Temozolomide in Treating Patients With Low-Grade Glioma

NCT00313729 | Completed Phase 2 Results DMC

• 4 other identifiers: CDR000044888399102BTRC-9902H7858-16278-07
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with supratentorial low-grade glioma.

Conditions

CNS Tumor, Adult

Keywords

adult oligodendroglioma; adult mixed glioma; adult diffuse astrocytoma; adult pilocytic astrocytoma; adult pineal gland astrocytoma

Outcome Measures

Primary Outcomes (1)

• Response Rate (Complete and Partial Response)

  Assessment of treatment response was determined by MRI in conjunction with neurological examination and steroid requirement assessment derived from Macdonald's criteria. Complete response was defined as complete disappearance of lesion on consecutive MRI scans with stable or improved neuro exam and steroids. Partial response was defined as a 50% reduction in lesion size or that tumor burden was "definitely better" than prior scan with stable or improved neuro exam and steroids.

  12 months

Secondary Outcomes (2)

• Time to Tumor Progression

  time from registration until date of the first documented progression, an average of 1 year

• Safety Profile

  Time from registration up to 13 months

Study Arms (1)

Temozolomide

EXPERIMENTAL

Temozolomide

Drug: temozolomide

Interventions

temozolomide DRUG

Chemotherapy

Also known as: Temodar

Temozolomide

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically proven supratentorial low-grade (grade II) glioma of any of the following histologic subtypes: * Oligodendroglioma * Astrocytoma * Oligoastrocytoma * Has undergone surgical resection or biopsy within 35 days after diagnosis of low-grade glioma * Study treatment must begin between 14 days and 4 months after surgical resection or biopsy * Evaluable disease by gadolinium-MRI PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL * Creatinine \< 1.5 times upper limit of normal (ULN) * BUN \< 1.5 times ULN * Bilirubin \< 1.5 times ULN * SGOT \< 2.5 times ULN * Alkaline phosphatase \< 2 times ULN * Life expectancy \> 12 weeks * No nonmalignant systemic disease resulting in the patient being a poor medical risk * No acute infection requiring intravenous antibiotics * No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction) * No other concurrent malignancies except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin * Prior malignancies must be in remission for ≥ 5 years * No known HIV positivity * No AIDS-related illness * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior radiotherapy, interstitial brachytherapy, or radiosurgery for low-grade glioma * No prior biological therapy or chemotherapy for low-grade glioma * No other concurrent chemotherapy * No concurrent radiotherapy or biological therapy * No concurrent prophylactic growth factors * No concurrent epoetin alfa * No other concurrent investigational drugs

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Oligodendroglioma; Glioma; Astrocytoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Susan Chang MD
• Organization: UCSF Neuro-Oncology

Susan.Chang@ucsf.edu

415-353-2966

Study Officials

• Susan M. Chang, MD

  University of California, San Francisco

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 11, 2006
• First Posted: April 12, 2006
• Study Start: May 1, 1999
• Primary Completion: September 25, 2014
• Study Completion: June 12, 2017
• Last Updated: February 7, 2019
• Results First Posted: January 23, 2019

Record last verified: 2019-01

Locations

US (1)