SU5416 in Treating Children With Recurrent or Progressive Brain Tumors

This study has been terminated.
(The pharmaceutical company discontinued further development of SU5416.)
Sponsor:
Collaborator:
Information provided by:
Pediatric Brain Tumor Consortium
ClinicalTrials.gov Identifier:
NCT00006247
First received: September 11, 2000
Last updated: October 13, 2009
Last verified: October 2009
  Purpose

RATIONALE: SU5416 may stop the growth of brain cancer cells by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the safety of delivering SU5416 in children who have recurrent or progressive brain tumors.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: semaxanib
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: A Phase I Study of SU5416 in Pediatric Patients With Recurrent or Progressive Poor Prognosis Brain Tumors

Resource links provided by NLM:


Further study details as provided by Pediatric Brain Tumor Consortium:

Primary Outcome Measures:
  • Toxicities of SU5416 in children and adolescents with refractory CNS malignancies [ Designated as safety issue: Yes ]
  • Dose limiting toxicities of SU5416 in children and adolescents receiving enzyme inducing anticonvulsant drugs and in those not receiving enzyme inducing anticonvulsant drugs [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of SU5416 and the effects of enzyme inducing anticonvulsant drugs on the pharmacokinetics [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor response to SU5416 [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: August 2000
Study Completion Date: March 2006
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: semaxanib
    Other Name: SU5416
Detailed Description:

OBJECTIVES: I. Determine the qualitative and quantitative toxicity of SU5416 in pediatric patients with recurrent or progressive brain tumors. II. Determine the acute and chronic dose-limiting toxicity and cumulative toxicity of this regimen in these patients. III. Determine the maximum tolerated dose and pharmacokinetics of this regimen in this patient population. IV. Determine the effects of hepatic enzyme-inducing drugs, such as anticonvulsant agents, on the pharmacokinetics of this regimen in these patients. V. Determine the efficacy, in a preliminary manner, of this regimen in these patients.

OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to concurrent use of enzyme-inducing anticonvulsant drugs (yes vs no drugs or modest-induction drugs). Patients receive SU5416 IV over 1 hour twice a week for 6 weeks. Treatment repeats every 6 weeks for 17 courses (approximately 2 years) in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients in each stratum receive escalating doses of SU5416 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 50 patients (25 per stratum) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven malignant recurrent or progressive brain tumor at initial presentation or at time of recurrence or progression for which no standard curative therapy exists Histologic verification for brainstem gliomas may be waived Bone marrow involvement allowed

PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Karnofsky 60-100% Life expectancy: More than 8 weeks Hematopoietic: Absolute neutrophil count greater than 1,000/mm3* Platelet count greater than 75,000/mm3* Hemoglobin greater than 9 g/dL *Transfusion independent Hepatic: Bilirubin normal for age SGOT and SGPT less than 2.5 times normal for age PT/PTT no greater than 1.2 times upper limit of normal Albumin greater than 3 g/dL No overt hepatic disease Renal: Creatinine no greater than 1.5 times normal for age OR Glomerular filtration rate greater than 70 mL/min No overt renal disease Cardiovascular: No deep venous or arterial thrombosis within the past 3 months No history of myocardial infarction, severe or unstable angina, or severe peripheral vascular disease No overt cardiac disease No prior cerebral bleeds Pulmonary: No pulmonary embolism within the past 3 months No overt pulmonary disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known allergies to paclitaxel or other agent that uses Cremophor EL No uncontrolled infection Neurological deficits allowed if stable for at least 1 week prior to study Greater than 3rd percentile weight for height

PRIOR CONCURRENT THERAPY: Biologic therapy: More than 6 months since prior bone marrow transplantation More than 1 week since prior growth factor(s) Chemotherapy: At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy: Concurrent dexamethasone allowed if dose stable for at least 1 week prior to study Radiotherapy: More than 3 months since prior craniospinal irradiation greater than 24 Gy More than 3 months since prior total body irradiation More than 2 weeks since prior focal irradiation to symptomatic metastatic sites No prior stereotactic radiosurgery Concurrent total body irradiation allowed Surgery: See Radiotherapy Other: No other concurrent anticancer or experimental drug therapy Concurrent anticonvulsant drugs allowed

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006247

Locations
United States, California
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94143-0128
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Pediatric Brain Tumor Consortium
Investigators
Study Chair: Mark W. Kieran, MD, PhD Dana-Farber Cancer Institute
  More Information

Publications:
Responsible Party: James M. Boyett/PBTC Operations and Biostatistics Center Executive Director, Pediatric Brain Tumor Consortium
ClinicalTrials.gov Identifier: NCT00006247     History of Changes
Other Study ID Numbers: CDR0000068179, PBTC-002
Study First Received: September 11, 2000
Last Updated: October 13, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pediatric Brain Tumor Consortium:
childhood craniopharyngioma
childhood central nervous system germ cell tumor
childhood oligodendroglioma
childhood choroid plexus tumor
childhood grade I meningioma
childhood grade II meningioma
childhood grade III meningioma
recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
recurrent childhood medulloblastoma
recurrent childhood visual pathway and hypothalamic glioma
recurrent childhood ependymoma

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on October 29, 2014