Participant flow

Peginterferon Alfa-2b in Younger Patients With Craniopharyngioma That is Recurrent or Cannot Be Removed By Surgery · Source last updated 2020-02-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Stratum 1 patients are those with progressive unresectable or recurrent craniopharyngiomas treated with surgery alone, who had not received radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.

   id

   FG000

   title

   Stratum 1

2. description

   Stratum 2 patients are those with patients with progressive or recurrent craniopharyngiomas following radiation therapy. Treatment consisted of Peginterferon alfa-2b (Sylatron) subcutaneously weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.

   id

   FG001

   title

   Stratum 2

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Ineligible after enrollment

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         5

      type

      Lack of Efficacy

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      To receive alternative therapy

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Enlargement of cyst requiring drainage

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Weight criteria not met

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         12

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         11

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Stratum 1 patients had progressive unresectable or recurrent craniopharyngiomas treated with surgery alone. Stratum 2 patients had progressive/recurrent craniopharyngiomas following radiation. 19 patients were enrolled (7 stratum 1, 12 stratum 2); one of the stratum 2 patients was ineligible leaving 18 eligible patients (7 stratum 1, 11 stratum 2).

recruitment Details

Patients 18 months to 25 years with histologically confirmed craniopharyngioma were enrolled at Pediatric Brain Tumor Consortium (PBTC) member institutions. The first patient was enrolled on 4/1/2014 and the last patient was enrolled on 11/20/2017. Accrual was halted early due to lack of efficacy in stratum 2 and slow accrual in stratum 1.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice