Peginterferon Alfa-2b in Younger Patients With Craniopharyngioma That is Recurrent or Cannot Be Removed By Surgery

NCT01964300 | Terminated Phase 2 Results DMC

• 3 other identifiers: PBTC-039NCI-2013-01639U01CA081457
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Childhood Craniopharyngioma

Outcome Measures

Primary Outcomes (2)

• Rate of Disease Stabilization at 1 Year (i.e., 9 Courses of Treatment) (for Stratum 1 Patients Only)

  The percentage of stratum 1 patients with disease stabilization at 1 year is reported, along with a 95% exact confidence interval for the estimate of the true 1-year disease stabilization rate.

  Up to 1 year

• Sustained Objective Response (PR+CR) Rate Observed During the First Year of Treatment (for Stratum 2 Patients Only)

  Objective responses had to be sustained for 3 months. The percentage of participants with sustained objective responses is reported with an exact 95% confidence interval of the true sustained objective response rate.

  Up to 1 year

Secondary Outcomes (2)

• Sustained Objective Response (PR+CR) Rate Observed During the First Year of Treatment (for Stratum 1 Patients Only)

  Up to 1 year

• Progression-free Survival (PFS)

  2 years after treatment start

Study Arms (1)

Treatment (peginterferon alfa-2b)

EXPERIMENTAL

Patients receive peginterferon alfa-2b subcutaneously (SC) weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.

Biological: peginterferon alfa-2b; Other: laboratory biomarker analysis

Interventions

peginterferon alfa-2b BIOLOGICAL

Given subcutaneously (SC)

Treatment (peginterferon alfa-2b)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (peginterferon alfa-2b)

Eligibility Criteria

• Age: 18 Months - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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, subcutaneously (SQ) as suggested by Merck)
• Absolute neutrophil count (ANC) \>= 1000/ul (unsupported)

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Pediatric Brain Tumor Consortium: lead

Study Sites (9)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Stanford University and Lucile Packard Children Hospital

Palo Alto, California, 94304, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Lurie Children's Hospital

Chicago, Illinois, 60614, United States

Location

National Cancer Institute Pediatric Oncology Branch

Bethesda, Maryland, 20892, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Children Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

St. Jude Children Research Hospital

Memphis, Tennessee, 38105, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

peginterferon alfa-2b

Results Point of Contact

• Title: Catherine Billups
• Organization: Pediatric Brain Tumor Consortium

catherine.billups@stjude.org

901-595-3709

Study Officials

• Stewart Goldman

  Ann & Robert H. Lurie Children Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: October 17, 2013
• Study Start: April 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: February 24, 2020
• Results First Posted: February 24, 2020

Record last verified: 2020-02

Locations

US (9)