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

PURPOSE: Clinical trial to study the effectiveness of cyproheptadine and megestrol in improving appetite and preventing weight loss in children who have cachexia caused by cancer or cancer treatment.

Condition	Treatment or Intervention
Cachexia childhood Hodgkin's lymphoma childhood brain tumor childhood non-Hodgkin's lymphoma childhood solid tumor hematopoietic and lymphoid cancer	Drug: cyproheptadine  Drug: megestrol  Procedure: anticachectic therapy  Procedure: nutritional support  Procedure: supportive care/therapy

OBJECTIVES:

• Determine the efficacy of cyproheptadine in preventing further weight loss in children with cancer or cancer treatment-related cachexia.
• Determine the efficacy of megestrol in preventing further weight loss in patients who don't respond to cyproheptadine.
• 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 are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

Ages Eligible for Study:  2 Years   -   20 Years,  Genders Eligible for Study:  Both

Criteria

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% within 1 month of study entry
• 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

Florida
      All Children's Hospital, St. Petersburg,  Florida,  33701,  United States; Recruiting
      CCOP - Florida Pediatric, Tampa,  Florida,  33682-7757,  United States; Recruiting
      Children's Hospital of Southwest Florida, Fort Myers,  Florida,  33908,  United States; Recruiting
      Nemours Children's Clinic, Jacksonville,  Florida,  32207,  United States; Recruiting
      Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola,  Florida,  32504,  United States; Recruiting
      Shands Cancer Center at the University of Florida Health Science Center, Gainesville,  Florida,  32610-0296,  United States; Recruiting
      St. Joseph's Children's Hospital, Tampa,  Florida,  33677-4227,  United States; Recruiting
Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States; Recruiting
      CHRISTUS Santa Rosa Children’s Hospital, San Antonio,  Texas,  78207,  United States; Recruiting
      MBCCOP - South Texas Pediatrics, San Antonio,  Texas,  78229-3900,  United States; Recruiting
      Methodist Cancer Center at Methodist Specialty and Transplant Hospital, San Antonio,  Texas,  78229-3902,  United States; Recruiting
      Wilford Hall Medical Center, Lackland Air Force Base,  Texas,  78236-5300,  United States; Recruiting
Puerto Rico
      San Jorge Childrens Hospital, Santurce,  00912,  Puerto Rico; Recruiting

Study chairs or principal investigators

Jennifer L R Mayer, MD,  Study Chair,  H. Lee Moffitt Cancer Center and Research Institute   

Study ID Numbers:  CDR0000309056; MCC-0205
Record last reviewed:  August 2004
Record first received:  August 6, 2003
ClinicalTrials.gov Identifier:  NCT00066248
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-10