Alanosine in Treating Patients With Progressive or Recurrent Malignant Gliomas

NCT00075894 | Completed Phase 1

• 2 other identifiers: CDR0000349473NABTT-0303
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 5

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as alanosine, use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase I trial is studying the side effects and best dose of alanosine in treating patients with high-grade progressive or recurrent malignant gliomas.

Conditions

Brain and Central Nervous System Tumors

Keywords

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

Interventions

L-alanosine DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed malignant glioma of 1 of the following types: * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Glioblastoma multiforme * Progressive or recurrent disease after prior radiotherapy with or without chemotherapy * Low-grade glioma that progressed after prior radiotherapy with or without chemotherapy and is found to be high-grade glioma after biopsy allowed * No more than 2 prior treatment regimens * Measurable disease by CT scan or MRI * Documented absence of methylthioadenosine phosphorylase (MTAP) on fixed tumor specimens PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 mg/dL * Transaminases ≤ 4 times upper limit of normal Renal * Creatinine ≤ 1.5 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception before, during, and for 4 weeks after study participation * Mini mental state exam score of ≥ 15 * No psychological or sociological condition, addictive disorder, or family problem that would preclude study compliance * No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast * No concurrent serious infection or medical illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent prophylactic growth factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) Chemotherapy * See Disease Characteristics * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy * Must be maintained on a stable or lower corticosteroid regimen from the time of the baseline scan until the start of study treatment * No concurrent steroids as antiemetics Radiotherapy * See Disease Characteristics * At least 3 months since prior radiotherapy Surgery * Not specified Other * Recovered from prior therapy * More than 10 days since prior anticonvulsant drugs that induce hepatic metabolic enzymes * No other concurrent investigational agents

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (5)

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, 33612-9497, 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

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

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

Interventions

alanosine

Condition Hierarchy (Ancestors)

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

Study Officials

• Surasak Phuphanich, MD, FAAN

  Emory University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 9, 2004
• First Posted: January 13, 2004
• Study Start: March 1, 2004
• Last Updated: January 13, 2009

Record last verified: 2006-08

Locations

US (5)