Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002625
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
1999-11-01
Brief Title:
Topotecan and Radiation Therapy in Treating Patients With Solid Tumors or Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE I STUDY OF TOPOTECAN AND THORACIC RADIATION
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase I trial to study the effectiveness of topotecan and radiation therapy in treating patients who have solid tumors or lymphoma Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage cancer cells Combining chemotherapy with radiation therapy may kill more cancer cells
Detailed Description:
OBJECTIVES
I Define the maximum tolerated dose and safety profile of topotecan TOPO administered with daily high-dose thoracic radiotherapy to a total of 60 Gy in patients with solid tumor or lymphoma
II Assess the qualitative and quantitative nature of the toxic effects encountered in this treatment
III Estimate the tissue and tumor TOPO concentrations during radiotherapy by evaluating plasma TOPO levels
IV Evaluate using Western blot and immunohistochemical stain the effects of TOPOradiotherapy on topoisomerase I levels in peripheral blood lymphocytes PBL
V Determine whether TOPO induces apoptosis in PBL from this patient population
VI Examine tumor tissue pre- and post-treatment if available for topoisomerase I levels DNA damage topoisomerase IDNA complexes and apoptotic events
OUTLINE
Radiosensitization plus Radiotherapy Topotecan TOPO NSC-609699 plus external-beam irradiation using linear accelerators with photon energies between 4 and 10 MV electrons acceptable for the boost field
I Define the maximum tolerated dose and safety profile of topotecan TOPO administered with daily high-dose thoracic radiotherapy to a total of 60 Gy in patients with solid tumor or lymphoma
II Assess the qualitative and quantitative nature of the toxic effects encountered in this treatment
III Estimate the tissue and tumor TOPO concentrations during radiotherapy by evaluating plasma TOPO levels
IV Evaluate using Western blot and immunohistochemical stain the effects of TOPOradiotherapy on topoisomerase I levels in peripheral blood lymphocytes PBL
V Determine whether TOPO induces apoptosis in PBL from this patient population
VI Examine tumor tissue pre- and post-treatment if available for topoisomerase I levels DNA damage topoisomerase IDNA complexes and apoptotic events
OUTLINE
Radiosensitization plus Radiotherapy Topotecan TOPO NSC-609699 plus external-beam irradiation using linear accelerators with photon energies between 4 and 10 MV electrons acceptable for the boost field
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 |
|---|---|---|---|
| WCCC-CO-9492 | None | None | None |
| NCI-T94-0099C | None | None | None |
| CDR0000063990 | REGISTRY | PDQ Physician Data Query | None |