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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00006383
Enrollment
Unknown
Registered
2003-05-30
Start date
2000-06-30
Completion date
2009-08-31
Last updated
2013-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult T-cell leukemia/lymphoma, anaplastic large cell lymphoma

Brief summary

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

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.

Interventions

Sponsors

Inex Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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)

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026