therapy in Previously Untreated Patients With AML >60 Years
Study type Interventional
Id info nct alias
Completion date
Verification date June 2013
Why stopped
Id info org study id NCI-2012-02793
Required header url https://clinicaltrials.gov/show/NCT00003190
Study design Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Source National Cancer Institute (NCI)
Primary completion date August 2002
Brief summary
Number of groups
Required header download date ClinicalTrials.gov processed this data on September 08, 2016
Phase Phase 3
Start date January 1998
Has expanded access No
Biospec descr
Detailed description PRIMARY OBJECTIVES: I. To determine whether the addition of PSC-833 to induction chemotherapy improves complete response rates and whether the addition of PSC-833 to induction and consolidation chemotherapy improves survival for patients with AML >= 60 years. II. To determine whether the administration of low-dose, subcutaneous rIL-2 immunotherapy with intermittent high-dose boluses after chemotherapy prolongs disease-free survival. 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: 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.
Condition browse c93bb704218dbfd4ef15187b2b3a46a5
Intervention browse e55bcedbc6e9213804f9d79ae21f5f22
Responsible party 015b495dfd0be1a85fcb46d41f363abd
Overall contact None
Overall contact backup None
Sponsor group c165a369fd9845217790cd90ac3d544c
Oversight info United States: Food and Drug Administration (Oversight_info)
Eligibility 159a05369600aec4cc8983cc184c18d1
Keywords None
Conditions Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With T(16;16)(p13;q22), Adult Acute Myeloid Leukemia With T(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Untreated Adult Acute Myeloid Leukemia
Locations 387e4f2839ed06378f277a345376cd8e
Links None
Results references None
Arm groups Arm II (valspodar, daunorubicin, etoposide, cytarabine) (Arm Group), Arm I (cytarabine, daunorubicin, etoposide) (Arm Group)
Location countries United States
Interventions cytarabine (Intervention), valspodar (Intervention), etoposide (Intervention), daunorubicin hydrochloride (Intervention)
Secondary outcomes None
References None
Primary outcomes d2fe2628297f0747992ddc6332fc8b9a, dc4bc067ed2d6904b108cfc754f4359e
Removed countries None
Overall officials a79811796c23921715165e73cf56482f