Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003443
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
1999-11-01
Brief Title:
Bryostatin 1 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Trial of Bryostatin-1 In Patients With Metastatic or Recurrent Squamos Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2013-06
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 bryostatin 1 in treating patients with metastatic or recurrent head and neck cancer
PURPOSE Phase II trial to study the effectiveness of bryostatin 1 in treating patients with metastatic or recurrent head and neck cancer
Detailed Description:
OBJECTIVES I Evaluate the antitumor activity of bryostatin 1 in chemotherapy naive patients with metastatic or recurrent head and neck squamous cell carcinoma not curable with surgery or radiation therapy II Evaluate the safety and toxicity of bryostatin 1 when administered in the prescribed schedule in this patient population III Assess cyclin dependent kinase 2 activity protein kinase C activity and apoptosis measurements in selected patients with tumors accessible for biopsy following bryostatin 1 therapy
OUTLINE Patients receive bryostatin 1 IV over 24 hours once weekly for three weeks followed by one week of rest Treatment is continued every 4 weeks in the absence of unacceptable toxicity or disease progression Patients with stable disease after two courses may continue treatment or stop treatment at the discretion of the treating physician
PROJECTED ACCRUAL There will be 14-25 patients accrued into this study over 1-2 years
OUTLINE Patients receive bryostatin 1 IV over 24 hours once weekly for three weeks followed by one week of rest Treatment is continued every 4 weeks in the absence of unacceptable toxicity or disease progression Patients with stable disease after two courses may continue treatment or stop treatment at the discretion of the treating physician
PROJECTED ACCRUAL There will be 14-25 patients accrued into this study over 1-2 years
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 |
|---|---|---|---|
| CDR0000066471 | REGISTRY | None | None |
| NCI-T97-0095 | Registry Identifier | PDQ Physician Data Query | None |