Clinical Trials Logo

Clinical Trial Summary

RATIONALE: ATN-161 may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving ATN-161 together with carboplatin may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of ATN-161 when given together with carboplatin and to see how well they work in treating patients with recurrent malignant glioma.


Clinical Trial Description

OBJECTIVES:

Primary

- Establish the safety of ATN-161 and carboplatin in patients with recurrent intracranial malignant glioma.

- Determine the maximum tolerated dose of ATN-161 when administered with carboplatin in these patients. (phase I)

- Determine the antitumor activity of ATN-161 when administered with carboplatin in these patients. (phase II)

Secondary

- Describe the effects of this regimen on potential biomarkers of activity, including functional imaging with brain perfusion scans and circulating endothelial progenitor cells.

- Obtain preliminary evidence of efficacy of this regimen in these patients. (phase I)

- Characterize the plasma concentrations of this regimen in these patients. (phase I)

OUTLINE: This is an open-label, phase I dose-escalation study of ATN-161 followed by a phase II study. Patients in the phase II portion of the study are stratified according to tumor type (glioblastoma multiforme vs anaplastic glioma).

- Phase I: Patients receive ATN-161 IV over 10 minutes 3 times weekly in weeks 1-6 and carboplatin IV over 20 minutes in week 3 during course 1. Beginning in course 2, patients receive carboplatin IV over 20 minutes in week 1 and ATN-161 IV over 10 minutes 3 times weekly in weeks 1-4. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of ATN-161 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity during the first 6 weeks of treatment.

- Phase II: Patients receive carboplatin IV in week 1 and ATN-161 IV, at the MTD determined in phase I, 3 times weekly in weeks 1-4. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection at baseline and then periodically during phase I course 1 for pharmacokinetic and pharmacodynamic analysis and at baseline and then periodically during study for biomarker (e.g., circulating endothelial progenitor cells) correlative studies.

After completion of study treatment, patients are followed for 28 days.

PROJECTED ACCRUAL: A total of 82 patients will be accrued for this study. ;


Study Design

Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00352313
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact
Status Completed
Phase Phase 1/Phase 2
Start date May 2006
Completion date January 2008

See also
  Status Clinical Trial Phase
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Completed NCT00006080 - Fenretinide in Treating Patients With Recurrent Malignant Glioma Phase 2
Recruiting NCT00887146 - Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma Phase 3
Suspended NCT00935090 - 3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer N/A
Completed NCT00621686 - Bevacizumab and Sorafenib in Treating Patients With Recurrent Glioblastoma Multiforme Phase 2
Terminated NCT00227032 - Erlotinib in Treating Patients With Progressive Glioblastoma Multiforme Phase 1
Completed NCT00112502 - Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme Phase 2
Terminated NCT00243022 - Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme Phase 2
Active, not recruiting NCT00278278 - Combination Chemotherapy and Radiation Therapy With or Without Methotrexate in Treating Young Patients With Newly Diagnosed Gliomas Phase 3
Active, not recruiting NCT00087815 - Hyperbaric Oxygen Therapy in Treating Patients With Radiation Necrosis of the Brain N/A
Completed NCT00416819 - Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Primary CNS Lymphoma N/A
Completed NCT00052286 - Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer N/A
Completed NCT00006093 - EMD 121974 in Treating Patients With Progressive or Recurrent Glioma Phase 1/Phase 2
Recruiting NCT00004129 - Phosphorus 32 in Treating Patients With Glioblastoma Multiforme Phase 1
Completed NCT00004212 - DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas Phase 1
Completed NCT00003417 - Computer Planned Radiation Therapy Plus Chemotherapy in Treating Patients With Glioblastoma Multiforme Phase 1/Phase 2
Completed NCT00003464 - Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme Phase 2
Completed NCT00003173 - High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors Phase 2
Completed NCT00003484 - Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors Phase 1
Completed NCT00003020 - LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases Phase 1