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| ID | Type | Description | Link |
|---|---|---|---|
| ID99-406 | |||
| CDR0000068297 | Registry Identifier | PDQ (Physician Data Query) |
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Phase II trial to study the effectiveness of oxaliplatin in treating patients who have relapsed or refractory non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
OBJECTIVES:
I. Determine the response rate to oxaliplatin in patients with relapsed or refractory non-Hodgkin's lymphoma.
II. Determine the treatment-related toxicity of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to histologic subtype (indolent vs aggressive).
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A maximum of 72 patients will be accrued for this study within 2-3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (oxaliplatin) | Experimental | Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxaliplatin | Drug | Given IV |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Response rate | Using a Simon's two-stage model. | Up to 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response | Analyzed using the Kaplan-Meier method. | Up to 6 years |
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Inclusion Criteria:
Histologically or cytologically confirmed recurrent or refractory non-Hodgkin's lymphoma (NHL) of any histologic subtype
Indolent
Aggressive
Bidimensionally measurable disease
No more than 3 prior treatment regimens as follows:
No known brain metastases
Performance status - ECOG 0-2
Performance status - Karnofsky 50-100%
WBC count at least 3,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Bilirubin normal
SGOT/SGPT no greater than 2.5 times upper limit of normal
Creatinine normal
Creatinine clearance at least 60 mL/min
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
No neuropathy greater than grade 1
No history of allergy to platinum compounds or antiemetics
No uncontrolled illness
No active infection
Not pregnant or nursing
Fertile patients must use effective contraception
No concurrent colony-stimulating factors during first course of therapy
At least 4 weeks since prior chemotherapy
At least 4 weeks since prior radiotherapy
No other concurrent investigational drugs
No concurrent antiretroviral therapy for HIV-positive patients
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| Name | Affiliation | Role |
|---|---|---|
| Anas Younes | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D007119 | Immunoblastic Lymphadenopathy |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D002051 | Burkitt Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D000072281 | Lymphadenopathy |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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