Search Clinical Trials
 
By Condition
 
By Location (USA)
 
By Location (Other)
 
By Sponsor
 
Resources
 
Privacy Policy
 
About Us
Disclaimer
Chemotherapy Followed by Radiation Therapy in Treating Patients With Malignant Glioma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Chemotherapy Followed by Radiation Therapy in Treating Patients With Malignant Glioma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Chemotherapy Followed by Radiation Therapy in Treating Patients With Malignant Glioma Clinical research trials and Chemotherapy Followed by Radiation Therapy in Treating Patients With Malignant Glioma healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Chemotherapy Followed by Radiation Therapy in Treating Patients With Malignant Glioma. Chemotherapy Followed by Radiation Therapy in Treating Patients With Malignant Glioma Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Chemotherapy Followed by Radiation Therapy in Treating Patients With Malignant Glioma clinical trial. Test subjects typically receive the most effective healthcare possible for their Chemotherapy Followed by Radiation Therapy in Treating Patients With Malignant Glioma condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.

Home > "C" Clinical Trials Conditions > Chemotherapy Followed by Radiation Therapy in Treating Patients With Malignant Glioma

Chemotherapy Followed by Radiation Therapy in Treating Patients With Malignant Glioma



Chemotherapy Followed by Radiation Therapy in Treating Patients With Malignant Glioma

For Condition: adult glioblastoma multiforme,adult anaplastic astrocytoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of cladribine followed by radiation therapy in treating patients who have malignant glioma.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of cladribine in combination with radiotherapy in patients with high grade glioma. II. Assess this regimen in terms of toxicity and survival in these patients. III. Assess the acute neurotoxicity of continuous infusion cladribine in these patients. IV. Assess this regimen in terms of response, local control, and time to progression in these patients. V. Define a dose level of cladribine associated with potentiation of acute and/or delayed radiation toxicity (radiosensitizing dose level). PROTOCOL OUTLINE: This is a dose escalation study of cladribine. Patients receive cladribine by continuous IV infusion 5 days a week for 4 weeks and undergo radiotherapy twice a day, beginning 3 hours after initiation of cladribine, 5 days a week for 4.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of cladribine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed at 1 month, then every 3 months thereafter for survival. PROJECTED ACCRUAL: A total of 12-42 patients will be accrued for this study within 18 months.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven high-grade glioma confined to 1 or both hemispheres of the brain and including: Grade III astrocytoma (anaplastic astrocytoma); Grade IV astrocytoma (glioblastoma multiforme) ineligible for NCI-95-C-0069 protocol - Histologic confirmation of high-grade astrocytoma by NIH neuropathology division required (including mandatory review of slides from biopsy or resection) - No evidence of metastatic or leptomeningeal spread --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No systemic chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior cranial radiotherapy - Surgery: No more than 3 months since surgery (biopsy; subtotal or near-total resection) --Patient Characteristics-- - Age: Over 18 - Performance status: Karnofsky 60-100%; ECOG 0-2 - Life expectancy: Greater than 6 months - Hematopoietic: WBC at least 3,500/mm3; Absolute granulocyte count at least 900/mm3; Absolute leukocyte count at least 900/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 10 g/dL - Hepatic: Liver function tests no greater than 2.5 times upper limit of normal - Renal: Creatinine clearance at least 95 mL/min; Creatinine no greater than 1.3 mg/dL - Other: No history of psychiatric disease that would prevent compliance; No other malignancy within the past 5 years except: Basal cell carcinoma of the skin; Carcinoma in situ of the cervix; Not pregnant
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
BrianFuller,  Study Chair,  National Cancer Institute (NCI)

Radiation Oncology Branch
Bethesda,  Maryland,  20892
United States
 


Additional Information:
Study ID Numbers:  CDR0000064153;  NCI-95-C-0092A,NCI-95-C-0092
Study Start Date: March 1995
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00019071

Other Adult Anaplastic Astrocytoma Studies:
1. Suramin in Treating Patients With Recurrent Primary Brain Tumors

2. Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma

3. Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma

4. Gefitinib Plus Temozolomide in Treating Patients With Malignant Primary Glioma

5. Temozolomide and Carmustine in Treating Patients With Anaplastic Glioma

Related Studies:

Other adult anaplastic astrocytoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials

Chemotherapy Followed by Radiation Therapy in Treating Patients With Malignant Glioma
Modify your Search

  Other adult anaplastic astrocytoma Clinical Trials
  Other Maryland Clinical Trials
  Other Bethesda Clinical Trials


Warning: include(/var/www/cgi-bin/traxis/counter.php) [function.include]: failed to open stream: No such file or directory in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103

Warning: include() [function.include]: Failed opening '/var/www/cgi-bin/traxis/counter.php' for inclusion (include_path='.:/usr/local/lib/php') in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103