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| ID | Type | Description | Link |
|---|---|---|---|
| THERADEX-100389 | |||
| BAYER-100389 | |||
| SUNY-HSC-4553 |
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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have refractory non-Hodgkin's lymphoma.
OBJECTIVES:
OUTLINE: This is a multicenter, open-label study.
Patients receive BAY 59-8862 IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months thereafter for up to 2 years.
PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ortataxel | Drug |
DISEASE CHARACTERISTICS:
Histologically confirmed aggressive refractory non-Hodgkin's lymphoma (NHL) of one of the following classifications, and for which chemotherapy is deemed appropriate:
Failed at least 1 prior therapy (primary resistant) OR
Previously achieved a remission and then progressed or relapsed within 6 months of therapy
At least 1 bidimensionally measurable lesion
No relapse within 6 months after prior autologous bone marrow transplantation
No prior allogeneic bone marrow or stem cell transplantation or post-transplant lymphoproliferative disorder
No parenchymal or meningeal CNS involvement unless the patient received prior definitive therapy more than 6 months ago, has had a negative imaging study within the past 4 weeks, and is clinically stable with respect to the tumor at study entry
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
No prior hypersensitivity to taxane compounds
No known or suspected allergy to the investigational study agent or any agent given in association with this study
No other prior or concurrent malignancy except basal cell skin cancer or curatively treated carcinoma in situ of the bladder or cervix (adequately cone biopsied)
No substance abuse or medical, psychological, or social conditions that would preclude study participation
No active clinically serious infections
No other condition that is unstable or would preclude study participation
No grade 2 or greater pre-existing peripheral neuropathy
No history of seizure disorder
HIV negative
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
See Disease Characteristics
At least 4 weeks since prior anticancer chemotherapy
No more than 3 prior systemic chemotherapy regimens for metastatic NHL:
No prior taxanes or oxaliplatin
No other concurrent anticancer chemotherapy
Endocrine therapy:
Patients with prior parenchymal or meningeal CNS involvement:
Radiotherapy:
See Disease Characteristics
At least 4 weeks since prior radiotherapy
Concurrent palliative radiotherapy allowed provided:
No other concurrent radiotherapy
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Rasim Ahmet Gucalp, MD | Montefiore Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | United States | ||
| University of Chicago Cancer Research Center |
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| Chicago |
| Illinois |
| 60637-1470 |
| United States |
| Veterans Affairs Medical Center - Shreveport | Shreveport | Louisiana | 71101 | United States |
| Louisiana State University Health Sciences Center - Shreveport | Shreveport | Louisiana | 71130-3932 | United States |
| Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| HemOnCare, P.C. | Brooklyn | New York | 11235 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| State University of New York - Upstate Medical University | Syracuse | New York | 13210 | United States |
| Albert Einstein Clinical Cancer Center | The Bronx | New York | 10461 | United States |
| New York Medical College | Valhalla | New York | 10595 | United States |
| West Clinic | Memphis | Tennessee | 38120 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226-3596 | United States |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| St. Paul's Hospital - Vancouver | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008224 | Lymphoma, Follicular |
| D008228 | Lymphoma, Non-Hodgkin |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D002051 | Burkitt Lymphoma |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
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| ID | Term |
|---|---|
| C404743 | IDN 5109 |
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