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Medical Treatment of "High-Risk" Neurofibromas

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Albert Cornelius, Spectrum Health Hospitals.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00846430
First Posted: February 18, 2009
Last Update Posted: May 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Albert Cornelius, Spectrum Health Hospitals
January 16, 2009
February 18, 2009
May 21, 2015
October 2008
October 2017   (Final data collection date for primary outcome measure)
Tumor response based on evaluation of symptom assessment, tumor measurements, and MRI studies - Toxicity of treatment combinations based upon laboratory studies and physical examination [ Time Frame: Monthly physical exam first three months and then every three months after, MRI's will occur at baseline, 6, 12 and 24 months. ]
Same as current
Complete list of historical versions of study NCT00846430 on ClinicalTrials.gov Archive Site
Psychological toxicity based upon psychological evaluations - Improved quality of life based upon physical examination and performance scales [ Time Frame: Psychological evaluation at baseline, 3, 12, and 24 months ]
Same as current
Not Provided
Not Provided
 
Medical Treatment of "High-Risk" Neurofibromas
Medical Treatment of "High-Risk" Neurofibromas in Patients With Type 1 Neurofibromatosis: A Clinical Trial of Sequential Medical Therapies
Patients with neurofibromatosis type 1 (NF1) commonly develop non-cancerous tumors called plexiform neurofibromas. These tumors can be defined as "high-risk" when they result in severe pain, physical disability, organ dysfunction and/or become life-threatening. Presently, there is no effective medical therapy to offer patients with "high-risk" plexiform neurofibromas, and surgery does not provide lasting help. This study will evaluate the effectiveness of two treatment combinations in patients with "high-risk" plexiform neurofibromas.
The study's design involves treating eligible patients with a combination of celecoxib and pegylated interferon alpha-2b. If the patients have at least a partial response after six months, they may continue on the same treatment for up to two years. If the patient experiences less than a partial response, or has progressive disease after six months of therapy, then vincristine and temozolomide will be added to the celecoxib and interferon alpha-2b backbone. Response to treatment will be assessed after a minimum of six months, presuming the patient has not experienced progressive disease. Total duration of therapy on study is two years for any individual treatment plan.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neurofibromatosis 1
  • Drug: Peg-Interferon alpha-2b
    age and weight dependant
  • Drug: Celecoxib (Celebrex)
    age and weight dependant
  • Drug: Temozolomide (temodar)
    age and weight dependant
  • Drug: Vincristine Sulfate (Oncovin)
    age and weight dependant
Experimental: Open-Label Intervention
This is a phase II single arm study with sequential treatments available by response where all participants begin therapy with a combination of celecoxib and interferon alpha-2b (CI, treatment-1). Response to CI therapy will be assessed at six months by clinical and radiographic evaluations. Those patients who have achieved a partial response (improvement in pain, improvement in functioning, or ≥50% reduction in tumor size) or complete response (resolution of pain, and normalization of functioning with a ≥ 90% reduction in tumor size) will continue with the same CI therapy for up-to two years on study.
Interventions:
  • Drug: Peg-Interferon alpha-2b
  • Drug: Celecoxib (Celebrex)
  • Drug: Temozolomide (temodar)
  • Drug: Vincristine Sulfate (Oncovin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
20
December 2017
October 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • "High-Risk" Plexiform Neurofibromas associated with a diagnosis of NF1
  • 2-30 years old (minimum bodyweight of 10 kilograms)
  • Adequate renal function

Exclusion Criteria:

  • Previously untreated active optic glioma
  • History of any previous allergy to study medications
  • History of ischemic vascular disease
  • Pregnancy / Breast feeding
Sexes Eligible for Study: All
2 Years to 30 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00846430
2008-260
2008-260
No
Not Provided
Not Provided
Albert Cornelius, Spectrum Health Hospitals
Spectrum Health Hospitals
Not Provided
Principal Investigator: Albert S Cornelius, MD Helen DeVos Children's Hospital
Spectrum Health Hospitals
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP