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

• Status: Completed
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: All

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 anemia in children with cancer undergoing chemotherapy, and to assess its effect on the quality of life.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ortho Biotech Products, L.P.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)