Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004258
Status:
COMPLETED
Last Update Posted:
2014-09-17
First Post:
2000-01-28
Brief Title:
EMD 121974 in Treating Patients With Locally Advanced or Metastatic Cancer
Sponsor:
Indiana University School of Medicine
Organization:
Indiana University
Study Overview
Official Title:
A Phase I Trial of EMD 121974 in Patients With Advanced or Metastatic Cancer
Status:
COMPLETED
Status Verified Date:
2014-09
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 EMD 121974 may stop the growth of cancer by stopping blood flow to the tumor
PURPOSE Phase I trial to study the effectiveness of EMD 121974 in treating patients who have locally advanced or metastatic cancer
PURPOSE Phase I trial to study the effectiveness of EMD 121974 in treating patients who have locally advanced or metastatic cancer
Detailed Description:
OBJECTIVES I Determine the safety and tolerability of EMD 121974 in patients with advanced or metastatic cancer II Correlate various surrogate markers of antiangiogenic activity with EMD 121974 therapy including magnetic resonance imaging and PET scans serum assays for various angiogenic and antiangiogenic factors serum and urine markers of calcium metabolism and tumor biopsies
OUTLINE This is a dose-escalation study Patients receive EMD 121974 IV over 1 hour twice weekly for 4 weeks Treatment continues for an additional course in the absence of unacceptable toxicity Patients with stable or responding disease may continue therapy indefinitely past the 2 courses until disease progression Cohorts of 3-6 patients receive escalating doses of EMD 121974 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 toxicities Patients are followed every 3 months for the first year and then every 4 months thereafter until disease progression
PROJECTED ACCRUAL A total of 31-40 patients will be accrued for this study
OUTLINE This is a dose-escalation study Patients receive EMD 121974 IV over 1 hour twice weekly for 4 weeks Treatment continues for an additional course in the absence of unacceptable toxicity Patients with stable or responding disease may continue therapy indefinitely past the 2 courses until disease progression Cohorts of 3-6 patients receive escalating doses of EMD 121974 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 toxicities Patients are followed every 3 months for the first year and then every 4 months thereafter until disease progression
PROJECTED ACCRUAL A total of 31-40 patients will be accrued for this study
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-T99-0076 | None | None | None |
| IUMC-9909-40 | None | None | None |