Trial record 1 of 181 for:
"Acute monoblastic leukemia"
Combination Chemotherapy With or Without PSC 833, Peripheral Stem Cell Transplantation, and/or Interleukin-2 in Treating Patients With Acute Myeloid Leukemia
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006363
First received: October 4, 2000
Last updated: January 7, 2013
Last verified: December 2012
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Purpose
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PSC 833 may increase the effectiveness of chemotherapy by making cancer cells more sensitive to the drugs. 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 cancer cells. This randomized phase III trial is studying giving combination chemotherapy together with PSC 833 followed by a peripheral stem cell transplant with or without interleukin-2 to see how well it works compared to combination chemotherapy alone followed by a peripheral stem cell transplant with or without interleukin-2 in treating patients with acute myeloid leukemia
| Condition | Intervention | Phase |
|---|---|---|
|
Adult Acute Basophilic Leukemia Adult Acute Eosinophilic Leukemia Adult Acute Erythroid Leukemia (M6) Adult Acute Megakaryoblastic Leukemia (M7) Adult Acute Minimally Differentiated Myeloid Leukemia (M0) Adult Acute Monoblastic Leukemia (M5a) Adult Acute Monoblastic Leukemia and Acute Monocytic Leukemia (M5) 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) Childhood Acute Basophilic Leukemia Childhood Acute Eosinophilic Leukemia Childhood Acute Erythroleukemia (M6) Childhood Acute Megakaryocytic Leukemia (M7) Childhood Acute Minimally Differentiated Myeloid Leukemia (M0) Childhood Acute Monoblastic Leukemia (M5a) Childhood Acute Monoblastic Leukemia and Acute Monocytic Leukemia (M5) Childhood Acute Monocytic Leukemia (M5b) Childhood Acute Myeloblastic Leukemia With Maturation (M2) Childhood Acute Myeloblastic Leukemia Without Maturation (M1) Childhood Acute Myelomonocytic Leukemia (M4) Childhood Myelodysplastic Syndromes de Novo Myelodysplastic Syndromes Untreated Adult Acute Myeloid Leukemia Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies |
Drug: cytarabine Drug: daunorubicin hydrochloride Drug: etoposide Drug: valspodar Biological: filgrastim Drug: busulfan Procedure: autologous hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation Biological: aldesleukin Other: clinical observation Other: pharmacological study |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase III Randomized Study of Induction Chemotherapy With or Without MDR-Modulation With PSC-833 (NSC # 648265, IND # 41121) Followed by Cytogenetic Risk-Adapted Intensification Therapy Followed by Immunotherapy With rIL-2 (NSC # 373364, IND # 1969) vs. Observation in Previously Untreated Patients With AML < 60 Years |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial acute myeloid leukemia with mutated CEBPA
PDGFRA-associated chronic eosinophilic leukemia
PDGFRB-associated chronic eosinophilic leukemia
Drug Information available for:
Busulfan
Cytarabine
Daunorubicin
Daunorubicin hydrochloride
Etoposide
Aldesleukin
Etoposide phosphate
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
Daunorubicin citrate
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Disease-free survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]An unstratified logrank test for the induction treatment comparison and a stratified logrank test for the post-remission treatment comparison will be the primary statistical methods used for treatment comparisons.
- Overall survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]An unstratified logrank test for the induction treatment comparison and a stratified logrank test for the post-remission treatment comparison will be the primary statistical methods used for treatment comparisons.
Secondary Outcome Measures:
- Estimates of disease-free survival curves [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
- Estimates of overall survival curves [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
- Toxicities and adverse events assessed using National Cancer Institute (NCI) Common Toxicity Criteria (CTC) [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]Will be tabulated.
| Enrollment: | 720 |
| Study Start Date: | November 2000 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Induction Arm I
Patients receive cytarabine IV continuously on days 1-7 and daunorubicin IV over 5-10 minutes followed by etoposide IV over 2 hours on days 1-3. Patients with 20% or greater bone marrow cellularity and greater than 5% leukemia blasts at the end of the first course receive a second course of cytarabine IV continuously on days 1-5 and daunorubicin IV over 5-10 minutes followed by etoposide IV over 2 hours on days 1 and 2.
|
Drug: cytarabine
Given IV
Other Names:
Drug: daunorubicin hydrochloride
Given IV
Other Names:
Drug: etoposide
Given IV
Other Names:
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
|
|
Experimental: Induction Arm II
Patients receive PSC 833 IV continuously on days 1-3 and cytarabine, daunorubicin, and etoposide as in arm I. Patients with 20% or greater bone marrow cellularity and greater than 5% leukemia blasts at the end of the first course receive a second course of PSC 833 IV continuously on days 1 and 2 and cytarabine, daunorubicin, and etoposide as in arm I.
