Overview

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

Status:
Terminated
Trial end date:
2012-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mayo Clinic
Collaborator:
National Cancer Institute (NCI)
Treatments:
Megestrol
Megestrol Acetate
Criteria
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)