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Alanosine in Treating Patients With Progressive or Recurrent Malignant Gliomas

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00075894
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

National Cancer Institute (NCI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Surasak Phuphanich, MD, FAAN
Principal Investigator Affiliation Emory University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain and Central Nervous System Tumors
Additional Details

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.#46;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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Tampa, Florida

Status

Address

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

Tampa, Florida, 33612-9497

Baltimore, Maryland

Status

Address

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410

Boston, Massachusetts

Status

Address

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

Detroit, Michigan

Status

Address

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202

Winston-Salem, North Carolina

Status

Address

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096