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.

Condition	Treatment or Intervention	Phase
recurrent adult immunoblastic large cell lymphoma recurrent adult T-cell leukemia/lymphoma recurrent adult diffuse large cell lymphoma anaplastic large cell lymphoma	Procedure: chemotherapy  Drug: vincristine sulfate liposomes	Phase II

Further Study Details: 

OBJECTIVES: I. 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. II. Determine the toxicity of this treatment regimen in these patients. III. Determine the duration of response, time to progression, and survival in patients treated with this regimen.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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)

--Patient Characteristics--

Age: 18 and over

Performance status: ECOG 0-3

Life expectancy: Not specified

Hematopoietic:

• Granulocyte count at least 500/mm3 (unless due to lymphoma bone marrow involvement)
• Platelet count at least 50,000/mm3 (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

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States
      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033-0804,  United States
Illinois
      Decatur Memorial Hospital Cancer Care Institute, Decatur,  Illinois,  62526,  United States
      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611-3013,  United States
      University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States
Ohio
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States
Texas
      University of Texas Health Center at Tyler, Tyler,  Texas,  75708,  United States
Vermont
      Vermont Cancer Center, Burlington,  Vermont,  05401-3498,  United States
Canada, Alberta
      Tom Baker Cancer Center - Calgary, Calgary,  Alberta,  T2N 4N2,  Canada

Study chairs or principal investigators

Barbara Gallimore,  Study Chair,  Inex Pharmaceuticals   

Study ID Numbers:  CDR0000068259; INEX-CA99002; UCLA-0002028
Record last reviewed:  May 2003
Last Updated:  October 13, 2004
Record first received:  October 4, 2000
ClinicalTrials.gov Identifier:  NCT00006383
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08