Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Weekly PROCRIT (Epoetin Alfa) on Anemia and Quality of Life in Children With Cancer Undergoing Myelosuppressive Chemotherapy
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of once- weekly dosing of PROCRITÂ® (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.


Options:
A: Inclusion Criteria:

- Subjects completing the planned 16 weeks of treatment on the 20010103 Anemia of Cancer protocol

Exclusion Criteria:

* Subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy
* Subjects who have other diagnoses not related to the cancer which can cause anemia
* Known history of seizure disorder
* Cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia
* Uncontrolled hypertension
* Clinically significant systemic infection or chronic inflammatory disease present at the time of enrollment
* Subject of reproductive potential who is not using adequate contraceptive precautions
* Concerns for subject's compliance with the protocol procedures
B: Inclusion Criteria:

* Chronic Kidney Disease:Glomerular filtration rate (GFR) \> 15 mL/min and \> 50 mL/min as calculated by the central lab. HB\<11 g/dL upon study enrollment. The GFR for assessment of patient eligibility will be determined using the formula derived from the Modification of Diet for Renal Disease (MDRD) Study.

Exclusion Criteria:

* Pregnant or lactating women
* Presence of uncontrolled hypertension
* Known hypersensitivity to mammalian cell-derived products or human albumin
* Active gastrointestinal bleeding
* Iron overload defined as a transferrin saturation \>70% or ferritin \>1000 ng/mL
* History of frequent blood transfusions in the past 6 months
* Unstable angina or angina pectoris at rest
* Severe chronic obstructive pulmonary disease requiring routine use of supplemental oxygen
* Severe liver dysfunction that is defined by an international normalized ratio \>2.0, not caused by an anticoagulant
* Severe malnutrition
* Active hematological disease (eg, sickle cell anemia, thalassemia)
* Active malignancy (usually defined as malignancy requiring current chemotherapy or radiotherapy)
* Patients with current seizure disorder or activity
* Patients currently receiving RRT (patient can not be on dialysis or have had a kidney transplant)
* Patients who have received Epoetin Alpha within 6 weeks prior to study entry
C: 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)
D: Inclusion Criteria:

* Critically ill patient admitted to the ICU
* Patient is anemic when entering the study (hemoglobin \</= 12.0 g/dL)

Exclusion Criteria:

* Patients with a history of blood clots (deep vein thrombosis)
* Patients with acute ischemic cardiac disease
* Patients receiving hemodialysis or peritoneal dialysis
* Patients admitted to the ICU because of acute GI bleeding
* Patients who are planned to be discharged from the ICU within 48 hours of entering the study

Answer: C