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

Completed · Phase 2

Conditions studied: Brain Tumor, Central Nervous System Tumors, Cachexia, Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases, Unspecified Childhood Solid Tumor, Protocol Specific

In brief

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.

Key facts

Study ID

NCT00066248

Run by

University of South Florida

People needed

70

Starts

2003-06-01

Expected to finish

2007-08-01

Last updated by the study team

2014-02-03

Who can join

Age: 2 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• CCOP - Bay Area Tumor Institute — Oakland, California, United States
• Children's Hospital & Research Center Oakland — Oakland, California, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• University of Florida Shands Cancer Center — Gainesville, Florida, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• Sacred Heart Cancer Center at Sacred Heart Hospital — Pensacola, Florida, United States
• All Children's Hospital — St. Petersburg, Florida, United States
• St. Joseph's Children's Hospital of Tampa — Tampa, Florida, United States
• CCOP - Florida Pediatric — Tampa, Florida, United States
• Kaplan Cancer Center at St. Mary's Medical Center — West Palm Beach, Florida, United States
• MBCCOP - Medical College of Georgia Cancer Center — Augusta, Georgia, United States
• Cancer Research Center of Hawaii — Honolulu, Hawaii, United States
• Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center — Kansas City, Kansas, United States
• Children's Hospital of New Orleans — New Orleans, Louisiana, United States
• Floating Hospital for Children at Tufts - New England Medical Center — Boston, Massachusetts, United States
• Van Elslander Cancer Center at St. John Hospital and Medical Center — Detroit, Michigan, United States
• DeVos Children's Hospital — Grand Rapids, Michigan, United States
• CCOP - Beaumont — Royal Oak, Michigan, United States
• University of Minnesota Cancer Center — Minneapolis, Minnesota, United States
• Children's Hospitals and Clinics of Minnesota - Minneapolis — Saint Paul, Minnesota, United States
• Siteman Cancer Center at Barnes-Jewish Hospital — St Louis, Missouri, United States
• Tomorrows Children's Institute at Hackensack University Medical Center — Hackensack, New Jersey, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• SUNY Upstate Medical University Hospital — Syracuse, New York, United States
• Blumenthal Cancer Center at Carolinas Medical Center — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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