Megestrol Acetate in Treating Weight Loss or Anorexia in Young Patients With Malignancies Who Are Undergoing Radiation Therapy and/or Chemotherapy

Phase 2

Terminated

Brief Summary: RATIONALE: Megestrol acetate may help improve appetite and lessen weight loss caused by cancer. PURPOSE: This clinical trial studies megestrol acetate in treating weight loss or anorexia in young patients with malignancies who are undergoing radiation therapy and/or chemotherapy.

Detailed Description: PRIMARY OBJECTIVES:Proportion of Patients Who Maintain Weight or Experience Weight Gain.

SECONDARY OBJECTIVES:BMI Trends, Caloric Intake, Weight Maintenance Over Time, Toxicity Profile as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.

OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive oral megestrol acetate 1-2 times (10 mg/kg dose if once daily or 5 mg/kg dose if twice daily) daily for 4 weeks. ARM B (control): Patients are observed for weight loss and gain for 4 weeks. After completion of study treatment, patients are followed up for 12 weeks.

Recruitment & Eligibility

Inclusion Criteria

Any pediatric patient with an underlying diagnosis of a malignancy (excluding hematological malignancies like leukemias and lymphomas)
≥5% weight loss from diagnosis of primary malignancy (must be currently on chemotherapy and/or radiation therapy or scheduled to receive cancer therapy OR ≥5% weight loss following bone marrow transplant (autologous or allogeneic blood/bone marrow) and not actively receiving corticosteroid therapy
Negative pregnancy test done =< 7 days prior to registration for women of childbearing potential only

Exclusion Criteria

Receiving tube feedings or parenteral nutrition
Evidence of ascites
Current (within the past 28 days) or planned treatment with adrenal steroids (short-term use of dexamethasone around days of intravenous chemotherapy is allowed for protection against emesis), androgens, progestational agents, or appetite stimulants (e.g., dronabinol)
Known mechanical obstruction of the alimentary tract, malabsorption, or intractable vomiting (> 5 episodes/week)
History of unresectable brain tumor or cancer metastatic to the brain
History of thromboembolic disease
Insulin-requiring diabetes
Congestive heart failure and/or uncontrolled hypertension
Anticoagulation
Previous history of thrombosis (personal and immediate family)
Concurrent corticosteroid therapy (except as an antiemetic)

Arm && Interventions

Group	Intervention	Description
Arm A	megestrol acetate	Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
Arm B	clinical observation	Patients have clinical observation for weight loss and gain for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Who Maintain Weight or Experience Weight Gain	4 weeks	A patient will be defined as "success" if he/she maintains or gains weight at the end if Initial Treatment compared with baseline of study entry.

Secondary Outcome Measures

Name	Time	Method
Weight Maintenance Over Time	4 weeks
BMI Trends	4 weeks
Caloric Intake	4 weeks
Toxicity Profile	4 weeks	Number of patients with grade 3+ non-hematologic adverse events using Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.0