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 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 responding to either cyprohepatadine or megestrol may continue treatment at the discretion of the treating physician.
Minimum eligible age: 2 Years.
Maximum eligible age: 20 Years.
Eligible gender(s): Both.
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
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James H. Feusner, MD, Phone: 510-428-3689, Email: jfeusner@mail.cho.org
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Dina Hankin, PhD, Phone: 510-305-2050, Email: dhankin@mail.cho.org
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Emad K. Salman, MD, Phone: 239-432-3333, Email: emad.salman@leememorial.org
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Narayana Gowda, MD, Phone: 561-844-6363, Email: doctorgowda@hotmail.com
Nemours Children's Clinic, Jacksonville, Florida 32207, United States; Recruiting
Eric Sandler, MD, Phone: 904-858-3817, Email: esandler@nemours.org
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John F. Kelleher, MD, Phone: 850-505-4790
St. Joseph's Children's Hospital of Tampa, Tampa, Florida 33677-4227, United States; Recruiting
Cameron K. Tebbi, MD, Phone: 813-870-4387, Email: cameron.tebbi@baycare.org
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Stephen P. Hunger, MD, Phone: 352-265-0680, Email: hungesp@peds.ufl.edu
MBCCOP - Medical College of Georgia Cancer Center, Augusta, Georgia 30912-4000, United States; Recruiting
Roger A. Vega, MD, Phone: 706-721-3626, Email: rvega@mail.mcg.edu
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Luis A. Clavell, MD, Phone: 787-728-1575, Email: luis.clavell@sjcms.com
Cancer Research Center of Hawaii, Honolulu, Hawaii 96813, United States; Recruiting
Robert W. Wilkinson, MD, Phone: 808-586-2979
St. Vincent Indianapolis Hospital, Indianapolis, Indiana 46260, United States; Recruiting
Randy A. Hock, MD, PhD, MMM, Phone: 317-338-9825
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas 66160-7357, United States; Recruiting
Robert C. Trueworthy, MD, Phone: 913-588-2244, Email: rtruewor@kumc.edu
Baystate Regional Cancer Program at D'Amour Center for Cancer Care, Springfield, Massachusetts 01199, United States; Recruiting
Philippa G. Sprinz, MD, Phone: 413-794-5316, Email: phillippa.sprinz@bhs.org
Floating Hospital for Children at Tufts - New England Medical Center, Boston, Massachusetts 02111, United States; Recruiting
Jenepher Nalyanya, Phone: 617-636-5535
CCOP - Beaumont, Royal Oak, Michigan 48073-6769, United States; Recruiting
David A. Decker, MD, FACP, Phone: 248-551-3230, Email: ddecker@beaumont.edu
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David R. Freyer, DO, Phone: 616-391-3088
Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri 63110, United States; Recruiting
Robert J. Hayashi, MD, Phone: 314-454-4353
Tomorrows Children's Institute at Hackensack University Medical Center, Hackensack, New Jersey 07601, United States; Recruiting
Jennifer Sommers, Phone: 201-996-5803
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Jami Frost, MD, Phone: 505-272-5980
Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States; Recruiting
Clinical Trials Office - Roswell Park Cancer Institute, Phone: 877-275-7724
SUNY Upstate Medical University Hospital, Syracuse, New York 13210, United States; Recruiting
Ronald L. Dubowy, MD, Phone: 315-464-7601, Email: dubowyr@upstate.edu
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina 28232-2861, United States; Recruiting
Daniel P. McMahon, MD, Phone: 704-355-8226, Email: dmcmahon@carolinas.org
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Steven J. Kuerbitz, MD, Phone: 330-543-8731, Email: skuerbitz@chmca.org
Children's Medical Center - Dayton, Dayton, Ohio 45404-1815, United States; Recruiting
Emmett H. Broxson, MD, FAAP, Phone: 937-641-3432, Email: broxsone@childrensdayton.org
Columbus Children's Hospital, Columbus, Ohio 43205-2696, United States; Recruiting
Amanda M. Termuhlen, MD, Phone: 614-722-6569
Tod Children's Hospital - Forum Health, Youngstown, Ohio 44501, United States; Recruiting
Ayman Saleh, MD, FAAP, Phone: 330-884-0576, Email: asaleh@forumhealth.org
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Janice F. Olson, MD, Phone: 503-413-1706
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States; Recruiting
Clinical Trials Office - Children's Hospital of Pittsburgh, Phone: 412-692-5573
Hopital Sainte Justine, Montreal, Quebec H3T 1C5, Canada; Recruiting
Caroline Laverdiere, MD, Phone: 514-345-4969, Email: caroline.laverdiere@umontreal.ca
Montreal Children's Hospital at McGill University Health Center, Montreal, Quebec H3G 1A4, Canada; Recruiting
Carolyn R. Freeman, MB, BS, FRCPC, Phone: 514-412-4400, Email: carolyn.freeman@muhc.mcgill.ca
East Tennessee Children's Hospital, Knoxville, Tennessee 37901, United States; Recruiting
Teresa Hutchens, Phone: 865-541-8560
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Lucas Wong, MD, Phone: 254-724-5079, Email: lwong@swmail.sw.org
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Anne-Marie Langevin, MD, Phone: 210-704-2028, Email: langevin@uthscsa.edu
Methodist Cancer Center at Methodist Specialty and Transplant Hospital, San Antonio, Texas 78229-3902, United States; Recruiting
Jaime Estrada, MD, Phone: 210-575-3161
Wilford Hall Medical Center, Lackland Air Force Base, Texas 78236-5300, United States; Recruiting
James A. Barber, MD, Phone: 210-292-6689
Vermont Cancer Center at University of Vermont, Burlington, Vermont 05405-0110, United States; Recruiting
Christina Senn, Phone: 802-656-9402, Email: christina.senn@med.uvm.edu
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Nancy L. Dunn, MD, Phone: 804-628-1232, Email: nldunn@hsc.vcu.edu
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