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Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 2 Years - 20 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00066248
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of South Florida
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jennifer L. Mayer, MD
Principal Investigator Affiliation H. Lee Moffitt Cancer Center and Research Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Completed
Countries Canada, Puerto Rico, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Tumor, Central Nervous System Tumors, Cachexia, Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases, Unspecified Childhood Solid Tumor, Protocol Specific
Additional Details

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.

Arms & Interventions

Arms

Experimental: Subjects that respond to Periactin

Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks.

Experimental: Non-responders to Periactin- Megace Arm

Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks.

Interventions

Drug: - cyproheptadine hydrochloride

Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks.

Drug: - megestrol acetate

Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

CCOP - Bay Area Tumor Institute, Oakland, California

Status

Address

CCOP - Bay Area Tumor Institute

Oakland, California, 94609-3305

Oakland, California

Status

Address

Children's Hospital & Research Center Oakland

Oakland, California, 94609

Children's National Medical Center, Washington, District of Columbia

Status

Address

Children's National Medical Center

Washington, District of Columbia, 20010-2970

Gainesville, Florida

Status

Address

University of Florida Shands Cancer Center

Gainesville, Florida, 32610-0296

Nemours Children's Clinic, Jacksonville, Florida

Status

Address

Nemours Children's Clinic

Jacksonville, Florida, 32207

Pensacola, Florida

Status

Address

Sacred Heart Cancer Center at Sacred Heart Hospital

Pensacola, Florida, 32504

All Children's Hospital, St. Petersburg, Florida

Status

Address

All Children's Hospital

St. Petersburg, Florida, 33701

Tampa, Florida

Status

Address

St. Joseph's Children's Hospital of Tampa

Tampa, Florida, 33677-4227

CCOP - Florida Pediatric, Tampa, Florida

Status

Address

CCOP - Florida Pediatric

Tampa, Florida, 33682-7757

West Palm Beach, Florida

Status

Address

Kaplan Cancer Center at St. Mary's Medical Center

West Palm Beach, Florida, 33407

Augusta, Georgia

Status

Address

MBCCOP - Medical College of Georgia Cancer Center

Augusta, Georgia, 30912-4000

Cancer Research Center of Hawaii, Honolulu, Hawaii

Status

Address

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813

Kansas City, Kansas

Status

Address

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7357

Children's Hospital of New Orleans, New Orleans, Louisiana

Status

Address

Children's Hospital of New Orleans

New Orleans, Louisiana, 70118

Boston, Massachusetts

Status

Address

Floating Hospital for Children at Tufts - New England Medical Center

Boston, Massachusetts, 02111

Detroit, Michigan

Status

Address

Van Elslander Cancer Center at St. John Hospital and Medical Center

Detroit, Michigan, 48236

DeVos Children's Hospital, Grand Rapids, Michigan

Status

Address

DeVos Children's Hospital

Grand Rapids, Michigan, 49503

CCOP - Beaumont, Royal Oak, Michigan

Status

Address

CCOP - Beaumont

Royal Oak, Michigan, 48073-6769

University of Minnesota Cancer Center, Minneapolis, Minnesota

Status

Address

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455

Saint Paul, Minnesota

Status

Address

Children's Hospitals and Clinics of Minnesota - Minneapolis

Saint Paul, Minnesota, 55106-2049

Saint Louis, Missouri

Status

Address

Siteman Cancer Center at Barnes-Jewish Hospital

Saint Louis, Missouri, 63110

Hackensack, New Jersey

Status

Address

Tomorrows Children's Institute at Hackensack University Medical Center

Hackensack, New Jersey, 07601

Roswell Park Cancer Institute, Buffalo, New York

Status

Address

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001

SUNY Upstate Medical University Hospital, Syracuse, New York

Status

Address

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210

Charlotte, North Carolina

Status

Address

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861

Winston-Salem, North Carolina

Status

Address

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096

Akron, Ohio

Status

Address

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308-1062

Columbus Children's Hospital, Columbus, Ohio

Status

Address

Columbus Children's Hospital

Columbus, Ohio, 43205-2696

Children's Medical Center - Dayton, Dayton, Ohio

Status

Address

Children's Medical Center - Dayton

Dayton, Ohio, 45404-1815

Tod Children's Hospital, Youngstown, Ohio

Status

Address

Tod Children's Hospital

Youngstown, Ohio, 44501

Portland, Oregon

Status

Address

Legacy Emanuel Hospital and Health Center & Children's Hospital

Portland, Oregon, 97227

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania

Status

Address

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213

CHRISTUS Santa Rosa Children's Hospital, San Antonio, Texas

Status

Address

CHRISTUS Santa Rosa Children's Hospital

San Antonio, Texas, 78207

MBCCOP - South Texas Pediatrics, San Antonio, Texas

Status

Address

MBCCOP - South Texas Pediatrics

San Antonio, Texas, 78229-3900

San Antonio, Texas

Status

Address

Methodist Cancer Center at Methodist Specialty and Transplant Hospital

San Antonio, Texas, 78229-3902

CCOP - Scott and White Hospital, Temple, Texas

Status

Address

CCOP - Scott and White Hospital

Temple, Texas, 76508

Burlington, Vermont

Status

Address

Vermont Cancer Center at University of Vermont

Burlington, Vermont, 05405-0110

Richmond, Virginia

Status

Address

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298-0121

Seattle, Washington

Status

Address

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105-3916

Green Bay, Wisconsin

Status

Address

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54307-9070

International Sites

Montreal, Quebec, Canada

Status

Address

Montreal Children's Hospital at McGill University Health Center

Montreal, Quebec, H3G 1A4

Hopital Sainte Justine, Montreal, Quebec, Canada

Status

Address

Hopital Sainte Justine

Montreal, Quebec, H3T 1C5

San Jorge Children's Hospital, Santurce, Puerto Rico

Status

Address

San Jorge Children's Hospital

Santurce, , 00912