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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
liposomal vincristine sulfate
Sponsored by
Inex Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult T-cell leukemia/lymphoma, anaplastic large cell lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • USC/Norris Comprehensive Cancer Center and Hospital
  • Jonsson Comprehensive Cancer Center, UCLA
  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
  • University of Illinois at Chicago
  • Decatur Memorial Hospital Cancer Care Institute
  • Cleveland Clinic Taussig Cancer Center
  • University of Texas Health Center at Tyler
  • Vermont Cancer Center
  • Tom Baker Cancer Center - Calgary

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 4, 2000
Last Updated
November 5, 2013
Sponsor
Inex Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00006383
Brief Title
Liposomal Vincristine in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2002
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Inex Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult T-cell leukemia/lymphoma, anaplastic large cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
liposomal vincristine sulfate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Gallimore, PhD
Organizational Affiliation
Inex Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Decatur Memorial Hospital Cancer Care Institute
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Texas Health Center at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
Facility Name
Vermont Cancer Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401-3498
Country
United States
Facility Name
Tom Baker Cancer Center - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19536896
Citation
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.
Results Reference
result

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

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