Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment - Full Text View

Sponsor:	H. Lee Moffitt Cancer Center and Research Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00066248

Purpose

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.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors Cachexia Leukemia Lymphoma Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Unspecified Childhood Solid Tumor, Protocol Specific	Drug: cyproheptadine hydrochloride Drug: megestrol acetate	Phase II

Study Type:	Interventional
Study Design:	Supportive Care, Open Label
Official Title:	The Effect of Cyproheptadine Hydrochloride (Periactin) and Megestrol Acetate (Megace) on Weight in Children With Cancer/Treatment Related Cachexia

Resource links provided by NLM:

MedlinePlus related topics: Cancer Hodgkin Disease Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Weight Control

Drug Information available for: Cyproheptadine hydrochloride Cyproheptadine Megestrol acetate Megestrol

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Efficacy of study agents as measured by changes in weight at baseline, and 4 weeks after the beginning of study treatment

Secondary Outcome Measures:

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

Estimated Enrollment:	70
Study Start Date:	June 2003
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Detailed Description:

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 cyprohepatadine 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.

Eligibility

Ages Eligible for Study:	2 Years to 20 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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%
- 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066248

Hide Study Locations

Locations

United States, California
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
Children's Hospital & Research Center Oakland
Oakland, California, United States, 94609
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Florida
All Children's Hospital
St. Petersburg, Florida, United States, 33701
CCOP - Florida Pediatric
Tampa, Florida, United States, 33682-7757
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0296
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Sacred Heart Cancer Center at Sacred Heart Hospital
Pensacola, Florida, United States, 32504
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, United States, 33677-4227
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, United States, 33407
United States, Georgia
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912-4000
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
United States, Louisiana
Children's Hospital of New Orleans
New Orleans, Louisiana, United States, 70118
United States, Massachusetts
Floating Hospital for Children at Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
CCOP - Beaumont
Royal Oak, Michigan, United States, 48073-6769
DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Van Elslander Cancer Center at St. John Hospital and Medical Center
Detroit, Michigan, United States, 48236
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis
Saint Paul, Minnesota, United States, 55106-2049
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Tomorrows Children's Institute at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308-1062
Children's Medical Center - Dayton
Dayton, Ohio, United States, 45404-1815
Columbus Children's Hospital
Columbus, Ohio, United States, 43205-2696
Tod Children's Hospital
Youngstown, Ohio, United States, 44501
United States, Oregon
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland, Oregon, United States, 97227
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
CHRISTUS Santa Rosa Children's Hospital
San Antonio, Texas, United States, 78207
MBCCOP - South Texas Pediatrics
San Antonio, Texas, United States, 78229-3900
Methodist Cancer Center at Methodist Specialty and Transplant Hospital
San Antonio, Texas, United States, 78229-3902
United States, Vermont
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States, 05405-0110
United States, Virginia
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0121
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105-3916
United States, Wisconsin
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-9070
Canada, Quebec
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, Canada, H3G 1A4
Puerto Rico
San Jorge Children's Hospital
Santurce, Puerto Rico, 00912

Sponsors and Collaborators

H. Lee Moffitt Cancer Center and Research Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Jennifer L. Mayer, MD

H. Lee Moffitt Cancer Center and Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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):791-7.

Study ID Numbers:	CDR0000309056, MCC-0205
Study First Received:	August 6, 2003
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00066248 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

cachexia
unspecified childhood solid tumor, protocol specific
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 and hypothalamic glioma
untreated childhood brain stem glioma
untreated childhood visual pathway and hypothalamic glioma

recurrent childhood supratentorial primitive neuroectodermal tumor
untreated 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 and other myeloid malignancies

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Contraceptives, Oral
Physiological Effects of Drugs
Cyproheptadine
Cachexia
Central Nervous System Neoplasms
Body Weight
Preleukemia
Serotonin Antagonists
Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Weight Loss
Body Weight Changes

Contraceptives, Oral, Synthetic
Antipruritics
Dermatologic Agents
Nervous System Neoplasms
Appetite Stimulants
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Hormonal
Hematologic Diseases
Nervous System Diseases
Myeloproliferative Disorders
Histamine Agents
Anti-Allergic Agents
Neoplasms
Histamine H1 Antagonists

ClinicalTrials.gov processed this record on November 27, 2009