Combination Chemotherapy With or Without Lestaurtinib in Treating Infants With Newly Diagnosed Acute Lymphoblastic Leukemia - Full Text View

Sponsors and Collaborators:	Children's Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00557193

Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killing the cells or by stopping them from dividing. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving more than one drug (combination chemotherapy) together with lestaurtinib may kill more cancer cells.

PURPOSE: This phase III trial is studying giving lestaurtinib together with combination chemotherapy to see how well it works compared to combination chemotherapy alone in treating infants with newly diagnosed acute lymphoblastic leukemia.

Condition	Intervention	Phase
Leukemia	Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: etoposide Drug: lestaurtinib Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: methylprednisolone Drug: pegaspargase Drug: prednisone Drug: therapeutic hydrocortisone Drug: vincristine sulfate	Phase III

MedlinePlus related topics: Cancer Leukemia, Childhood

Drug Information available for: Cyclophosphamide Cytarabine Cytarabine hydrochloride Etoposide Mercaptopurine 6-Mercaptopurine L-Asparaginase Daunorubicin hydrochloride Daunorubicin Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Methotrexate Methylprednisolone Prednisone Vincristine sulfate Vincristine Etoposide phosphate Calcium gluconate CEP 701 Pegaspargase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized
Official Title:	A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; IND#76431; NSC#617807)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Event-free survival at 3 years [ Designated as safety issue: No ]

Secondary Outcome Measures:

Dose of lestaurtinib [ Designated as safety issue: No ]
Pharmacokinetic and pharmacodynamic profile of lestaurtinib [ Designated as safety issue: No ]
Molecular mechanisms of resistance to lestaurtinib in leukemic blasts [ Designated as safety issue: No ]
Levels of minimal residual disease [ Designated as safety issue: No ]
Gene expression patterns [ Designated as safety issue: No ]
Outcome of infants with MLL-germline ALL treated with a modified chemotherapy backbone that includes an extended continuation phase [ Designated as safety issue: No ]

Estimated Enrollment:	244
Study Start Date:	January 2008
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Post-induction therapy A Patients receive combination chemotherapy for up to 104 weeks.	Drug: asparaginase Given IV, IM, or orally Drug: cyclophosphamide Given IV, IM, or orally Drug: cytarabine Given IT Drug: daunorubicin hydrochloride Given IV, IM, or orally Drug: dexamethasone Given IV, IM, or orally Drug: etoposide Given IV, IM, or orally Drug: leucovorin calcium Given IV, IM, or orally Drug: mercaptopurine Given IV, IM, or orally Drug: methotrexate Given IT Drug: methylprednisolone Given IV, IM, or orally Drug: pegaspargase Given IV, IM, or orally Drug: prednisone Given IV, IM, or orally Drug: therapeutic hydrocortisone Given IT Drug: vincristine sulfate Given IV, IM, or orally
Post-induction therapy B: Active Comparator Patients receive a different combination chemotherapy regimen than in post-induction therapy A for up to 104 weeks.	Drug: asparaginase Given IV, IM, or orally Drug: cyclophosphamide Given IV, IM, or orally Drug: cytarabine Given IT Drug: daunorubicin hydrochloride Given IV, IM, or orally Drug: dexamethasone Given IV, IM, or orally Drug: etoposide Given IV, IM, or orally Drug: leucovorin calcium Given IV, IM, or orally Drug: mercaptopurine Given IV, IM, or orally Drug: methotrexate Given IT Drug: methylprednisolone Given IV, IM, or orally Drug: pegaspargase Given IV, IM, or orally Drug: prednisone Given IV, IM, or orally Drug: therapeutic hydrocortisone Given IT Drug: vincristine sulfate Given IV, IM, or orally
Post-induction therapy C: Experimental Patients receive lestaurtinib and a different combination chemotherapy regimen than in either post-induction therapy A or post-induction therapy B for up to 104 weeks.	Drug: asparaginase Given IV, IM, or orally Drug: cyclophosphamide Given IV, IM, or orally Drug: cytarabine Given IT Drug: daunorubicin hydrochloride Given IV, IM, or orally Drug: dexamethasone Given IV, IM, or orally Drug: etoposide Given IV, IM, or orally Drug: lestaurtinib Given orally Drug: leucovorin calcium Given IV, IM, or orally Drug: mercaptopurine Given IV, IM, or orally Drug: methotrexate Given IT Drug: methylprednisolone Given IV, IM, or orally Drug: pegaspargase Given IV, IM, or orally Drug: prednisone Given IV, IM, or orally Drug: therapeutic hydrocortisone Given IT Drug: vincristine sulfate Given IV, IM, or orally

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 1 Year
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia
- T-cell ALL allowed
- Bilineage or biphenotypic acute leukemia allowed provided the morphology and immunophenotype are predominately lymphoid
Must be < 366 days of age at diagnosis; neonates in the first month of life must be > 36 weeks gestational age at diagnosis
Must be enrolled on protocol COG-AALL03B1 prior to enrollment on this protocol
Previously untreated except for the following:
- Steroid treatment within the past 48 hours allowed, provided that a physical examination and CBC with differential were performed immediately prior to beginning steroids
- Intrathecal (IT) chemotherapy (per protocol) is allowed for patient convenience at the time of the diagnostic bone marrow or venous line placement to avoid second lumbar puncture
No B-cell ALL or acute myelogenous leukemia

PATIENT CHARACTERISTICS:

No Down syndrome

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No concurrent chronic steroid treatment for another disease
No other concurrent non-protocol chemotherapy or investigational therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557193

Show 98 Study Locations

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Joanne M. Hilden, MD	St. Vincent Indianapolis Hospital
Investigator:	Patrick A. Brown, MD	Sidney Kimmel Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000573996, COG-AALL0631
Study First Received:	November 9, 2007
Last Updated:	January 2, 2009
ClinicalTrials.gov Identifier:	NCT00557193
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

untreated childhood acute lymphoblastic leukemia
T-cell childhood acute lymphoblastic leukemia
acute undifferentiated leukemia

Study placed in the following topic categories:

Dexamethasone
Daunorubicin
Prednisone
Leukemia, Lymphoid
Hydrocortisone
Methylprednisolone
Leucovorin
Prednisolone acetate
Cyclophosphamide
6-Mercaptopurine
Etoposide phosphate
Leukemia
Pegaspargase
Methotrexate
Lymphoma

Etoposide
Dexamethasone acetate
Cytarabine
Methylprednisolone Hemisuccinate
Asparaginase
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Cortisol succinate
Methylprednisolone acetate
Vincristine
Folic Acid
Calcium, Dietary
Lymphatic Diseases
Prednisolone
Hydrocortisone acetate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Reproductive Control Agents
Antibiotics, Antineoplastic
Neuroprotective Agents
Hormones
Vitamins

Therapeutic Uses
Abortifacient Agents
Micronutrients
Dermatologic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Vitamin B Complex
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Growth Substances
Mitosis Modulators
Gastrointestinal Agents
Enzyme Inhibitors
Antimitotic Agents

ClinicalTrials.gov processed this record on January 15, 2009