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

NCT00066248 | Completed Phase 2 DMC

• 3 other identifiers: SCUSF 0205HLMCC-0205U10CA081920
• Study Type: interventional
• Target: 70
• Locations: 3 countries
• Sites: 43

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  4-8 weeks

Secondary Outcomes (1)

• 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

Study Arms (2)

Subjects that respond to Periactin

EXPERIMENTAL

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: cyproheptadine hydrochloride

Non-responders to Periactin- Megace Arm

EXPERIMENTAL

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: cyproheptadine hydrochloride; Drug: megestrol acetate

Interventions

cyproheptadine hydrochloride DRUG

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.

Also known as: Periactin

Non-responders to Periactin- Megace Arm; Subjects that respond to Periactin

megestrol acetate DRUG

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.

Also known as: Megace

Non-responders to Periactin- Megace Arm

Eligibility Criteria

• Age: 2 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead
• National Cancer Institute (NCI): collaborator

Study Sites (43)

CCOP - Bay Area Tumor Institute

Oakland, California, 94609-3305, United States

Location

Children's Hospital & Research Center Oakland

Oakland, California, 94609, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

University of Florida Shands Cancer Center

Gainesville, Florida, 32610-0296, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Sacred Heart Cancer Center at Sacred Heart Hospital

Pensacola, Florida, 32504, United States

Location

All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

St. Joseph's Children's Hospital of Tampa

Tampa, Florida, 33677-4227, United States

Location

CCOP - Florida Pediatric

Tampa, Florida, 33682-7757, United States

Location

Kaplan Cancer Center at St. Mary's Medical Center

West Palm Beach, Florida, 33407, United States

Location

MBCCOP - Medical College of Georgia Cancer Center

Augusta, Georgia, 30912-4000, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

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

Kansas City, Kansas, 66160-7357, United States

Location

Children's Hospital of New Orleans

New Orleans, Louisiana, 70118, United States

Location

Floating Hospital for Children at Tufts - New England Medical Center

Boston, Massachusetts, 02111, United States

Location

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

Detroit, Michigan, 48236, United States

Location

DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Beaumont

Royal Oak, Michigan, 48073-6769, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Children's Hospitals and Clinics of Minnesota - Minneapolis

Saint Paul, Minnesota, 55106-2049, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Tomorrows Children's Institute at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308-1062, United States

Location

Columbus Children's Hospital

Columbus, Ohio, 43205-2696, United States

Location

Children's Medical Center - Dayton

Dayton, Ohio, 45404-1815, United States

Location

Tod Children's Hospital

Youngstown, Ohio, 44501, United States

Location

Legacy Emanuel Hospital and Health Center & Children's Hospital

Portland, Oregon, 97227, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

CHRISTUS Santa Rosa Children's Hospital

San Antonio, Texas, 78207, United States

Location

MBCCOP - South Texas Pediatrics

San Antonio, Texas, 78229-3900, United States

Location

Methodist Cancer Center at Methodist Specialty and Transplant Hospital

San Antonio, Texas, 78229-3902, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Vermont Cancer Center at University of Vermont

Burlington, Vermont, 05405-0110, United States

Location

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298-0121, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105-3916, United States

Location

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54307-9070, United States

Location

Montreal Children's Hospital at McGill University Health Center

Montreal, Quebec, H3G 1A4, Canada

Location

Hopital Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

San Jorge Children's Hospital

Santurce, 00912, Puerto Rico

Location

Related Publications (1)

• 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. doi: 10.1097/MPH.0b013e3181864a5e.

  PMID: 18989154 RESULT

MeSH Terms

Conditions

Brain Neoplasms; Central Nervous System Neoplasms; Cachexia; Leukemia; Lymphoma; Myelodysplastic Syndromes; Myelodysplastic-Myeloproliferative Diseases; Spinal Cord Neoplasms; Medulloblastoma; Astrocytoma; Oligodendroglioma; Optic Nerve Glioma; Familial ependymoma; Choroid Plexus Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid, Accelerated Phase; Blast Crisis; Leukemia, Myeloid, Chronic-Phase; Leukemia, Myelomonocytic, Juvenile; Recurrence; Leukemia, Hairy Cell; Burkitt Lymphoma; Dendritic Cell Sarcoma, Interdigitating; Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative; Leukemia, Myelomonocytic, Chronic

Interventions

Cyproheptadine; Megestrol Acetate

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Spinal Cord Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neuroectodermal Tumors, Primitive; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Optic Nerve Neoplasms; Cranial Nerve Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Diseases; Optic Nerve Diseases; Eye Diseases; Cerebral Ventricle Neoplasms; Leukemia, Lymphoid; Leukemia, B-Cell; Chronic Disease; Disease Attributes; Pathologic Processes; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Myeloproliferative Disorders; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Histiocytic Disorders, Malignant; Histiocytosis

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Jennifer L. Mayer, MD

  H. Lee Moffitt Cancer Center and Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2003
• First Posted: August 7, 2003
• Study Start: June 1, 2003
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: February 3, 2014

Record last verified: 2014-01

Locations

PR (1); US (40); CA (2)