NCT00006383

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2000

Longer than P75 for phase_2 lymphoma

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2000

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

May 30, 2003

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

November 6, 2013

Status Verified

December 1, 2002

First QC Date

October 4, 2000

Last Update Submit

November 5, 2013

Conditions

Lymphoma

Keywords

recurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult T-cell leukemia/lymphomaanaplastic large cell lymphoma

Interventions

liposomal vincristine sulfateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (9)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

University of Texas Health Center at Tyler

Tyler, Texas, 75708, United States

Location

Vermont Cancer Center

Burlington, Vermont, 05401-3498, United States

Location

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 19536896RESULT

MeSH Terms

Conditions

LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, Large-Cell, Anaplastic

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLymphoma, Non-HodgkinPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLeukemiaHematologic DiseasesLymphoma, T-Cell

Study Officials

  • Barbara Gallimore, PhD

    Inex Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 4, 2000

First Posted

May 30, 2003

Study Start

June 1, 2000

Study Completion

August 1, 2009

Last Updated

November 6, 2013

Record last verified: 2002-12

Locations

US(8)CA(1)