The Effect of Cyproheptadine Hydrochloride (Periactin) and Megestrol Acetate (Megace) on Weight in Children With Cancer/Treatment Related Cachexia
Phase 2
2 Years
20 Years
2 Years
20 Years
Not Enrolling
Both
Brain Tumor, Central Nervous System Tumors, Cachexia, Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases, Unspecified Childhood Solid Tumor, Protocol Specific
Both
Brain Tumor, Central Nervous System Tumors, Cachexia, Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases, Unspecified Childhood Solid Tumor, Protocol Specific
Trial Information
The Effect of Cyproheptadine Hydrochloride (Periactin) and Megestrol Acetate (Megace) on Weight in Children With Cancer/Treatment Related Cachexia
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 responding to either cyproheptadine or megestrol may continue treatment
at the discretion of the treating physician.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
Inclusion Criteria
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Efficacy of study agents as measured by changes in weight at baseline, and 4 weeks after the beginning of study treatment
Outcome Time Frame:
4-8 weeks
Safety Issue:
No
Principal Investigator
Jennifer L. Mayer, MD
Investigator Role:
Study Chair
Investigator Affiliation:
H. Lee Moffitt Cancer Center and Research Institute
Authority:
United States: Data and Safety Monitoring Board
Study ID:
SCUSF 0205
NCT ID:
NCT00066248
Start Date:
June 2003
Completion Date:
April 2008
Related Keywords:
- Brain Tumor
- Central Nervous System Tumors
- Cachexia
- Leukemia
- Lymphoma
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Diseases
- Unspecified Childhood Solid Tumor, Protocol Specific
- cachexia
- unspecified childhood solid tumor
- childhood spinal cord neoplasm
- recurrent childhood medulloblastoma
- untreated childhood medulloblastoma
- childhood high-grade cerebral astrocytoma
- childhood low-grade cerebral astrocytoma
- recurrent childhood cerebellar astrocytoma
- recurrent childhood cerebral astrocytoma
- untreated childhood cerebellar astrocytoma
- childhood oligodendroglioma
- recurrent childhood brain stem glioma
- recurrent childhood visual pathway glioma
- hypothalamic glioma
- untreated childhood brain stem glioma
- untreated childhood visual pathway
- childhood supratentorial primitive neuroectodermal tumor
- childhood craniopharyngioma
- childhood infratentorial ependymoma
- childhood supratentorial ependymoma
- newly diagnosed childhood ependymoma
- recurrent childhood ependymoma
- childhood choroid plexus tumor
- childhood central nervous system germ cell tumor
- childhood acute lymphoblastic leukemia in remission
- recurrent childhood acute lymphoblastic leukemia
- untreated childhood acute lymphoblastic leukemia
- childhood acute myeloid leukemia in remission
- recurrent childhood acute myeloid leukemia
- untreated childhood acute myeloid leukemia
- other myeloid malignancies
- refractory chronic lymphocytic leukemia
- stage I chronic lymphocytic leukemia
- stage II chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- accelerated phase chronic myelogenous leukemia
- blastic phase chronic myelogenous leukemia
- chronic phase chronic myelogenous leukemia
- meningeal chronic myelogenous leukemia
- relapsing chronic myelogenous leukemia
- juvenile myelomonocytic leukemia
- recurrent/refractory childhood Hodgkin lymphoma
- stage I childhood Hodgkin lymphoma
- stage II childhood Hodgkin lymphoma
- stage III childhood Hodgkin lymphoma
- stage IV childhood Hodgkin lymphoma
- AIDS-related peripheral/systemic lymphoma
- AIDS-related primary CNS lymphoma
- progressive hairy cell leukemia, initial treatment
- refractory hairy cell leukemia
- untreated hairy cell leukemia
- recurrent childhood lymphoblastic lymphoma
- stage I childhood lymphoblastic lymphoma
- stage II childhood lymphoblastic lymphoma
- stage III childhood lymphoblastic lymphoma
- stage IV childhood lymphoblastic lymphoma
- recurrent childhood small noncleaved cell lymphoma
- stage I childhood small noncleaved cell lymphoma
- stage II childhood small noncleaved cell lymphoma
- stage III childhood small noncleaved cell lymphoma
- stage IV childhood small noncleaved cell lymphoma
- recurrent childhood large cell lymphoma
- stage I childhood large cell lymphoma
- stage II childhood large cell lymphoma
- stage III childhood large cell lymphoma
- stage IV childhood large cell lymphoma
- recurrent childhood brain tumor
- atypical chronic myeloid leukemia
- myelodysplastic/myeloproliferative disease
- childhood chronic myelogenous leukemia
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- chronic myelomonocytic leukemia
- Brain Neoplasms
- Cachexia
- Leukemia
- Lymphoma
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Nervous System Neoplasms
- Lymphoma, Non-Hodgkin
- Central Nervous System Neoplasms
- Myelodysplastic-Myeloproliferative Diseases
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
| CCOP - Florida Pediatric | Tampa, Florida 33682-7757 |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
| Children's National Medical Center | Washington, District of Columbia 20010-2970 |
| Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
| Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
| Nemours Children's Clinic | Jacksonville, Florida 32207 |
| All Children's Hospital | St. Petersburg, Florida 33701 |
| Children's Hospital of New Orleans | New Orleans, Louisiana 70118 |
| CCOP - Beaumont | Royal Oak, Michigan 48073-6769 |
| Children's Hospital Medical Center of Akron | Akron, Ohio 44308 |
| Children's Medical Center - Dayton | Dayton, Ohio 45404 |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
| University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
| Sacred Heart Cancer Center at Sacred Heart Hospital | Pensacola, Florida 32504 |
| Kaplan Cancer Center at St. Mary's Medical Center | West Palm Beach, Florida 33407 |
| Floating Hospital for Children at Tufts - New England Medical Center | Boston, Massachusetts 02111 |
| SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
| Legacy Emanuel Hospital and Health Center & Children's Hospital | Portland, Oregon 97227 |
| St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
| Vermont Cancer Center at University of Vermont | Burlington, Vermont 05405-0075 |
| MBCCOP - Medical College of Georgia Cancer Center | Augusta, Georgia 30912-3730 |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis, Minnesota 55404 |
| Tod Children's Hospital | Youngstown, Ohio 44501 |
| Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
| Methodist Cancer Center at Methodist Specialty and Transplant Hospital | San Antonio, Texas 78229-3902 |
| MBCCOP - South Texas Pediatrics | San Antonio, Texas 78229-3900 |
| St. Joseph's Children's Hospital of Tampa | Tampa, Florida 33677-4227 |
| DeVos Children's Hospital | Grand Rapids, Michigan 49503 |
| Columbus Children's Hospital | Columbus, Ohio 43205-2696 |
| Children's Hospital & Research Center Oakland | Oakland, California 94609 |
| Tomorrows Children's Institute at Hackensack University Medical Center | Hackensack, New Jersey 07601 |
| CHRISTUS Santa Rosa Children's Hospital | San Antonio, Texas 78207 |
