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A PHASE I STUDY OF 2-CHLORODEOXYADENOSINE AND RADIATION FOR THE TREATMENT OF HIGH GRADE GLIOMA (CDX)


Phase 1
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

A PHASE I STUDY OF 2-CHLORODEOXYADENOSINE AND RADIATION FOR THE TREATMENT OF HIGH GRADE GLIOMA (CDX)


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

C. Norman Coleman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Radiation Oncology Branch; ROB

Authority:

United States: Federal Government

Study ID:

CDR0000064153

NCT ID:

NCT00019071

Start Date:

March 1995

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Glioma

Name

Location

Radiation Oncology BranchBethesda, Maryland  20892