Leukemia Clinical Trial
Official title:
Treatment of Newly Diagnosed Childhood AML Using a Timed-Sequential Remission Induction and Consolidation Followed by Single Dose Melphalan With Peripheral Stem Cell Rescue: A POG Pilot Study
Verified date | July 2014 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give
higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by
melphalan and peripheral stem cell transplantation in treating children who have newly
diagnosed acute myeloid leukemia that has not been treated previously.
Status | Completed |
Enrollment | 35 |
Est. completion date | March 2007 |
Est. primary completion date | October 2002 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 21 Years |
Eligibility |
DISEASE CHARACTERISTICS: Histologically proven, previously untreated primary acute myeloid
leukemia (AML) Isolated granulocytic sarcoma (myeloblastoma) allowed Patients with
cytopenias and bone marrow blasts greater than 5% but less than 30% eligible only if there
is karyotypic abnormality characteristic of de novo AML (t(8;21), inv16, t(9;11), etc.) OR
unequivocal presence of megakaryoblasts No acute promyelocytic leukemia (M3) No Down
syndrome PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Uric acid no greater than 8.0 mg/dL Cardiovascular: Cardiac function normal by echocardiogram Pulmonary: No uncontrolled, life threatening pneumonia Other: No uncontrolled, life threatening sepsis or meningitis Not pregnant Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: No prior therapy |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Montreal Children's Hospital | Montreal | Quebec |
United States | Emory University Hospital - Atlanta | Atlanta | Georgia |
United States | Johns Hopkins Oncology Center | Baltimore | Maryland |
United States | University of Alabama Comprehensive Cancer Center | Birmingham | Alabama |
United States | Massachusetts General Hospital Cancer Center | Boston | Massachusetts |
United States | Children's Memorial Hospital, Chicago | Chicago | Illinois |
United States | Simmons Cancer Center - Dallas | Dallas | Texas |
United States | Children's Hospital of Michigan | Detroit | Michigan |
United States | Cook Children's Medical Center - Fort Worth | Fort Worth | Texas |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Tomorrows Children's Institute | Hackensack | New Jersey |
United States | Nemours Children's Clinic | Jacksonville | Florida |
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | Midwest Children's Cancer Center | Milwaukee | Wisconsin |
United States | Mount Sinai School of Medicine | New York | New York |
United States | Lucile Packard Children's Hospital at Stanford | Palo Alto | California |
United States | Cardinal Glennon Children's Hospital | Saint Louis | Missouri |
United States | Children's Hospital and Health Center | San Diego | California |
United States | Maine Children's Cancer Program | Scarborough | Maine |
United States | Arizona Cancer Center | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
United States, Canada,
Hurwitz CA, Chang M, Graham M, et al.: Timed-sequential remission induction and intensification followed by stem cell rescue for childhood AML -a POG pilot study. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1553, 2002.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility and toxicity of an intensive regimen that uses timed-sequential therapy | To determine the feasibility and toxicity of an intensive regimen that uses timed-sequential therapy as a strategy for both remission induction and consolidation of newly diagnosed children with AML. | Length of study | Yes |
Primary | Feasibility and toxicity of a single high dose of melphalan with peripheral stem cell rescue | To test the feasibility and toxicity of a single high dose of melphalan with peripheral stem cell rescue following an intense timed-sequential induction and consolidation. | Length of study | Yes |
Secondary | Make observations regarding PCR evidence of Minimal Residual Disease | To make observations regarding PCR evidence of Minimal Residual Disease in patients with relevant specific translocations who obtain a clinical remission. | Length of study | No |
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