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

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Cyproheptadine and megestrol may improve appetite and help prevent weight loss in children with cancer.

PURPOSE: This phase II trial is studying how well cyproheptadine and megestrol work in improving appetite and preventing weight loss in children with cachexia caused by cancer or cancer treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of South Florida
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyproheptadine; Megestrol; Megestrol Acetate

Criteria

INCLUSION CRITERIA:

• Any cachectic patient with weight loss presumed secondary to cancer or cancer related therapy 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 this study.

• 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 the past 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 administered for more than 7 days in a 4 week period. Calculate anticipated intermittent steroid use in 4-week intervals through the 8-week period during which study agent may be administered (4 weeks for Periactin and potentially 4 weeks for Megace.

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

• Patients taking dronabinol (Marinol) or other appetite-stimulating medications during the past three weeks or patients expected to be prescribed appetite-stimulating medications 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 of meningiomas and are thus excluded from this study.32

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

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

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

• Patients who are pregnant.