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

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inex Pharmaceuticals
• Treatments: Vincristine

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)