Completed

A Phase I/II, Open-Label, Non-Randomized, Multicenter, Single Agent Study Of Intravenous SDX-102 For The Treatment Of Patients With MTAP-Deficient High Grade Recurrent Malignant Gliomas

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What is being tested

Data Collection

Who is being recruted

Glioma+9

+ Neoplasms

+ Neoplasms by Histologic Type

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2004

Actual date on which the first participant was enrolled.

OBJECTIVES: * Determine the maximum tolerated dose of alanosine (SDX-102) with or without enzyme-inducible antiepileptic drugs (EIAEDs) in patients with methylthioadenosine phosphorylase (MTAP)-deficient high-grade progressive or recurrent malignant gliomas. * Determine the pharmacokinetics of this drug administered concurrently with EIAEDs in these patients. OUTLINE: This is an open-label, nonrandomized, multicenter, dose-escalation study. Patients are stratified according to concurrent anticonvulsant drug use (drugs that induce hepatic metabolic enzymes vs drugs that cause modest or no induction of hepatic metabolic enzymes OR no anticonvulsant drug). Patients receive alanosine (SDX-102) IV continuously for 5 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SDX-102 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study therapy, patients are followed at 1 week and then every 2 months thereafter. PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.

Official TitleA Phase I/II, Open-Label, Non-Randomized, Multicenter, Single Agent Study Of Intravenous SDX-102 For The Treatment Of Patients With MTAP-Deficient High Grade Recurrent Malignant Gliomas 
NCT00075894
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

GliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNervous System DiseasesNervous System NeoplasmsCentral Nervous System NeoplasmsNeuroectodermal TumorsNeoplasms, Neuroepithelial

Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Suspended

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

Tampa, United StatesSee the location
Suspended

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, United States
Suspended

Massachusetts General Hospital Cancer Center

Boston, United States
Suspended

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, United States
Completed5 Study Centers