Procarbazine in Treating Patients With Recurrent Brain Tumor

NCT00004004 | Completed Phase 1

• 3 other identifiers: CDR0000067214NABTT-9901JHOC-NABTT-9901
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 10

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of procarbazine in treating patients who have progressive or recurrent astrocytoma, oligodendroglioma, or glioblastoma multiforme following treatment with radiation therapy.

Conditions

Brain and Central Nervous System Tumors

Keywords

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

Interventions

procarbazine hydrochloride DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically proven malignant glioma of one of the following types: * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Glioblastoma multiforme * Progressive or recurrent disease after radiotherapy with or without chemotherapy * Measurable disease by serial MR or CT PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Greater than 2 months Hematopoietic: * Absolute neutrophil count at least 1500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGPT/SGOT no greater than 4 times upper limit of normal Renal: * Creatinine no greater than 1.7 mg/dL Other: * No serious concurrent infection * No other illness that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent filgrastim (G-CSF) during the first course Chemotherapy: * See Disease Characteristics * No more than 1 prior chemotherapy regimen * At least 3 weeks since prior chemotherapy (at least 6 weeks since prior nitrosoureas) * No more than 2 prior courses of carmustine or lomustine and no greater than 460 mg/m2 or 220 mg/m2, respectively * No prior procarbazine Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 3 months since prior radiotherapy Surgery: * Prior surgery allowed Other: * Recovered from toxicity of prior therapy * At least 10 days since prior anticonvulsants for patients in Arm II * No concurrent investigational agents * No concurrent ethanol, ephedrine, isoproterenol, epinephrine, tricyclic antidepressants, paragyliline, narcotic analgesics, antihistamines, phenothiazines, hypotensives, or barbiturates * At least 14 days since prior antidepressants (e.g., SSRI and/or MAO inhibitor) * Must avoid foods high in tyramine (i.e., dark beer, wine, yogurt, cheese, bananas)

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

Sponsors & Collaborators

• New Approaches to Brain Tumor Therapy Consortium: lead
• National Cancer Institute (NCI): collaborator

Study Sites (10)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

Related Publications (1)

• He X, Batchelor TT, Grossman S, Supko JG; New Approaches to Brain Tumor Therapy (NABTT) CNS Consortium. Determination of procarbazine in human plasma by liquid chromatography with electrospray ionization mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2004 Jan 25;799(2):281-91. doi: 10.1016/j.jchromb.2003.10.061.

  PMID: 14670747 RESULT

MeSH Terms

Conditions

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

Interventions

Procarbazine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Stuart A. Grossman, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 20, 2003
• Study Start: July 1, 1999
• Study Completion: August 1, 2003
• Last Updated: June 21, 2013

Record last verified: 2007-05

Locations

US (10)