Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment

INCLUSION CRITERIA:

• Any cachectic patient with weight loss presumed secondary to cancer or cancer relatedtherapy is eligible. Cachexia is defined as having one or more of the following:

• documented history of weight loss > 5%

• drop in growth rate two or more percentile ranks on standard growth charts,

• weight for height less than the tenth percentile.

• Patients with newly diagnosed or relapsed cancer of any type, including brain tumors.

• Patients who are receiving active or palliative therapy are eligible.

• If patients have completed treatment for cancer (surgery, chemotherapy, radiotherapy)within 8 weeks of study registration, they are also eligible.

• Patients must be ≥ 2 years and < 21 years of age at the time of admission to thisstudy.

• Patients must have a predicted life expectancy of at least eight weeks.

EXCLUSION CRITERIA:

• Patients who are currently taking or who have taken Periactin and/or Megace during thepast three weeks are not eligible.

• Patients receiving corticosteroid or monoamine oxidase (MAO) inhibitor therapy. (Intermittent steroid use is permitted IF you anticipate it will not be administeredfor more than 7 days in a 4 week period. Calculate anticipated intermittent steroiduse in 4-week intervals through the 8-week period during which study agent may beadministered (4 weeks for Periactin and potentially 4 weeks for Megace.

• Patients who have received parenteral nutrition or tube feedings within 1 week ofstarting this protocol or patients who are expected to require parenteral nutrition ortube feedings during the 4-week course of this study.

• Patients taking dronabinol (Marinol) or other appetite-stimulating medications duringthe past three weeks or patients expected to be prescribed appetite-stimulatingmedications during the 4-week course of this study.

• Patients with hormone sensitive tumors specifically meningiomas, breast cancer,ovarian cancer, and endometrial carcinoma.31, 32

• Children with neurofibromatosis, type I or II, are at risk for the development ofmeningiomas and are thus excluded from this study.32

• Children with glaucoma, chronic persistent asthma, or gastrointestinal (GI) orgenitourinary (GU) obstruction.

• Patients with recurrent and/or persistent hypertension, defined as blood pressurevalues >20% above normal.

• Patients with thromboembolic disease, congestive heart failure, or peripheral edema.

• Patients who are pregnant.