CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas

NCT00074243 | Completed Phase 1

• 2 other identifiers: CDR0000343702NCI-04-C-0035
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as CC-8490, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of CC-8490 in treating patients who have recurrent or refractory high-grade gliomas.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult anaplastic astrocytoma; adult anaplastic oligodendroglioma; adult glioblastoma; adult mixed glioma; adult brain stem glioma; recurrent adult brain tumor; adult giant cell glioblastoma; adult gliosarcoma

Interventions

CC-8490 DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed supratentorial malignant glioma, including any of the following: * Glioblastoma multiforme * Gliosarcoma * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Anaplastic mixed oligoastrocytoma * Malignant glioma/astrocytoma not otherwise specified OR * Clinical and radiographic diagnosis of progressive low-grade glioma * Radiographically diagnosed infiltrating brain stem gliomas not amenable to biopsy allowed * Recurrent or progressive disease as determined by 1 of the following: * CT scan or MRI within the past 21 days * Biopsy within the past 12 weeks * Failed prior radiotherapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * More than 8 weeks Hematopoietic * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 (transfusion independent) * Hemoglobin at least 8 g/dL (transfusion allowed) Hepatic * Bilirubin no greater than 1.5 mg/dL * AST and ALT no greater than 2 times upper limit of normal * No significant active hepatic disease that would preclude study participation Renal * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min * No significant active renal disease that would preclude study participation Cardiovascular * No significant active cardiac disease that would preclude study participation Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 months after study participation * No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No significant active psychiatric disease that would preclude study participation * No other condition or laboratory abnormality that would preclude study participation * Able to swallow capsules whole PRIOR CONCURRENT THERAPY: Biologic therapy * At least 2 weeks since prior interferon * No concurrent immunotherapy Chemotherapy * At least 2 weeks since prior vincristine * At least 3 weeks since prior procarbazine * At least 4 weeks since prior temozolomide or carboplatin * At least 6 weeks since prior nitrosoureas * No other concurrent anticancer chemotherapy Endocrine therapy * At least 2 weeks since prior tamoxifen * Concurrent steroids allowed provided dose has been stable for at least 5 days prior to study enrollment Radiotherapy * See Disease Characteristics * At least 2 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * At least 2 weeks since prior resection of a recurrent or progressive tumor Other * At least 2 weeks since other prior non-cytotoxic therapy * At least 4 weeks since other prior cytotoxic therapies * More than 28 days since prior experimental study drugs * 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

• National Cancer Institute (NCI): lead

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

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

Interventions

CC-8490

Condition Hierarchy (Ancestors)

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

Study Officials

• Howard A. Fine, MD

  NCI - Neuro-Oncology Branch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 10, 2003
• First Posted: December 11, 2003
• Study Start: December 1, 2003
• Last Updated: April 30, 2015

Record last verified: 2006-11

Locations

US (1)