Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT00068367
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed malignant peripheral nerve sheath tumor
* Malignant schwannoma or neurofibrosarcoma
* Clinical evidence of unresectable or metastatic disease
* Measurable disease
* No known current CNS metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* SGOT or SGPT less than 1.5 times ULN (5 times ULN for patients with documented liver metastases)
Renal
* Creatinine no greater than 1.5 times ULN
* Creatinine clearance greater than 60 mL/min
Ophthalmic
* No known history of any of the following corneal diseases:
* Dry eye syndrome
* Sjögren's syndrome
* Keratoconjunctivitis sicca
* Exposure keratopathy
* Fuch's dystrophy
* No other active disorders of the cornea
Gastrointestinal
* No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
* No active peptic ulcer disease
* No intractable nausea or vomiting
* Able to swallow medications OR receive enteral medications via gastrostomy feeding tube
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 28 days since prior biologic therapy for this malignancy
Chemotherapy
* More than 28 days since prior chemotherapy for this malignancy
Endocrine therapy
* Not specified
Radiotherapy
* More than 60 days since prior radiotherapy to the target lesion with subsequent documented progression
* More than 60 days since prior radiofrequency ablation to the target lesion with subsequent documented progression
* No concurrent radiotherapy
Surgery
* At least 3 weeks since prior major surgery and recovered
* No prior surgical procedure affecting absorption
Other
* More than 28 days since prior investigational drugs for this malignancy
* More than 60 days since prior embolization to the target lesion with subsequent documented progression
* No prior epidermal growth factor receptor-targeting therapy
* No concurrent antiretroviral therapy for HIV-positive patients
* No other concurrent investigational or commercial agents or therapies for the malignancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00068367
Study Brief:
Protocol Section:
NCT00068367