Trial Search Results
Peginterferon Alfa-2b in Treating Younger Patients With Craniopharyngioma That is Recurrent or Cannot Be Removed By Surgery
This phase II trial studies how well peginterferon alfa-2b works in treating younger patients with craniopharyngioma that is recurrent or cannot be removed by surgery. Peginterferon alfa-2b may interfere with the growth of tumor cells and slow the growth of craniopharyngioma.
Stanford is currently not accepting patients for this trial.
Lead Sponsor:
Pediatric Brain Tumor Consortium
Collaborator: National Cancer Institute (NCI)
Stanford Investigator(s):
Intervention(s):
- Biological: peginterferon alfa-2b
- Other: laboratory biomarker analysis
Phase:
Phase 2
Eligibility
Inclusion Criteria:
- Patient must have a histologically verified diagnosis of craniopharyngioma
- Stratum 1: patients with progressive unresectable or recurrent craniopharyngiomas
treated with surgery alone, who have not received radiation therapy; patients
with unresectable craniopharyngiomas, (i.e. residual measurable disease following
surgical resection) will be enrolled at the time of progression
- Stratum 2: patients with progressive or recurrent craniopharyngiomas following
radiation therapy
- All patients must have measurable residual disease defined as tumor measurable in two
perpendicular diameters on magnetic resonance imaging (MRI)
- Please note: measurements are required for both the solid and cystic components
- Subjects must have recovered from the acute toxicities of all prior therapy before
entering this study; for those acute baseline adverse events attributable to prior
therapy, recovery is defined as a toxicity grade =< 2, using Common Terminology
Criterial for Adverse Events (CTCAE) version (v.) 4.0, unless otherwise specified in
the inclusion and exclusion criteria
- Myelosuppressive chemotherapy (includes intra-cystic bleomycin):
- Subjects must have received their last dose of known myelosuppressive anticancer
chemotherapy at least three (3) weeks prior to study registration or at least six
(6) weeks if nitrosourea
- Subjects must have received their last dose of investigational or biologic agent >= 7
days prior to study registration
- In the event that a subject has received an investigational or biologic agent and
has experienced >= grade 2 myelosuppression, then at least three (3) weeks must
have elapsed prior to registration
- If the investigational or biologic agent has a prolonged half-life (>= 7 days)
then at least three (3) weeks must have elapsed prior to registration
- Subjects must have completed at least 3 half-life periods from the last dose of
monoclonal antibody prior to registration
- Note: a list of half-lives of commonly used monoclonal antibodies is available on
the Pediatric Brain Tumor Consortium (PBTC) website under Generic Forms and
Templates
- Stratum 1: patients must not have received radiation therapy
- Stratum 2: patients must have received radiation therapy, including gamma knife or
phosphorus-32 (P32)
- More than 6 months from the time of enrollment if the recurrence is predominantly
solid
- More than 12 months from the time of enrollment if the recurrence is
predominantly cystic
- At least 7 days since the completion of therapy with a hematopoietic growth agent
(filgrastim, sargramostim, and erythropoietin) and 14 days for long-acting
formulations
- Karnofsky performance scale (KPS for > 16 years [yrs] of age) or Lansky performance
score (LPS for =< 16 years of age) >= 60 assessed within two weeks prior to
registration
- Age: 18 months - 25 years (Minimum weight 20 Kilogram is required to be eligible for
the study, since the minimum injection volume of SYLATRON is 0.05 ml, 20 mcg, SQ as
suggested by Merck)
- Absolute neutrophil count (ANC) >= 1000/ul (unsupported)
- Platelets >= 100,000/ul (unsupported)
- Hemoglobin (Hg) >= 8g/dL (unsupported)
- Alanine aminotransferase (ALT) =< 2.5 x the upper limit of institutional normal
- Total bilirubin =< x 1.5 upper limit of institutional normal
- Serum creatinine =< 1.5 x the upper limit of normal for age, or calculated creatinine
clearance or nuclear glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2
- =< 0.6 mg/dL (1 to < 2 years of age)
- =< 0.8 mg/dL (2 to < 6 years of age)
- =< 1.0 mg/dL (6 to < 10 years of age)
- =< 1.2 mg/dL (10 to < 13 years of age)
- =< 1.4 mg/dL (females >= 13 years of age)
- =< 1.5 mg/dL (males 13 to < 16 years of age)
- =< 1.7 mg/dL (males >= 16 years of age)
- All patients must have undergone at least one surgical procedure to verify the
diagnosis
- Patients must have evidence of radiographic progression as defined below:
- Stratum 1: defined as >= 25% increase in the product of the greatest
perpendicular diameters of the tumor as a whole (solid and cystic component) AND
>= 0.4 cm increase in each of at least two dimensions of the tumor as a whole OR
any new or worsening neurologic/vision deficit in conjunction with a lesser
change in the solid or cystic component
- Stratum 2:
- For patients more than 6 months following radiation therapy (RT) (including
radiosurgery or P32), progression is defined as a >= 25% increase in the
product of the greatest perpendicular diameters of the solid component AND
>= 0.4 cm increase in each of at least two dimensions of the solid component
- For patients more than 12 months following RT (including radiosurgery or
P32), progression is defined as >= 25% increase in each of the product of
the greatest perpendicular diameters of the solid tumor AND >= 0.4 cm
increase in each of at least two dimensions of the solid tumor; patients
demonstrating isolated cyst progression more than 12 months after RT must
show a continued increase in the cystic component on two serial MRI scans
performed at least 4 weeks apart OR re-accumulation of the cyst following
one or more cyst aspirations; patients with progressive neurologic signs
and/or symptoms associated with isolated cyst formation or progression are
eligible if the neurologic signs and/or symptoms do not improve within 4
weeks of cyst aspiration
- Female subjects of childbearing potential must not be pregnant or breast-feeding;
female subjects of childbearing potential must have a negative serum or urine
pregnancy test; (pregnancy test must be repeated within 72 hours prior to the start of
therapy)
- Subjects of childbearing or child fathering potential must be willing to use a
medically acceptable form of birth control, which includes abstinence, while being
treated on this study
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Stratum 1 patients: must not have had > 3 surgical debulking procedures/resections
- Patients may not have received prior interferon, either systemic or intra-cystic
- Patients must not have evidence of metastatic tumor
- Patients must not be on steroids other than for physiologic replacement
- Patients must not have a severe psychiatric illness, including major depression or any
previous suicide attempts
- Patients must not be on phenytoin, warfarin or methadone due to potential drug
interactions
- Patients must not have known hypersensitivity reactions, such as urticaria,
angioedema, bronchoconstriction, anaphylaxis, Steven-Johnson syndrome, and toxic
epidermal necrolysis to interferon alpha or any other products component
- Subjects with inability to return for follow-up visits or obtain follow-up studies
required to assess toxicity to therapy
Ages Eligible for Study
18 Months - 25 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061
Not Recruiting