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Chemotherapy Followed by Radiation Therapy in Treating Patients With Malignant Glioma

This study has been completed.

Sponsors and Collaborators: NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00019071
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: cladribine
Procedure: chemotherapy
Procedure: radiation therapy
Phase I

MedlinePlus related topics:   Cancer   

Drug Information available for:   Cladribine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A PHASE I STUDY OF 2-CHLORODEOXYADENOSINE AND RADIATION FOR THE TREATMENT OF HIGH GRADE GLIOMA (CDX)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   March 1995

Detailed Description:

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).

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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

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)

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00019071

Locations
United States, Maryland
Radiation Oncology Branch    
      Bethesda, Maryland, United States, 20892

Sponsors and Collaborators
NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)

Investigators
Study Chair:     C. Norman Coleman, MD     NCI - Radiation Oncology Branch; ROB    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000064153, NCI-95-C-0092A, NCI-95-C-0092
First Received:   July 11, 2001
Last Updated:   October 18, 2008
ClinicalTrials.gov Identifier:   NCT00019071
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult glioblastoma  
adult anaplastic astrocytoma  
adult giant cell glioblastoma  
adult gliosarcoma  

Study placed in the following topic categories:
Cladribine
Glioblastoma
Astrocytoma
Glioma
Central Nervous System Neoplasms
Gliosarcoma
Nervous System Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 31, 2008




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