Gimatecan in Treating Patients With Recurrent or Progressive Primary Malignant Glioma

NCT00087061 | Completed Phase 1

• 2 other identifiers: SIGMATAU-ST-01-402UCLA-0403029-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gimatecan, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase I/II trial is studying the side effects and best dose of gimatecan in treating patients with recurrent or progressive primary malignant glioma.

Conditions

Brain and Central Nervous System Tumors

Keywords

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

Interventions

gimatecan DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed malignant glioma (glioblastoma multiforme, anaplastic astrocytoma, or anaplastic oligodendroglioma) * Recurrent or progressive primary CNS neoplasm by contrast-enhanced MRI * Tumor progression after prior surgery, radiotherapy, or chemotherapy * Measurable or evaluable disease * Failed prior standard curative or palliative therapy (phase I only) PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count ≥ 2,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * SGPT and SGOT ≤ 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases are present) * Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if liver metastases are present) * Bilirubin normal Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * No myocardial infarction with the past year * No heart failure (including cardiac insufficiency controlled by digitalis and diuretics) * No irreversible arrhythmias requiring permanent medication * No uncontrolled hypertension Gastrointestinal * No gastrointestinal dysfunction that would alter absorption or motility, such as any of the following: * Active peptic ulcer * Inflammatory bowel disease * Known intolerance to lactose * Malabsorption syndromes * Intestinal sub-occlusion Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception * No active infection * No mentally incapacitated patients * No other concurrent severe disease that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy Chemotherapy * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) * No more than 1 prior chemotherapy regimen * No other concurrent chemotherapy Endocrine therapy * Concurrent corticosteroids allowed if dose stable for the past 2 weeks * No concurrent hormonal therapy Radiotherapy * See Disease Characteristics * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * See Disease Characteristics * At least 3 weeks since prior surgical resection * No prior gastrointestinal surgery that would affect drug absorption Other * More than 4 weeks since prior participation in any other investigational drug study * More than 72 hours since prior systemic antibiotics * No concurrent H2 antagonists, antacids, or proton pump inhibitors * If any of these therapies are necessary, ≥ 3 hours must elapse after gimatecan administration * No other concurrent anticancer therapy * No other concurrent investigational drugs * No other concurrent immunosuppressive agents

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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

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

Interventions

ST 1481

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Glioma; 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

• Timothy F. Cloughesy, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2004
• First Posted: July 12, 2004
• Study Start: May 1, 2004
• Study Completion: June 1, 2005
• Last Updated: July 18, 2013

Record last verified: 2005-05

Locations

US (1)