Lymphoma Clinical Trial
Official title:
The Effect of Cyproheptadine Hydrochloride (Periactin) and Megestrol Acetate (Megace) on Weight in Children With Cancer/Treatment Related Cachexia
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | August 2007 |
Est. primary completion date | August 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 20 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Canada | Hopital Sainte Justine | Montreal | Quebec |
Canada | Montreal Children's Hospital at McGill University Health Center | Montreal | Quebec |
Puerto Rico | San Jorge Children's Hospital | Santurce | |
United States | Children's Hospital Medical Center of Akron | Akron | Ohio |
United States | MBCCOP - Medical College of Georgia Cancer Center | Augusta | Georgia |
United States | Floating Hospital for Children at Tufts - New England Medical Center | Boston | Massachusetts |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Vermont Cancer Center at University of Vermont | Burlington | Vermont |
United States | Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina |
United States | Columbus Children's Hospital | Columbus | Ohio |
United States | Children's Medical Center - Dayton | Dayton | Ohio |
United States | Van Elslander Cancer Center at St. John Hospital and Medical Center | Detroit | Michigan |
United States | University of Florida Shands Cancer Center | Gainesville | Florida |
United States | DeVos Children's Hospital | Grand Rapids | Michigan |
United States | St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin |
United States | Tomorrows Children's Institute at Hackensack University Medical Center | Hackensack | New Jersey |
United States | Cancer Research Center of Hawaii | Honolulu | Hawaii |
United States | Nemours Children's Clinic | Jacksonville | Florida |
United States | Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas |
United States | University of Minnesota Cancer Center | Minneapolis | Minnesota |
United States | Children's Hospital of New Orleans | New Orleans | Louisiana |
United States | CCOP - Bay Area Tumor Institute | Oakland | California |
United States | Children's Hospital & Research Center Oakland | Oakland | California |
United States | Sacred Heart Cancer Center at Sacred Heart Hospital | Pensacola | Florida |
United States | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Legacy Emanuel Hospital and Health Center & Children's Hospital | Portland | Oregon |
United States | Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia |
United States | CCOP - Beaumont | Royal Oak | Michigan |
United States | Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis | Missouri |
United States | Children's Hospitals and Clinics of Minnesota - Minneapolis | Saint Paul | Minnesota |
United States | CHRISTUS Santa Rosa Children's Hospital | San Antonio | Texas |
United States | MBCCOP - South Texas Pediatrics | San Antonio | Texas |
United States | Methodist Cancer Center at Methodist Specialty and Transplant Hospital | San Antonio | Texas |
United States | Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington |
United States | All Children's Hospital | St. Petersburg | Florida |
United States | SUNY Upstate Medical University Hospital | Syracuse | New York |
United States | CCOP - Florida Pediatric | Tampa | Florida |
United States | St. Joseph's Children's Hospital of Tampa | Tampa | Florida |
United States | CCOP - Scott and White Hospital | Temple | Texas |
United States | Children's National Medical Center | Washington | District of Columbia |
United States | Kaplan Cancer Center at St. Mary's Medical Center | West Palm Beach | Florida |
United States | Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina |
United States | Tod Children's Hospital | Youngstown | Ohio |
Lead Sponsor | Collaborator |
---|---|
University of South Florida | National Cancer Institute (NCI) |
United States, Canada, Puerto Rico,
Couluris M, Mayer JL, Freyer DR, Sandler E, Xu P, Krischer JP. The effect of cyproheptadine hydrochloride (periactin) and megestrol acetate (megace) on weight in children with cancer/treatment-related cachexia. J Pediatr Hematol Oncol. 2008 Nov;30(11):791 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of study agents as measured by changes in weight at baseline, and 4 weeks after the beginning of study treatment | 4-8 weeks | No | |
Secondary | Effect of study agents on protein and fat levels as measured by pre-albumin and lipid profile at baseline, and 4 weeks after the beginning of study treatment | 4-8 weeks | No |
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