Trials Sponsors Conditions Drugs Pricing

Conditions

Brain and Central Nervous System Tumors Cognitive/Functional Effects Long-term Effects Secondary to Cancer Therapy in Adults Long-term Effects Secondary to Cancer Therapy in Children Poor Performance Status Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

cognitive/functional effectspoor performance statuslong-term effects secondary to cancer therapy in adultslong-term effects secondary to cancer therapy in childrenadult tumors metastatic to brainunspecified adult solid tumor, protocol specificunspecified childhood solid tumor, protocol specific

Outcome Measures

Primary Outcomes (2)

Maximum tolerated dose and toxicity as assessed by NCI CTC v2.0 (Phase I) (Phase I closed to accrual as of 4/15/05)
Overall survival (Phase II)

Secondary Outcomes (2)

Neurocognitive deterioration as assessed by Mini-Mental Status Examination (Phase II)
Time to cognitive failure as assessed by Kaplan-Meier (Phase II)

Interventions

irinotecan hydrochlorideDrug

cognitive assessmentProcedure

management of therapy complicationsProcedure

Eligibility Criteria

Age1 Year - 120 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of brain metastasis from a histologically confirmed solid tumor, meeting the following criteria: * Must have histologic proof of original malignancy * No germ cell tumor metastasis * Biopsy-proven brain metastasis preferred when clinical history and radiographic findings are equivocal * At least 1 unidimensionally measurable lesion ≥ 50 mm by head contrast CT scan and/or brain MRI * Patients enrolled in the phase II portion of the study must meet the following Radiation Therapy Oncology Group Recursive Partitioning Analysis staging criteria for brain metastases: * Class II classification * Zubrod performance status 0-1 AND any of the following: * Age \> 65 years * Extracranial metastasis * Uncontrolled primary malignancy PATIENT CHARACTERISTICS: * Zubrod performance status 0-1 * Life expectancy ≥ 3 months * Able to participate in the Mini-Mental Status Examination * WBC ≥ 3,000/mm³ * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 1.5 mg/dL * AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) * Hemoglobin ≥ 9.0 g/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No concurrent medical disease that, in the investigator's opinion, would preclude study participation PRIOR CONCURRENT THERAPY: * More than 21 days since prior chemotherapy * No prior whole-brain radiotherapy * No prior DNA topoisomerase I drugs (e.g., irinotecan hydrochloride, topotecan hydrochloride) * At least 4 days since prior and no concurrent known CYP3A4 inducers, including any of the following: * Phenytoin * Carbamazepine * Phenobarbital * Hypericum perforatum (St. John's wort)

Sponsors & Collaborators

University of California, Davis
Otherlead

Study Sites (1)

University of California Davis Cancer Center

Sacramento, California, 95817, United States

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain Neoplasms

Interventions

IrinotecanMental Status and Dementia TestsRadiotherapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloids

Study Officials

Allan Y. Chen, MD, PhD
University of California, Davis
STUDY CHAIR

Enrollment

30 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Purpose: TREATMENT
Sponsor Type: OTHER

Study Record Dates

First Submitted

October 18, 2006

First Posted

October 19, 2006

Study Start

December 2002

Date type not reported

This date has not been verified as actual or estimated.

Irinotecan and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases From Solid Tumors

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations