Induction Intensification in Treating Infants With Newly Diagnosed Acute Lymphoblastic Leukemia - Full Text View

Sponsor:	Children's Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002756

Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and giving them as induction intensification may kill more cancer cells.

PURPOSE: This phase II trial is studying how well induction intensification works in treating infants with newly diagnosed acute lymphocytic leukemia.

Condition	Intervention	Phase
Leukemia	Biological: filgrastim Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: etoposide Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: therapeutic hydrocortisone Drug: vincristine sulfate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	INDUCTION INTENSIFICATION AND ALLOGENEIC BONE MARROW TRANSPLANT IN INFANT ALL: A PEDIATRIC ONCOLOGY GROUP PILOT STUDY Induction Intensification and Allogeneic Bone Marrow Transplant in Infant ALL: A Children's Oncology Group Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Transplantation Cancer Leukemia, Childhood

Drug Information available for: Hydrocortisone acetate Cyclophosphamide Hydrocortisone 6-Mercaptopurine Prednisone Vincristine Leucovorin Methotrexate Cytarabine hydrochloride Daunorubicin Daunorubicin hydrochloride Etoposide Citrovorum factor Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Etoposide phosphate Filgrastim Hydrocortisone 21-sodium succinate Cytarabine Hydrocortisone cypionate Leucovorin Calcium Vincristine sulfate Cortisol succinate Cortisol 21-phosphate Folinic acid calcium salt pentahydrate Mercaptopurine L-Asparaginase

U.S. FDA Resources

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

Primary Outcome Measures:

Feasibility of intensification [ Designated as safety issue: No ]
Event-free survival [ Designated as safety issue: No ]
Comparison of event-free survival rates in infants with and without leukemic blasts translocations [ Designated as safety issue: No ]

Secondary Outcome Measures:

Correlation of minimal residual disease at completion of induction, beginning of continuation, and at completion of therapy with patient outcome [ Designated as safety issue: No ]
Clinical prognostic features associated with outcome [ Designated as safety issue: No ]
Correlation of biologic characteristics of leukemia cells at diagnosis with outcome [ Designated as safety issue: No ]
Patterns of gene expression [ Designated as safety issue: No ]

Estimated Enrollment:	104
Study Start Date:	June 1996

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
- No infants less than 36 weeks' gestation
- CNS or testicular disease permitted
No B-cell ALL or acute myeloid leukemia
Previously untreated except for the following:
- Steroid treatment within 48 hours of diagnosis allowed with physical examination and differential CBC immediately prior to beginning steroids
Concurrent registration on protocol POG-9900 (ALL classification study) required
Patients registered on POG-9407 are eligible for the pharmacokinetic part of the study

PATIENT CHARACTERISTICS:

Age:

Under 1 at diagnosis

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

No uncontrolled infection
Adequate major organ function

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Not specified

Endocrine therapy:

See Disease Characteristics
No concurrent chronic steroid treatment

Radiotherapy:

Not specified

Surgery:

Not specified

Other:

No other concurrent anticancer therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002756

Show 140 Study Locations

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Zoann E. Dreyer, MD

Texas Children's Cancer Center

More Information

Additional Information:

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

Publications:

Thompson PA, Murry DJ, Rosner GL, Lunagomez S, Blaney SM, Berg SL, Camitta BM, Dreyer ZE, Bomgaars LR. Methotrexate pharmacokinetics in infants with acute lymphoblastic leukemia. Cancer Chemother Pharmacol. 2006 Nov 29; [Epub ahead of print]

Fernandez CV, Kodish E, Taweel S, Shurin S, Weijer C; Children's Oncology Group. Disclosure of the right of research participants to receive research results: an analysis of consent forms in the Children's Oncology Group. Cancer. 2003 Jun 1;97(11):2904-9.

Study ID Numbers:	CDR0000064693, COG-P9407, POG-9407
Study First Received:	November 1, 1999
Last Updated:	February 21, 2009
ClinicalTrials.gov Identifier:	NCT00002756 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

untreated childhood acute lymphoblastic leukemia
acute undifferentiated leukemia

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Anti-Infective Agents
Hydrocortisone
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
6-Mercaptopurine
Hormones
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Etoposide

Nucleic Acid Synthesis Inhibitors
Asparaginase
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Immune System Diseases
Vincristine
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Neoplasms
Hydrocortisone acetate
Antineoplastic Agents, Phytogenic
Antimetabolites
Daunorubicin
Leukemia, Lymphoid

ClinicalTrials.gov processed this record on November 27, 2009