Clinical Trials Logo

Clinical Trial Summary

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)


Clinical Trial Description

OBJECTIVES:

Primary

- Determine the maximum tolerated dose of irinotecan hydrochloride administered concurrently with whole-brain radiotherapy in patients with brain metastases from solid tumors. (Phase I) (Phase I closed to accrual as of 4/15/05)

- Determine the toxicity of this regimen in these patients. (Phase I) (Phase I closed to accrual as of 4/15/05)

- Determine the overall survival of patients treated with this regimen. (Phase II)

Secondary

- Assess the neurocognitive function of these patients by Mini-Mental Status Examination. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of irinotecan hydrochloride (phase I closed to accrual as of 4/15/05) followed by a phase II study. Patients enrolled in phase II are stratified according to cognitive dysfunction (yes vs no).

- Phase I (closed to accrual as of 4/15/05): Patients undergo whole-brain radiotherapy (WBRT) once daily, 5 days a week, for 3 weeks (15 fractions). Patients also receive irinotecan hydrochloride IV over 90 minutes on days 1, 8, and 15.

Cohorts of 3-6 patients receive escalating doses of irinotecan hydrochloride until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

- Phase II (for patients enrolled after 4/15/05): Patients receive irinotecan hydrochloride at the MTD and undergo concurrent WBRT as in phase I.

Patients complete the Mini-Mental Status Examination to assess neurocognitive function at baseline, on the last day of radiotherapy, and periodically after completion of study therapy.

After completion of study therapy, patients are followed monthly for 3 months, at 6 months, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00389584
Study type Interventional
Source University of California, Davis
Contact
Status Completed
Phase Phase 1/Phase 2
Start date December 2002
Completion date November 2006

See also
  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
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
Suspended NCT00935090 - 3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer N/A
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 NCT00121277 - Vorinostat and Capecitabine in Treating Patients With Metastatic or Unresectable Solid Tumors Phase 1