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

NCT ID: NCT00006383

Last Updated: 2013-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-06-30
• Study Completion Date: 2009-08-31

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.

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

Study Design

• Primary Study Purpose: TREATMENT

Interventions

liposomal vincristine sulfate

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inex Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Principal Investigators

Barbara Gallimore, PhD

Role: STUDY_CHAIR

Inex Pharmaceuticals

Locations

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

University of Texas Health Center at Tyler

Tyler, Texas, United States

Vermont Cancer Center

Burlington, Vermont, United States

Tom Baker Cancer Center - Calgary

Calgary, Alberta, Canada

Countries

United States; Canada

References

Rodriguez MA, Pytlik R, Kozak T, Chhanabhai M, Gascoyne R, Lu B, Deitcher SR, Winter JN; Marqibo Investigators. Vincristine sulfate liposomes injection (Marqibo) in heavily pretreated patients with refractory aggressive non-Hodgkin lymphoma: report of the pivotal phase 2 study. Cancer. 2009 Aug 1;115(15):3475-82. doi: 10.1002/cncr.24359.

Reference Type: RESULT

PMID: 19536896 (View on PubMed)

Other Identifiers

INEX-CA99002

Identifier Type: -

Identifier Source: secondary_id

UCLA-0002028

Identifier Type: -

Identifier Source: secondary_id

CDR0000068259

Identifier Type: -

Identifier Source: org_study_id