Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002557
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Patients With Advanced or Recurrent Mycosis Fungoides
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PROTOCOL FOR THE MANAGEMENT OF MYCOSIS FUNGOIDES AND THE SEZARY SYNDROME
Status:
UNKNOWN
Status Verified Date:
2000-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of etoposide with or without doxorubicin and methotrexate in treating patients who have mycosis fungoides
PURPOSE Phase II trial to study the effectiveness of etoposide with or without doxorubicin and methotrexate in treating patients who have mycosis fungoides
Detailed Description:
OBJECTIVES I Assess the response rate in patients with Stage IIIIV or recurrent mycosis fungoides or Sezary syndrome treated with oral etoposide with the addition of doxorubicin then methotrexate for poor responders II Assess changes in the hematologic and immunologic status of the tumor in these patients
OUTLINE Patients are treated sequentially on Regimens A B and C depending on response The following acronyms are used CF Leucovorin calcium NSC-3590 DOX Doxorubicin NSC-123127 MTX Methotrexate NSC-740 VP-16 Etoposide NSC-141540 Regimen A Single-Agent Chemotherapy VP-16 Regimen B 2-Drug Combination Chemotherapy VP-16DOX Regimen C 3-Drug Combination Chemotherapy VP-16DOXMTX
PROJECTED ACCRUAL Study duration will be at least 3 years with an anticipated accrual of 3 patientsyear
OUTLINE Patients are treated sequentially on Regimens A B and C depending on response The following acronyms are used CF Leucovorin calcium NSC-3590 DOX Doxorubicin NSC-123127 MTX Methotrexate NSC-740 VP-16 Etoposide NSC-141540 Regimen A Single-Agent Chemotherapy VP-16 Regimen B 2-Drug Combination Chemotherapy VP-16DOX Regimen C 3-Drug Combination Chemotherapy VP-16DOXMTX
PROJECTED ACCRUAL Study duration will be at least 3 years with an anticipated accrual of 3 patientsyear
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-F94-0015 | None | None | None |
| SAFR-CT-MF-2 | None | None | None |