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

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 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Induction Intensification in Infant ALL: A Children's Oncology Group Study

Resource links provided by NLM:

MedlinePlus related topics: Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Hydrocortisone acetate Hydrocortisone Hydrocortisone sodium succinate Hydrocortisone cypionate Hydrocortisone butyrate Daunorubicin Daunorubicin hydrochloride Hydrocortisone valerate Hydrocortisone probutate

Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Acute Lymphoblastic Leukemia, Childhood Acute Monoblastic Leukemia Acute Myeloblastic Leukemia Type 5

U.S. FDA Resources

Further study details as provided by Children's Oncology Group:

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 ]


Enrollment:	221
Study Start Date:	June 1996
Study Completion Date:	March 2012
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Chemo (Reduced Induction) No BMT (Open February 2004)	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

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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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Kang H, Wilson CS, Harvey RC, Chen IM, Murphy MH, Atlas SR, Bedrick EJ, Devidas M, Carroll AJ, Robinson BW, Stam RW, Valsecchi MG, Pieters R, Heerema NA, Hilden JM, Felix CA, Reaman GH, Camitta B, Winick N, Carroll WL, Dreyer ZE, Hunger SP, Willman CL. Gene expression profiles predictive of outcome and age in infant acute lymphoblastic leukemia: a Children's Oncology Group study. Blood. 2012 Feb 23;119(8):1872-81. doi: 10.1182/blood-2011-10-382861. Epub 2011 Dec 30.

Salzer WL, Jones TL, Devidas M, Hilden JM, Winick N, Hunger S, Carroll WL, Camitta B, Dreyer ZE. Modifications to induction therapy decrease risk of early death in infants with acute lymphoblastic leukemia treated on Children's Oncology Group P9407. Pediatr Blood Cancer. 2012 Nov;59(5):834-9. doi: 10.1002/pbc.24132. Epub 2012 Apr 5.

Robinson BW, Devidas M, Carroll AJ, et al.: Specific MLL partner genes in infant acute lymphoblastic leukemia (ALL) associated with outcome are linked to age and white blood cell count (WBC) at diagnosis: A report on the Children's Oncology Group (COG) P9407 trial. [Abstract] Blood 114 (22): A-907, 2009.

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. 2007 May;59(6):847-53. Epub 2006 Nov 29.

Dreyer ZE, Dinndorf PA, Camitta B, Sather H, La MK, Devidas M, Hilden JM, Heerema NA, Sanders JE, McGlennen R, Willman CL, Carroll AJ, Behm F, Smith FO, Woods WG, Godder K, Reaman GH. Analysis of the role of hematopoietic stem-cell transplantation in infants with acute lymphoblastic leukemia in first remission and MLL gene rearrangements: a report from the Children's Oncology Group. J Clin Oncol. 2011 Jan 10;29(2):214-22. doi: 10.1200/JCO.2009.26.8938. Epub 2010 Dec 6.

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.


Responsible Party:	Children's Oncology Group
ClinicalTrials.gov Identifier:	NCT00002756 History of Changes
Other Study ID Numbers:	P9407, COG-P9407, POG-9407, CDR0000064693
Study First Received:	November 1, 1999
Last Updated:	February 12, 2014
Health Authority:	United States: Federal Government

Keywords provided by Children's Oncology Group:


untreated childhood acute lymphoblastic leukemia acute undifferentiated leukemia

Additional relevant MeSH terms:


Cortisol succinate Daunorubicin Hydrocortisone Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Hydrocortisone-17-butyrate Anti-Inflammatory Agents Antibiotics, Antineoplastic	Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses Topoisomerase II Inhibitors Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on March 03, 2015