Alanosine in Treating Patients With Progressive or Recurrent Malignant Gliomas
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ClinicalTrials.gov Identifier: NCT00075894 |
Recruitment Status
:
Completed
First Posted
: January 13, 2004
Last Update Posted
: January 13, 2009
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain and Central Nervous System Tumors | Drug: L-alanosine | Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 18 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | March 2004 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00075894
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
Tampa, Florida, United States, 33612-9497 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 | |
United States, Massachusetts | |
Massachusetts General Hospital Cancer Center | |
Boston, Massachusetts, United States, 02114 | |
United States, Michigan | |
Josephine Ford Cancer Center at Henry Ford Hospital | |
Detroit, Michigan, United States, 48202 | |
United States, North Carolina | |
Wake Forest University Comprehensive Cancer Center | |
Winston-Salem, North Carolina, United States, 27157-1096 |
Study Chair: | Surasak Phuphanich, MD, FAAN | Emory University |
ClinicalTrials.gov Identifier: | NCT00075894 History of Changes |
Other Study ID Numbers: |
CDR0000349473 NABTT-0303 |
First Posted: | January 13, 2004 Key Record Dates |
Last Update Posted: | January 13, 2009 |
Last Verified: | August 2006 |
Keywords provided by National Cancer Institute (NCI):
adult anaplastic oligodendroglioma adult anaplastic astrocytoma adult glioblastoma |
recurrent adult brain tumor adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
Glioma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Alanosine Antibiotics, Antineoplastic Antineoplastic Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action |