Liposomal Vincristine in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma

Study Overview
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Brief Summary
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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 liposomal vincristine in treating patients who have refractory or relapsed non-Hodgkin's lymphoma.

Detailed Description
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OBJECTIVES: Determine the complete and partial tumor responses in patients with aggressive non-Hodgkin's lymphoma that is refractory to or relapsed after second-line combination chemotherapy treated with vincristine sulfate liposomes injection. Determine the toxicity of this treatment regimen in these patients. Determine the duration of response, time to progression, and survival in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive vincristine sulfate liposomes IV over 1 hour. Treatment repeats every 2 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks until disease progression. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 1 year.

Official Title
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Pivotal Phase II Multicenter Study of Vincristine Sulfate Liposomes Injection in Diffuse Large B-Cell Non-Hodgkin's Lymphoma That is Refractory or Relapsed After Second-Line Combination Chemotherapy Revised Title Per 03/01 SR Pivotal Phase II Multicenter Study of Vincristine Sulfate Liposomes Injection in Aggressive Non-Hodgkin's Lymphoma That is Refractory to or Relapsed After Second-Line Combination Chemotherapy

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: liposomal vincristine sulfate


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed aggressive non-Hodgkin's lymphoma including: Peripheral T-cell lymphoma not otherwise specified Anaplastic large null-/T-cell lymphoma Diffuse large B-cell lymphoma including: Primary mediastinal large B-cell lymphoma with sclerosis Intravascular large B-cell lymphoma Immunoblastic B-cell lymphoma T-cell-rich B-cell lymphoma Anaplastic large B-cell lymphoma At least one bidimensionally measurable lesion with clearly defined margins at least 2 cm in the largest dimension by physical examination or CT scan No prior or active CNS lymphoma or AIDS-related lymphoma Must have received 2 or more prior chemotherapy courses from time of diagnosis of aggressive lymphoma or from time of biopsy-proven transformation from indolent to aggressive Prior first and second-line therapy must have been combination chemotherapy Prior first-line chemotherapy regimen must have contained anthracycline Must have had at least a minor response to first-line therapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 500/mm^3 (unless due to lymphoma bone marrow involvement) Platelet count at least 50,000/mm^3 (unless due to lymphoma bone marrow involvement) Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) ALT no greater than 4 times ULN Alkaline phosphatase no greater than 4 times ULN Renal: Not specified Neurologic: No prior neurological disorders unrelated to chemotherapy (including familial neurological diseases or acquired demyelinating disorders) No neuromuscular impairment (neuromotor, neurosensory, or neurocerebellar) No prior grade 3 or 4 sensory or motor neuropathy related to chemotherapy Other: No uncontrolled severe medical illness or infection HIV negative No other malignancies within the past 5 years except curatively resected basal cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: See Radiotherapy No prior allogeneic bone marrow or peripheral blood stem cell transplantation At least 4 weeks since prior immunotherapy No concurrent biological agents Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: At least 4 weeks since prior corticosteroids at a dose greater than 10 mg/day of prednisone or equivalent Radiotherapy: Prior involved-field radiotherapy allowed if irradiated area is not the only source of measurable disease Prior total body radiotherapy with high-dose therapy and autologous stem cell transplantation allowed At least 4 weeks since prior radiotherapy No concurrent radiotherapy to any disease site Surgery: At least 4 weeks since prior major surgery except for diagnosis of lymphoma No concurrent surgical removal of any indicator lesion Other: At least 4 weeks since prior alternative or investigational anticancer treatment No other concurrent systemic anticancer therapy No other concurrent investigational drug No concurrent phenytoin No concurrent hepatic drug metabolism inhibitors or inducers (cytochrome P450 isoenzymes in the CYP 3A subfamily)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: liposomal vincristine sulfate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult T-cell leukemia/lymphoma, anaplastic large cell lymphoma