|
Drug: cytarabine
Given IV
Other Names:
Drug: daunorubicin hydrochloride
Given IV
Other Names:
Drug: etoposide
Given IV
Other Names:
Drug: valspodar
Given IV
Other Names:
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
|
|
Experimental: Intensification Favorable
Patients receive HiDAC IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats no earlier than 28 days after the prior course and no later than 14 days after hematopoietic recovery for two more courses.
|
Drug: cytarabine
Given IV
Other Names:
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
|
|
Experimental: Intensification Unfavorable PBSCT Group
Patients receive etoposide IV continuously and HiDAC IV over 2 hours every 12 hours on days 1-4. Patients also receive G-CSF SC daily beginning on day 14 and continuing until PBSC collection is completed. Patients who are not able to undergo PBSCT after HiDAC/etoposide continue treatment in the non-PBSCT group. At least 4 weeks after HiDAC/etoposide recovery, patients receive oral busulfan every 6 hours on days -7 to -4 and etoposide IV over 4 hours on day -3 prior to PBSCT. Patients receive autologous PBSC infusion on day 0. Patients also receive G-CSF SC beginning on day 0 and continuing until hematopoietic recovery.
|
Drug: cytarabine
Given IV
Other Names:
Drug: etoposide
Given IV
Other Names:
Biological: filgrastim
Given SC
Other Names:
Drug: busulfan
Given orally
Other Names:
Procedure: autologous hematopoietic stem cell transplantation
Undergo autologous PBSCT
Procedure: peripheral blood stem cell transplantation
Undergo autologous PBSCT
Other Names:
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
|
|
Experimental: Intensification Unfavorable Non-PBSCT Group
Patients receive etoposide, HiDAC, and G-CSF as in the PBSCT group. After hematopoietic recovery, patients then receive HiDAC IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats no earlier than 28 days after prior course and no later than 14 days after hematopoietic recovery for one more course.
|
Drug: cytarabine
Given IV
Other Names:
Drug: etoposide
Given IV
Other Names:
Biological: filgrastim
Given SC
Other Names:
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
|
|
Experimental: Immunotherapy Arm I
Patients begin therapy no later than 120 days after the first day of the last course of HiDAC treatment OR day 0 of PBSCT. Patients receive low-dose IL-2 SC on days 1-14, 19-28, 33-42, 47-56, 61-70, and 75-90. In addition, patients receive high-dose IL-2 SC on days 15-17, 29-31, 43-45, 57-59, and 71-73.
|
Biological: aldesleukin
Given SC
Other Names:
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
|
|
Active Comparator: Immunotherapy Arm II
Patients are observed and receive no further therapy.
|
Other: clinical observation
Undergo clinical observation
Other Name: observation
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 15 Years to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Unequivocal histologic diagnosis of AML (> 20% blasts in the bone marrow based on the World Health Organization [WHO] and/or French-American-British Cooperative group [FAB] classifications), excluding M3 (acute promyelocytic leukemia); patients with antecedent myelodysplasia are eligible for treatment on this trial only if there was no bone marrow biopsy showing myelodysplastic syndrome (MDS) > 3 months prior to enrollment; patients with therapy-related MDS or therapy-related AML or a chronic myeloproliferative disorder are not eligible
No prior treatment for leukemia or myelodysplasia with four permissible exceptions:
- Emergency leukapheresis
- Emergency treatment for hyperleukocytosis with hydroxyurea
- Cranial radiation therapy (RT) for central nervous system (CNS) leukostasis (one dose only)
- Growth factor/cytokine support
Contacts and Locations More Information
No publications provided by National Cancer Institute (NCI)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006363 History of Changes |
| Other Study ID Numbers: | NCI-2012-02824, CALGB-19808, U10CA031946, CDR0000068234 |
| Study First Received: | October 4, 2000 |
| Last Updated: | January 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Congenital Abnormalities Neoplasms Leukemia Leukemia, Basophilic, Acute Leukemia, Eosinophilic, Acute Leukemia, Erythroblastic, Acute Leukemia, Megakaryoblastic, Acute Leukemia, Monocytic, Acute Leukemia, Myeloid, Acute Leukemia, Myeloid Leukemia, Myelomonocytic, Acute Myelodysplastic Syndromes Preleukemia Leukemia, Myelomonocytic, Chronic Hypereosinophilic Syndrome |
Neoplasms by Histologic Type Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Myelodysplastic-Myeloproliferative Diseases Eosinophilia Leukocyte Disorders Busulfan Cytarabine Etoposide phosphate Aldesleukin Daunorubicin Etoposide Interleukin-2 |
ClinicalTrials.gov processed this record on May 22, 2013