Clinical trial: Bevacizumab and Cediranib Maleate in Treating Patients With Metastatic or Unresectable Solid Tumor, Lymphoma, Intracranial Glioblastoma, Gliosarcoma or Anaplastic Astrocytoma (NCT00458731)

Eligibility criteria:
Inclusion Criteria:

          -  Patients must have histological confirmation of Solid Tumor or Lymphoma that is
             metastatic or unresectable; if assessing a single target lesion, histological
             confirmation of that particular lesion MUST be carried out

          -  Patients may have received an unlimited number of prior therapies; however, At least 4
             weeks MUST have passed since the last chemotherapy to day 1 of registration (6 weeks
             for regimens containing nitrosoureas or Mitomycin C)

          -  ECOG performance status =< 2 (Karnofsky >= 60%)

          -  Leukocytes >= 3,000/mcL

          -  Absolute neutrophil count >= 1,500/mcL

          -  Platelets >= 100,000/mcL

          -  Total bilirubin =< 2.0 mg/dL (does NOT apply to patients with Gilbert's Syndrome)

          -  AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal (Patients with liver
             involvement will be allowed =< 5.0 X institutional upper normal limit)

          -  Serum creatinine =< 2.0 mg/dL

          -  Patients MUST have recovered from all treatment related toxicities to Grade 1 NCI CTC
             (v 4.0) in severity

          -  Patients must be willing and able to review, understand, and provide written consent
             before starting therapy

          -  Patients with stable brain metastasis (stable disease on one MRI assessment at least 4
             weeks after completion of whole brain radiation, no evidence of progression on MRI
             assessment 4 weeks after stereotactic radiosurgery or complete surgical excision) will
             also be allowed to participate in this trial

          -  Patients with histologically proven intracranial glioblastoma, gliosarcoma or
             anaplastic astrocytoma will be eligible; patients must have shown unequivocal
             radiographic evidence for tumor progression by MRI scan; scan should be performed
             within 14 days prior to registration and on a steroid dose that has been stable for at
             least 5 days; if the steroid dose is increased between the date of imaging and
             registration, a new baseline MRI is required

        Exclusion Criteria:

          -  Patients with squamous non-small cell lung carcinoma

          -  Serious or non-healing wound, ulcer or bone fracture

          -  History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess
             within 28 days of day 1 of registration

          -  Invasive procedures defined as follows:

               -  Major surgical procedure, open biopsy or significant traumatic injury within 28
                  days prior to Day 1 registration

               -  Anticipation of need for major surgical procedures during the course of the study

               -  Core biopsy within 7 days prior to day 1 of therapy

          -  Patients may not be receiving any other investigational agents

          -  Patients with bleeding diathesis (clinical bleeding, prothrombin time >= 1.5 X upper
             institutional normal value, INR >= 1.5, activated partial thromboplastin time aPTT >=
             1.5 X upper institutional normal value), active gastric or duodenal ulcer

          -  Uncontrolled systemic vascular hypertension (Systolic blood pressure > 140 mmHg,
             Diastolic Blood Pressure > 90 mmHg)

          -  Urine protein should be screened by dipstick or urine analysis; for proteinuria > 1+
             or urine protein:creatinine ratio > 1.0, 24-hour urine protein should be obtained and
             the level should be < 1000 mg for patient enrollment

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection requiring parenteral antibiotics on Day 1

          -  Patients with clinically significant cardiovascular disease:

               -  History of CVA within 6 months

               -  Myocardial Infarction or unstable angina within 6 months

               -  New York Heart Association Grade II or greater congestive heart failure, serious
                  cardiac arrhythmia requiring medication, unstable angina pectoris

               -  Clinically significant peripheral vascular disease

               -  QTc prolongation > 500msec or other significant ECG abnormality noted within 14
                  days of registration

               -  Conditions requiring concurrent use of drugs or biologics with proarrythmic
                  potential; these drugs are prohibited during studies with AZD2171 (refer to
                  appendix V for a listing of these agents)

          -  Patients with history of hemoptysis

          -  Patients with tumor mass abutting a major vessel

          -  Pregnant women are excluded from this study because AZD-2171 is an angiogenesis
             inhibiting agent with potential teratogenic or abortifacient effects; because of the
             potential risk for adverse events in nursing infants secondary to treatment of the
             mother with AZD-2171, breastfeeding should be discontinued if the mother is treated
             with AZD-2171; these potential risks may also apply to other agents used in this
             study; women of child-bearing potential and men must agree to use contraception prior
             to study entry and for the duration of study participation; should a woman become
             pregnant or suspect she is pregnant while participating in this study, she should
             inform her treating physician immediately
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 15 Years old.


Patient description (medical language): A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable.

Patient description (patient's own words): I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine.

Does the patient match the trial criteria? 0