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Alanosine in Treating Patients With Progressive or Recurrent Malignant Gliomas Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Alanosine in Treating Patients With Progressive or Recurrent Malignant Gliomas conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Alanosine in Treating Patients With Progressive or Recurrent Malignant Gliomas Clinical research trials and Alanosine in Treating Patients With Progressive or Recurrent Malignant Gliomas medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Alanosine in Treating Patients With Progressive or Recurrent Malignant Gliomas. Alanosine in Treating Patients With Progressive or Recurrent Malignant Gliomas Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Alanosine in Treating Patients With Progressive or Recurrent Malignant Gliomas clinical trial. Participants oftentimes recieve the finest healthcare available for their Alanosine in Treating Patients With Progressive or Recurrent Malignant Gliomas condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > Alanosine in Treating Patients With Progressive or Recurrent Malignant Gliomas  Alanosine in Treating Patients With Progressive or Recurrent Malignant Gliomas
Alanosine in Treating Patients With Progressive or Recurrent Malignant Gliomas
For Condition: adult glioblastoma multiforme,adult anaplastic astrocytoma,adult anaplastic oligodendroglioma,recurrent adult brain tumor
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Drugs used in chemotherapy, such as alanosine, use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of alanosine in treating patients who have high-gradeprogressive or recurrentmalignantgliomas.
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. - Determine the response rate in patients treated with this drug. - Determine the time to response, duration of response, and progression-free and overall survival in patients treated with this drug. - Determine the relative incidence of homozygous deletions of MTAP in patients treated with this drug. - Determine the safety and tolerability of this drug in these patients. OUTLINE: This is an open-label, nonrandomized, multicenter, dose-escalation study. Patients in the phase I portion of the study 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. - Phase II: Patients receive SDX-102 as in phase I at the MTD. Patients are followed at 1 week and then every 2 months thereafter. PROJECTED ACCRUAL: A total of 24-53 (6-18 for phase I and 18-35 for phase II) patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SurasakPhuphanich, Study Chair, Winship Cancer Institute of Emory University
Massachusetts General Hospital Cancer Center *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Alison O'Neill 617-726-2000
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1030
United States
Recruiting Edward Shaw 336-716-4647
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Steven Brem 813-979-3063
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231-2410
United States
Recruiting Larry Kleinberg 410-614-2597
Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Mark Rosenblum 313-916-1340
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Louis Nabors 205-934-1432
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting David Peereboom 216-445-6068
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Kevin Judy 215-662-7854
Additional Information:
Study ID Numbers: CDR0000349473; NABTT-0303
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075894
Other Adult Anaplastic Oligodendroglioma Studies:
1. Efaproxiral Plus Carmustine in Treating Patients With Progressive or Recurrent Malignant Glioma
2. PEG-Interferon alfa-2b With or Without Thalidomide in Treating Patients With Recurrent High-Grade Gliomas
3. O(6)-benzylguanine in Treating Patients With Malignant Glioma
4. Irinotecan Plus Carmustine in Treating Patients With Recurrent Primary Malignant Glioma
5. Temozolomide in Treating Patients With Recurrent Malignant Glioma
Related Studies:
Other adult anaplastic oligodendroglioma Clinical Trials
Other Alabama Clinical Trials
Other Birmingham Clinical Trials
Alanosine in Treating Patients With Progressive or Recurrent Malignant Gliomas
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