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

NCT00389584 | Completed Phase 1 DMC

• 4 other identifiers: CDR0000506074UCDCC-132UCDCC-200210643-5PFIZER-Z1001692
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Irinotecan may make tumor cells more sensitive to radiation therapy. Giving irinotecan together with whole-brain radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of irinotecan when given together with whole-brain radiation therapy and to see how well they work in treating patients with brain metastases from solid tumors. (The study of side effects and best dose has ended as of 4/15/05)

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 effects; poor performance status; long-term effects secondary to cancer therapy in adults; long-term effects secondary to cancer therapy in children; adult tumors metastatic to brain; unspecified adult solid tumor, protocol specific; unspecified 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 hydrochloride DRUG

cognitive assessment PROCEDURE

management of therapy complications PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 1 Year - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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)

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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Neoplasms

Interventions

Irinotecan; Mental Status and Dementia Tests; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Therapeutics

Study Officials

• Allan Y. Chen, MD, PhD

  University of California, Davis

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: October 18, 2006
• First Posted: October 19, 2006
• Study Start: December 1, 2002
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: November 6, 2017

Record last verified: 2017-10

Locations

US (1)