Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019071
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2001-07-11
Brief Title:
Chemotherapy Followed by Radiation Therapy in Treating Patients With Malignant Glioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A PHASE I STUDY OF 2-CHLORODEOXYADENOSINE AND RADIATION FOR THE TREATMENT OF HIGH GRADE GLIOMA CDX
Status:
COMPLETED
Status Verified Date:
2002-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE Phase I trial to study the effectiveness of cladribine followed by radiation therapy in treating patients who have malignant glioma
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 andor 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 45 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
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 45 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-95-C-0092 | None | None | None |
| NCI-95-C-0092A | None | None | None |