Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002779
Status:
COMPLETED
Last Update Posted:
2016-12-15
First Post:
1999-11-01
Brief Title:
Fludarabine Plus Octreotide in Treating Patients With Relapsed Low-Grade Non-Hodgkins Lymphoma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
PHASE II TRIAL OF FLUDARABINE AND SANDOSTATIN FOR RELAPSED LOW-GRADE NON-HODGKINS LYMPHOMA
Status:
COMPLETED
Status Verified Date:
2016-12
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 and hormone therapy use different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of fludarabine plus octreotide in treating patients who have relapsed low-grade non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of fludarabine plus octreotide in treating patients who have relapsed low-grade non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the response rate and duration of response to fludarabine combined with octreotide and to octreotide alone in patients with relapsed indolent non-Hodgkins lymphoma II Determine serum insulin-like growth factor-1 IGF-1 and IGF-1 binding protein levels before and after treatment in this patient population III Determine somatostatin receptor subtypes in lymphoma biopsy samples from selected patients
OUTLINE Patients receive fludarabine IV over 10-30 minutes on days 1-5 Patients not currently receiving octreotide receive a test dose of octreotide subcutaneously on day 1 during course 1 only and then receive octreotide intramuscularly monthly on day 1 Treatment repeats every 28 days for 4-6 courses Patients then receive octreotide alone for 6-8 courses Some patients may then receive another 12 courses of octreotide alone for a total of 2 years of treatment Patients are followed every 3 months for 5 years or until disease progression
OUTLINE Patients receive fludarabine IV over 10-30 minutes on days 1-5 Patients not currently receiving octreotide receive a test dose of octreotide subcutaneously on day 1 during course 1 only and then receive octreotide intramuscularly monthly on day 1 Treatment repeats every 28 days for 4-6 courses Patients then receive octreotide alone for 6-8 courses Some patients may then receive another 12 courses of octreotide alone for a total of 2 years of treatment Patients are followed every 3 months for 5 years or until disease progression
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 |
|---|---|---|---|
| CDR0000064787 | REGISTRY | NCI Physician Data Query | None |
| NCCTG-947851 | None | None | None |