Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase I/II Study of Irinotecan and Whole Brain Radiation Therapy in Patients With Brain Metastases From Solid Tumors
Verified date | October 2017 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Radiation therapy uses high-energy x-rays to kill tumor cells. Irinotecan may make tumor
cells more sensitive to radiation therapy. Giving irinotecan together with whole-brain
radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of irinotecan when
given together with whole-brain radiation therapy and to see how well they work in treating
patients with brain metastases from solid tumors. (The study of side effects and best dose
has ended as of 4/15/05)
Status | Completed |
Enrollment | 30 |
Est. completion date | November 2006 |
Est. primary completion date | November 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 120 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Diagnosis of brain metastasis from a histologically confirmed solid tumor, meeting the following criteria: - Must have histologic proof of original malignancy - No germ cell tumor metastasis - Biopsy-proven brain metastasis preferred when clinical history and radiographic findings are equivocal - At least 1 unidimensionally measurable lesion = 50 mm by head contrast CT scan and/or brain MRI - Patients enrolled in the phase II portion of the study must meet the following Radiation Therapy Oncology Group Recursive Partitioning Analysis staging criteria for brain metastases: - Class II classification - Zubrod performance status 0-1 AND any of the following: - Age > 65 years - Extracranial metastasis - Uncontrolled primary malignancy PATIENT CHARACTERISTICS: - Zubrod performance status 0-1 - Life expectancy = 3 months - Able to participate in the Mini-Mental Status Examination - WBC = 3,000/mm³ - Absolute neutrophil count = 1,500/mm³ - Platelet count = 100,000/mm³ - Bilirubin = 1.5 mg/dL - AST = 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) - Hemoglobin = 9.0 g/dL - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No concurrent medical disease that, in the investigator's opinion, would preclude study participation PRIOR CONCURRENT THERAPY: - More than 21 days since prior chemotherapy - No prior whole-brain radiotherapy - No prior DNA topoisomerase I drugs (e.g., irinotecan hydrochloride, topotecan hydrochloride) - At least 4 days since prior and no concurrent known CYP3A4 inducers, including any of the following: - Phenytoin - Carbamazepine - Phenobarbital - Hypericum perforatum (St. John's wort) |
Country | Name | City | State |
---|---|---|---|
United States | University of California Davis Cancer Center | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose and toxicity as assessed by NCI CTC v2.0 (Phase I) (Phase I closed to accrual as of 4/15/05) | |||
Primary | Overall survival (Phase II) | |||
Secondary | Neurocognitive deterioration as assessed by Mini-Mental Status Examination (Phase II) | |||
Secondary | Time to cognitive failure as assessed by Kaplan-Meier (Phase II) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01828775 -
Palliative Care Intervention in Improving Quality of Life, Psychological Distress, and Communication in Patients With Solid Tumors Receiving Treatment
|
N/A | |
Terminated |
NCT01642342 -
Recombinant Albumin Fusion Protein sEphB4-HSA in Treating Patients With Metastatic or Recurrent Solid Tumors
|
Phase 1 | |
Completed |
NCT00002950 -
Topotecan Plus Sargramostim in Treating Patients With Advanced Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01705548 -
Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis
|
N/A | |
Completed |
NCT02146222 -
VEGFR/PDGFR Dual Kinase Inhibitor X-82 and Docetaxel in Treating Patients With Solid Tumors
|
Phase 1 | |
Terminated |
NCT01602627 -
Hsp90 Inhibitor AUY922 in Treating Older Patients With Advanced Solid Malignancies
|
Phase 1 | |
Completed |
NCT01191216 -
1-Methyl-D-Tryptophan and Docetaxel in Treating Patients With Metastatic Solid Tumors
|
Phase 1 | |
Recruiting |
NCT01137825 -
Registry of Older Patients With Cancer
|
||
Recruiting |
NCT00992303 -
Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy Participants
|
||
Suspended |
NCT00935090 -
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
|
N/A | |
Completed |
NCT00924651 -
Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy
|
Phase 3 | |
Completed |
NCT00949949 -
Everolimus, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable Solid Tumors Refractory to Standard Therapy
|
Phase 1 | |
Withdrawn |
NCT00937417 -
S0716 Vandetanib and Docetaxel in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT00710632 -
Screening to Predict Weight Loss in Patients With Cancer
|
N/A | |
Completed |
NCT00544596 -
R-(-)-Gossypol Acetic Acid, Cisplatin, and Etoposide in Treating Patients With Advanced Solid Tumors or Extensive Stage Small Cell Lung Cancer
|
Phase 1 | |
Completed |
NCT00573690 -
Sorafenib Combined With Cisplatin and Etoposide or Carboplatin and Pemetrexed in Treating Patients With Metastatic Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT00436735 -
Nelfinavir in Treating Patients With Metastatic, Refractory, or Recurrent Solid Tumors
|
Phase 1 | |
Completed |
NCT00352443 -
S0528 Lapatinib and Everolimus in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
|
Phase 1 | |
Completed |
NCT00128622 -
Denileukin Diftitox Followed by Vaccine Therapy in Treating Patients With Metastatic Cancer
|
Phase 1 | |
Completed |
NCT00126620 -
Sorafenib and Erlotinib in Treating Patients With Metastatic or Unresectable Solid Tumors
|
Phase 1 |