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Brain TumorPhase 2NCT00066248

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

A Phase 2 study testing cyproheptadine hydrochloride and megestrol acetate in people with Brain Tumor and Central Nervous System Tumors, run by University of South Florida at 43 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 2 to 20 years
What is being tested?
cyproheptadine hydrochloride and megestrol acetate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
43 sitesin 3 countries
Study dates
Jun 2003to Aug 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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 locations and contacts

43 sites in 3 countries.

43 sites in 3 countries

United States40 sites

  • Children's Hospital Medical Center of Akron

    Akron, Ohio, 44308-1062

  • MBCCOP - Medical College of Georgia Cancer Center

    Augusta, Georgia, 30912-4000

  • Floating Hospital for Children at Tufts - New England Medical Center

    Boston, Massachusetts, 02111

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Vermont Cancer Center at University of Vermont

    Burlington, Vermont, 05405-0110

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Columbus Children's Hospital

    Columbus, Ohio, 43205-2696

  • Children's Medical Center - Dayton

    Dayton, Ohio, 45404-1815

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

    Detroit, Michigan, 48236

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0296

  • DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-9070

  • Tomorrows Children's Institute at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207

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

    Kansas City, Kansas, 66160-7357

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Children's Hospital of New Orleans

    New Orleans, Louisiana, 70118

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609-3305

  • Children's Hospital & Research Center Oakland

    Oakland, California, 94609

  • Sacred Heart Cancer Center at Sacred Heart Hospital

    Pensacola, Florida, 32504

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Legacy Emanuel Hospital and Health Center & Children's Hospital

    Portland, Oregon, 97227

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23298-0121

  • CCOP - Beaumont

    Royal Oak, Michigan, 48073-6769

  • Children's Hospitals and Clinics of Minnesota - Minneapolis

    Saint Paul, Minnesota, 55106-2049

  • CHRISTUS Santa Rosa Children's Hospital

    San Antonio, Texas, 78207

  • MBCCOP - South Texas Pediatrics

    San Antonio, Texas, 78229-3900

  • Methodist Cancer Center at Methodist Specialty and Transplant Hospital

    San Antonio, Texas, 78229-3902

  • Children's Hospital and Regional Medical Center - Seattle

    Seattle, Washington, 98105-3916

  • Siteman Cancer Center at Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • All Children's Hospital

    St. Petersburg, Florida, 33701

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • St. Joseph's Children's Hospital of Tampa

    Tampa, Florida, 33677-4227

  • CCOP - Florida Pediatric

    Tampa, Florida, 33682-7757

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Children's National Medical Center

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

  • Kaplan Cancer Center at St. Mary's Medical Center

    West Palm Beach, Florida, 33407

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1096

  • Tod Children's Hospital

    Youngstown, Ohio, 44501

Other trials in United States

Canada2 sites

  • Montreal Children's Hospital at McGill University Health Center

    Montreal, Quebec, H3G 1A4

  • Hopital Sainte Justine

    Montreal, Quebec, H3T 1C5

Other trials in Canada

Puerto Rico1 site

  • San Jorge Children's Hospital

    Santurce, 00912

Other trials in Puerto Rico

About this study

Official title: The Effect of Cyproheptadine Hydrochloride (Periactin) and Megestrol Acetate (Megace) on Weight in Children With Cancer/Treatment Related Cachexia

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.

Read the 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 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.

Being tested
cyproheptadine hydrochloride, megestrol acetate
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
Medical subject headings
Brain Neoplasms, Central Nervous System Neoplasms, Cachexia, Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Spinal Cord Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cyproheptadine hydrochlorideDrug

    Also called 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.

  • megestrol acetateDrug

    Also called Megace

    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.

Study groups in NCT00066248
Study groupRoleWhat they receive
Subjects that respond to PeriactinExperimentalReceive 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.
Receives: Drug: cyproheptadine hydrochloride
Non-responders to Periactin- Megace ArmExperimentalReceive 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.
Receives: Drug: cyproheptadine hydrochloride; Drug: megestrol acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 4-8 weeks

Secondary outcomes (1)

  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

    Measured: 4-8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2003 (estimated)
  2. Study startJun 2003
  3. Primary completionAug 2007
  4. Study completionAug 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00066248
Sponsor's protocol ID
SCUSF 0205
Other IDs
HLMCC-0205, U10CA081920, SCUSF 0205
Status last verified
Jan 2014
First submitted
6 Aug 2003
Last updated
3 Feb 2014
Results posted
No
Data monitoring committee
Yes

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. doi: 10.1097/MPH.0b013e3181864a5e.

    PubMed 18989154

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cyproheptadine hydrochloride and megestrol acetate in people with Brain Tumor and Central Nervous System Tumors, run by University of South Florida at 43 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of study agents as measured by changes in weight at baseline, and 4 weeks after the beginning of study treatment (time frame: 4-8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00066248, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2014.

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