Paclitaxel Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma

NCT00031577 | Terminated Phase 1

• 5 other identifiers: 1999-6-1780CHP-623BMS-CHP-623NCI-V01-1677CDR0000069064
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Paclitaxel may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I trial to study the effectiveness of combining paclitaxel with radiation therapy in treating children who have newly diagnosed brain stem glioma.

Conditions

Brain and Central Nervous System Tumors

Keywords

untreated childhood brain stem glioma

Interventions

paclitaxel DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Newly diagnosed, diffuse, intrinsic brain stem glioma by clinical examination and magnetic resonance imaging (MRI) * Histologic verification not required * Intrinsic (more than 50% intra-axial) involvement of the pons, pons and medulla, pons and midbrain, or entire brain stem allowed * Contiguous involvement of the thalamus or upper cervical cord allowed PATIENT CHARACTERISTICS: Age: * 3 to 21 at diagnosis Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1,000/mm3 * Platelet count greater than 100,000/mm3 * Hemoglobin greater than 10.0 g/dL Hepatic: * Bilirubin less than 1.5 times normal * serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) less than 2.5 times normal Renal: * Creatinine less than 1.5 times normal Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use a highly effective method of contraception for female patients or barrier contraception for male patients PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No other concurrent anticancer chemotherapy Endocrine therapy: * Concurrent corticosteroid therapy for increased intracranial pressure allowed Radiotherapy: * Not specified Surgery: * Not specified Other: * No concurrent cytochrome P450-inducing anticonvulsants (e.g., phenytoin or carbamazepine) during paclitaxel therapy * Other concurrent anticonvulsants (e.g., valproic acid) for pre-existing seizure disorder allowed

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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (2)

Winship Cancer Institute of Emory University

Egleston, Georgia, 30322, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

Paclitaxel; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Therapeutics

Study Officials

• Jean B. Belasco, MD

  Children's Hospital of Philadelphia

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 8, 2002
• First Posted: January 27, 2003
• Study Start: August 1, 1999
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: March 19, 2015

Record last verified: 2014-01

Locations

US (2)