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.
- Determine the efficacy of cyproheptadine in preventing further weight loss in children
- Determine the efficacy of megestrol in preventing further weight loss in patients who
- Determine how these drugs affect body protein and fat levels in these patients.
OUTLINE: Patients receive oral cyproheptadine twice daily for 4 weeks in the absence of
unacceptable weight loss or toxicity. Patients that present with weight loss after 4 weeks
receive oral megestrol daily for 4 weeks in the absence of unacceptable weight loss or
toxicity. Patients responding to either cyprohepatadine or megestrol may continue treatment
at the discretion of the treating physician.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
- Newly diagnosed or relapsed cancer of any type, including brain tumors
- Cachexia with weight loss presumed secondary to cancer or cancer-related treatment
defined as 1 or more of the following:
- Documented weight loss of at least 5%
- Drop in growth rate 2 or more percentile ranks on standard growth charts
- Weight for height less than the tenth percentile
- No hormone-sensitive tumors (i. e., meningiomas, breast cancer, ovarian cancer, or
endometrial cancer)
PATIENT CHARACTERISTICS:
Age
- 2 to 20
Performance status
- Not specified
Life expectancy
- At least 8 weeks
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- No thromboembolic disease
- No congestive heart failure
- No recurrent or persistent hypertension (i. e., blood pressure values greater than 20%
above normal)
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No type I or II neurofibromatosis
- No glaucoma
- No chronic persistent asthma
- No gastrointestinal or genitourinary obstruction
- No peripheral edema
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No more than 8 weeks since prior chemotherapy
Endocrine therapy
- No concurrent corticosteroids except intermittent steroid use (≤ 7 days in a 4 week
period)
Radiotherapy
- No more than 8 weeks since prior radiotherapy
Surgery
- No more than 8 weeks since prior surgery
- Concurrent tumor-debulking surgery, limb-sparing surgery, or amputation allowed
Other
- More than 3 weeks since prior cyproheptadine or megestrol
- More than 3 weeks since prior dronabinol or other appetite-stimulating medications
- More than 1 week since prior parenteral nutrition or tube feedings
- No more than 8 weeks since prior other anticancer therapy
- No other concurrent appetite-stimulating medications
- No concurrent parenteral nutrition or tube feedings
- No concurrent monoamine oxidase inhibitors (e. g., moclobemide, phenelzine, or
tranylcypromine)
- Concurrent active or palliative therapy allowed
San Jorge Children's Hospital, Santurce 00912, Puerto Rico
CCOP - Bay Area Tumor Institute, Oakland, California 94609-3305, United States
Children's Hospital & Research Center Oakland, Oakland, California 94609, United States
Children's National Medical Center, Washington, District of Columbia 20010-2970, United States
All Children's Hospital, St. Petersburg, Florida 33701, United States
CCOP - Florida Pediatric, Tampa, Florida 33682-7757, United States
Kaplan Cancer Center at St. Mary's Medical Center, West Palm Beach, Florida 33407, United States
Nemours Children's Clinic, Jacksonville, Florida 32207, United States
Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola, Florida 32504, United States
St. Joseph's Children's Hospital of Tampa, Tampa, Florida 33677-4227, United States
University of Florida Shands Cancer Center, Gainesville, Florida 32610-0296, United States
MBCCOP - Medical College of Georgia Cancer Center, Augusta, Georgia 30912-4000, United States
Cancer Research Center of Hawaii, Honolulu, Hawaii 96813, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas 66160-7357, United States
Children's Hospital of New Orleans, New Orleans, Louisiana 70118, United States
Floating Hospital for Children at Tufts - New England Medical Center, Boston, Massachusetts 02111, United States
CCOP - Beaumont, Royal Oak, Michigan 48073-6769, United States
DeVos Children's Hospital, Grand Rapids, Michigan 49503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Detroit, Michigan 48236, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis, Saint Paul, Minnesota 55106-2049, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota 55455, United States
Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri 63110, United States
Tomorrows Children's Institute at Hackensack University Medical Center, Hackensack, New Jersey 07601, United States
Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States
SUNY Upstate Medical University Hospital, Syracuse, New York 13210, United States
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina 28232-2861, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina 27157-1096, United States
Children's Hospital Medical Center of Akron, Akron, Ohio 44308-1062, United States
Children's Medical Center - Dayton, Dayton, Ohio 45404-1815, United States
Columbus Children's Hospital, Columbus, Ohio 43205-2696, United States
Tod Children's Hospital, Youngstown, Ohio 44501, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital, Portland, Oregon 97227, United States
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States
Hopital Sainte Justine, Montreal, Quebec H3T 1C5, Canada
Montreal Children's Hospital at McGill University Health Center, Montreal, Quebec H3G 1A4, Canada
CCOP - Scott and White Hospital, Temple, Texas 76508, United States
CHRISTUS Santa Rosa Children's Hospital, San Antonio, Texas 78207, United States
MBCCOP - South Texas Pediatrics, San Antonio, Texas 78229-3900, United States
Methodist Cancer Center at Methodist Specialty and Transplant Hospital, San Antonio, Texas 78229-3902, United States
Vermont Cancer Center at University of Vermont, Burlington, Vermont 05405-0110, United States
Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia 23298-0121, United States
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington 98105-3916, United States
St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin 54307-9070, United States
