Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052442
Status:
COMPLETED
Last Update Posted:
2021-08-25
First Post:
2003-01-24
Brief Title:
10-Propargyl-10-Deazaaminopterin in Treating Patients With Recurrent or Refractory Non-Hodgkins Lymphoma or Hodgkins Lymphoma
Sponsor:
Spectrum Pharmaceuticals Inc
Organization:
Spectrum Pharmaceuticals Inc
Study Overview
Official Title:
A Phase II Study of 10-Propargyl-10-Deazaaminopterin PDX in Relapsed or Refractory Aggressive Non-Hodgkins Lymphomas and Hodgkins Disease
Status:
COMPLETED
Status Verified Date:
2021-08
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
PURPOSE Phase II trial to study the effectiveness of 10-propargyl-10-deazaaminopterin in treating patients who have recurrent or refractory non-Hodgkins lymphoma or Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of 10-propargyl-10-deazaaminopterin in treating patients who have recurrent or refractory non-Hodgkins lymphoma or Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the efficacy of 10-propargyl-10-deazaaminopterin in terms of objective response rate duration of response and time to disease progression in patients with relapsed or refractory aggressive non-Hodgkins lymphoma or Hodgkins lymphoma
Determine the impact of pharmacokinetics on toxicity and drug elimination in patients treated with this drug
Determine the toxicity of this drug in these patients
Determine the effect of prior chemotherapy response duration on duration of response in patients treated with this drug
Correlate if possible the pharmacodynamics area under the curve of this drug with tumor response and toxicity mucositis in these patients
Correlate if possible intraerythrocytic folate or homocysteine levels with severity of mucositis in patients treated with this drug
Determine whether levels of the RFC-1 folate transporter folylpolyglutamate synthetase and folylpolyglutamate hydrolase are markers of response in patients treated with this drug
OUTLINE This is an open-label study
Patients receive 10-propargyl-10-deazaaminopterin IV over 1 hour on day 1 Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR may receive 2 additional courses beyond the CR
PROJECTED ACCRUAL A total of 39-72 patients 12-35 for cohort 1 and 17-37 for cohort 2 will be accrued for this study within 10-36 months
Determine the efficacy of 10-propargyl-10-deazaaminopterin in terms of objective response rate duration of response and time to disease progression in patients with relapsed or refractory aggressive non-Hodgkins lymphoma or Hodgkins lymphoma
Determine the impact of pharmacokinetics on toxicity and drug elimination in patients treated with this drug
Determine the toxicity of this drug in these patients
Determine the effect of prior chemotherapy response duration on duration of response in patients treated with this drug
Correlate if possible the pharmacodynamics area under the curve of this drug with tumor response and toxicity mucositis in these patients
Correlate if possible intraerythrocytic folate or homocysteine levels with severity of mucositis in patients treated with this drug
Determine whether levels of the RFC-1 folate transporter folylpolyglutamate synthetase and folylpolyglutamate hydrolase are markers of response in patients treated with this drug
OUTLINE This is an open-label study
Patients receive 10-propargyl-10-deazaaminopterin IV over 1 hour on day 1 Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR may receive 2 additional courses beyond the CR
PROJECTED ACCRUAL A total of 39-72 patients 12-35 for cohort 1 and 17-37 for cohort 2 will be accrued for this study within 10-36 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-H02-0100 | None | None | None |
| MSKCC-02078 | None | None | None |