SU5416 in Treating Patients With Recurrent Astrocytoma or Mixed Glioma That Has Not Responded to Radiation Therapy

NCT00004868 | Completed Phase 1 FDA Drug

• 4 other identifiers: NABTC-9902CDR0000067527MSKCC-01045NCI-00-C-0173
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 12

Brief Summary

RATIONALE: SU5416 may stop the growth of astrocytoma or glioma by stopping blood flow to the tumor. PURPOSE: Phase I/II trial to study the effectiveness of SU5416 in treating patients who have recurrent astrocytoma or mixed glioma that has not responded to previous radiation therapy.

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumor; adult meningioma; adult glioblastoma; adult anaplastic astrocytoma; adult anaplastic oligodendroglioma; adult mixed glioma; adult grade III meningioma; adult giant cell glioblastoma; adult gliosarcoma

Interventions

semaxanib DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically proven supratentorial malignant primary glioma, including: * Glioblastoma multiforme * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Anaplastic mixed oligoastrocytoma * Malignant astrocytoma not otherwise specified * Benign or malignant meningiomas, including brain and spinal meningiomas * Patients with meningiomas are excluded from phase II portion of study * Must have shown unequivocal evidence of tumor recurrence or progression by CT scan or MRI * Must have failed prior radiotherapy * Must have prestudy contrast MRI or contrast CT scan of brain on stable steroid dose within the past 14 days * Must be on stable (unchanged) dose of steroids for at least 5 days before scans * Phase II: * Must have completed radiotherapy at least 2 months prior to enrollment PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * More than 8 weeks Hematopoietic: * WBC at least 2,300/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 8 g/dL (transfusion allowed) Hepatic: * SGOT less than 2.5 times upper limit of normal * Bilirubin normal * No significant active hepatic disease Renal: * Creatinine less than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min * No significant active renal disease Cardiovascular: * No uncompensated coronary artery disease on ECG or physical examination * No history of myocardial infarction or severe/unstable angina within the past 6 months * No deep venous or arterial thrombosis within the past 3 months Pulmonary: * No pulmonary embolism within the past 3 months Other: * Not pregnant or nursing * Fertile patients must use effective contraception during and for 2 months after study * No other serious concurrent illness * No significant active psychiatric disease * No diabetes mellitus with severe peripheral vascular disease * No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No serious active infection * No other concurrent disease that would obscure toxic effects or dangerously alter drug metabolism PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior biologic therapy (e.g., interferon) and recovered * No concurrent immunotherapy Chemotherapy: * Phase I: * No more than 2 prior chemotherapy regimens for recurrent disease * Phase II: * No more than 1 prior chemotherapy regimen for recurrent disease * At least 2 weeks since prior vincristine * At least 6 weeks since prior nitrosoureas * At least 3 weeks since prior procarbazine * Recovered from prior chemotherapy * No concurrent chemotherapy Endocrine therapy: * See Disease Characteristics * At least 3 weeks since prior endocrine therapy (e.g., tamoxifen) and recovered Radiotherapy: * See Disease Characteristics * No concurrent radiotherapy Surgery: * Recovered from prior surgery * Recent prior resection of recurrent or progressive tumor allowed Other: * No other concurrent investigational agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (12)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94143-0128, United States

Location

Neuro-Oncology Branch

Bethesda, Maryland, 20892, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0752, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213-3489, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Neoplasms; Meningioma; Glioblastoma; Astrocytoma; Oligodendroglioma; Glioma; Gliosarcoma

Interventions

Semaxinib

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial

Study Officials

• Howard A. Fine, MD

  NCI - Neuro-Oncology Branch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2000
• First Posted: May 23, 2003
• Study Start: March 24, 2000
• Primary Completion: September 15, 2004
• Study Completion: September 15, 2005
• Last Updated: June 27, 2018

Record last verified: 2018-06

Locations

US (12)