| Label |
NCT00003190
|
| Slug |
nct00003190
|
| Trialid |
NCT00003190
|
| Lookup name |
NCT00003190
|
| Provenance |
http://clinicaltrials.gov/show/NCT00003190?displayxml=true
|
| Lastchanged date |
|
| Firstreceived results date |
|
| Firstreceived date |
|
| 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 |
|
| Is fda regulated |
|
| 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 |
|
| 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 August 24, 2018
|
| 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 |
05b7e82ccedf5bab688fe07e42e584bc
|
| Responsible party |
015b495dfd0be1a85fcb46d41f363abd
|
| Overall contact |
None
|
| Overall contact backup |
None
|
| Sponsor group |
c165a369fd9845217790cd90ac3d544c
|
| Oversight info |
None
|
| Eligibility |
43ac66e8db2308012b16999d5c21ff6d
|
| 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 |
f77e60348d3ce3234c48bbbc48075422,
fe61287533f446d9ee40dbcb40739608
|
| Removed countries |
None
|
| Overall officials |
a79811796c23921715165e73cf56482f
|
