Status:
COMPLETED
Study of PEG-Intron for Plexiform Neurofibromas
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Plexiform Neurofibroma
Eligibility:
All Genders
18-21 years
Phase:
PHASE2
Brief Summary
This study is for slow growing tumors called plexiform neurofibromas (PNF) which are a relatively common problem in people with neurofibromatosis type 1 (NF1). These tumors are benign but as they grow...
Detailed Description
PEG-Intron will be given every week through a small needle under the skin, in the same way that insulin is given to people with diabetes. Subjects will be taught to do this at home. As long as the tum...
Eligibility Criteria
Inclusion
- Age \> or equal to 18 months to 21 years
- Diagnosis Patients with NF1 and progressive, symptomatic or life-threatening plexiform neurofibromas which are not surgically resectable. Patients without biopsy-proof of plexiform must have at least one other diagnostic criteria for NF1: 6 or more cafe-au-lait spots, freckling in the axilla or groin, optic glioma, 2 or more Lisch nodules, distinctive bony lesion, first degree relative with NF1.
- Only eligible if complete tumor resection is not feasible, or if a patient with a surgical option refuses surgery.
- Patients may be treated on this trial without having received prior therapy. If patients have received prior therapy, they must have recovered from all toxic effects prior to entering this study.
- Must have life expectancy of at least 12 months and a performance score (Karnofsky or Lansky) of \> or equal to 50.
- Must have adequate liver, kidney and bone marrow function
Exclusion
- Clinically significant unrelated systemic illness.
- Received an investigational agent within the past 30 days.
- Evidence of active visual pathway glioma
- History of malignant peripheral nerve sheath tumor or ther cancer other than surgically cured non-melanoma skin cancer or cervical carcinoma in situ
- Ongoing radiation therapy, chemotherapy, hormonal therapy directed at the tumor, or immunotherapy.
- Inability to return for follow-up visits or obtain follow-up studies
- Severe cardiovascular disease
- Pre-existing sever psychiatric condition or history of psychiatric disorder requiring hospitalization or a history of suicidal ideation or attempt.
- Thyroid dysfunction not responsive to therapy.
- Uncontrolled diabetes mellitus
- History of seropositivity for HIV
- Subjects who are pregnant, lactating, or of reproductive potential and not practicing an effective means of contraception.
- Any medical condition requiring chronic systemic corticosteroids.
- Subjects who are known to be actively abusing alcohol or drugs.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00396019
Start Date
December 1 2006
End Date
April 1 2014
Last Update
November 6 2017
Active Locations (1)
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1
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224