Status:
COMPLETED
A Study to Evaluate the Effect of Weekly PROCRIT (Epoetin Alfa) or Placebo on Anemia and Quality of Life in Children With Cancer Undergoing Chemotherapy
Lead Sponsor:
Ortho Biotech Products, L.P.
Conditions:
Anemia
Hodgkin Disease
Eligibility:
All Genders
5-18 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of once- weekly dosing of PROCRIT® (a glycoprotein that stimulates red blood cell production) versus placebo in the treatment of ...
Detailed Description
PROCRIT® (epoetin alfa) is an analogue of erythropoetin, a hormone secreted by kidneys known to stimulate red blood cell production. PROCRIT® is approved to be given three times per week to treat anem...
Eligibility Criteria
Inclusion
- Patients with a confirmed new diagnosis of malignant solid tumor, Hodgkin's disease, Acute Lymphocytic Leukemia (ALL) or Non-Hodgkin's Lymphoma (NHL)
- scheduled to receive first myelosuppressive chemotherapy within 7 days of baseline or have received up to the second myelosuppressive chemotherapy within 60 days prior to study enrollment, and scheduled to receive chemotherapy over a minimum period of 12 weeks after study enrollment
- anemic according to age-based and gender-based criteria (hemoglobin level of \< 10.5 g/dL for boys and girls ages 5 to 12 years, \< 11.0 g/dL for girls older than 12 years, \< 12.0 g/dL for boys older than 12 years)
- have an indwelling central venous access device (e.g., subcutaneous port, external Hickman-Broviac-type catheter, or peripherally inserted central catheter) or existing peripheral intravenous catheter in place for chemotherapy administration
- both male or female patients who are reproductive potential and sexually active must be practicing an acceptable method of birth control throughout the entire study
- Parent/legal guardian must have read and signed the informed consent and patients must have provided assent, as appropriate according to state and IRB requirements
Exclusion
- Diagnosis of myeloid leukemia or other myeloid malignancy (e.g., granulocytic sarcoma)
- diagnosis of Down's Syndrome, tumor of the central nervous system (CNS) or symptomatic metastatic CNS disease (for the solid tumor/Hodgkin's Disease stratum), or presence of symptomatic CNS disease at diagnosis (for the Acute Lymphocytic Leukemia/Non-Hodgkin's Lymphoma stratum)
- scheduled to receive cranial irradiation during the study period, or has received cranial irradiation within 30 days prior to study enrollment
- have an inherited form of anemia (hemoglobinopathy, thalassemia, red cell membrane defect, red cell enzyme deficiency) or a Coombs-positive hemolytic anemia
- elevated serum creatinine based upon age of study entry ( \> 0.8 mg/dL for children younger than 10 years, \> 1.1 mg/dL for children 10 - 15 years, \> 1.4 mg/dL for children older than 15 years)
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2003
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT00261677
Start Date
August 1 2000
End Date
October 1 2003
Last Update
May 23 2011
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