Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Harry T Whelan, MD
With
Pinnacle Biologics Inc.
Age
0–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Age: ≥ 6 months and \< 18 years
2. Disease: Patients with relapsed or refractory brain tumors are eligible. Patients must have had histologic verification of malignancy at original diagnosis or relapse. Tumors can be either supratentorial or infratentorial (posterior fossa) in location.
3. Disease Status: Patients must have potentially resectable disease.
4. Therapeutic Options: Patients' current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.
5. Performance Level: Karnofsky 50% or greater for patients \> 16 years of age and Lansky 50 or greater for patients \< 16 years of age. Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
6. Predictable Life Expectancy: \> 8 weeks
7. Prior Therapy: Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy. At least 3 weeks from previous chemotherapy and 4 weeks from prior radiation therapy
8. Organ Function:
Adequate bone marrow function
Absolute neutrophil count ≥ 1,000
Platelet count ≥ 100,000 (may transfuse to meet requirement)
Adequate renal function
Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m2 OR
A serum creatinine within normal range based on age/gender
Adequate liver function Bilirubin (direct) ≤ 3X upper limit of normal (ULN) for age
SGPT (ALT) ≤ 10X ULN
For the purpose of this study, the ULN for SGPT is 45 U/L
Serum albumin ≥ 2 g/dL
Adequate coagulation
PT and INR ≤ 2X ULN for age
9. Central Nervous System Function: Patients with seizure disorder may be enrolled if receiving non- enzyme inducing anticonvulsants and well controlled.
10. Informed Consent: All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
11. Archival tumor tissue slides from initial diagnosis should be reviewed by CHW institutional pathologists prior to study enrollment whenever possible.
You may not be if
1. Disseminated disease (metastatic disease)
2. Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study, as risks of fetal and teratogenic adverse effects of Photofrin® are not known.
