Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006477
Status:
COMPLETED
Last Update Posted:
2012-07-18
First Post:
2000-11-06
Brief Title:
Mistletoe Lectin in Treating Patients With Refractory Advanced Solid Tumors
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase I Clinical Trial of Recombinant Viscumin rVISCUMIN rMISTLETOE LECTIN rML Administered Twice Weekly by the Subcutanous Route in Patients With Solid Tumors After Failure of Standard Therapy
Status:
COMPLETED
Status Verified Date:
2012-07
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 Mistletoe lectin may slow the growth of cancer cells and be an effective treatment for solid tumors
PURPOSE Phase I trial to study the effectiveness of mistletoe lectin in treating patients who have refractory advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of mistletoe lectin in treating patients who have refractory advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and dose-limiting toxicity of mistletoe lectin recombinant viscumin in patients with advanced solid tumors who have failed standard therapy
Determine the optimal biologically active dose of mistletoe lectin based on analysis of specific biological surrogate markers including plasma cytokine levels and peripheral counts of activated immune cells and immunological stimulation at the RNA level of the immune cells
Determine the pharmacokinetics of this regimen in these patients
Determine whether induction of antibodies against mistletoe lectin occurs in these patients
Determine whether modification of endothelial parameters occurs in patients treated with this regimen
Determine the objective response rates in patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study
Patients receive mistletoe lectin recombinant viscumin subcutaneously twice weekly Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 patients receive escalating doses of mistletoe lectin until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Additional patients are treated at the highest dose level immediately preceding the MTD
Patients are followed every 3 months until disease progression or initiation of another therapy
PROJECTED ACCRUAL A maximum of 25 patients will be accrued for this study
Determine the maximum tolerated dose and dose-limiting toxicity of mistletoe lectin recombinant viscumin in patients with advanced solid tumors who have failed standard therapy
Determine the optimal biologically active dose of mistletoe lectin based on analysis of specific biological surrogate markers including plasma cytokine levels and peripheral counts of activated immune cells and immunological stimulation at the RNA level of the immune cells
Determine the pharmacokinetics of this regimen in these patients
Determine whether induction of antibodies against mistletoe lectin occurs in these patients
Determine whether modification of endothelial parameters occurs in patients treated with this regimen
Determine the objective response rates in patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study
Patients receive mistletoe lectin recombinant viscumin subcutaneously twice weekly Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 patients receive escalating doses of mistletoe lectin until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Additional patients are treated at the highest dose level immediately preceding the MTD
Patients are followed every 3 months until disease progression or initiation of another therapy
PROJECTED ACCRUAL A maximum of 25 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 |
|---|---|---|---|
| EORTC-13001 | None | None | None |