LymphomaPhase 2NCT00006383
Liposomal Vincristine in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma
A Phase 2 study testing liposomal vincristine sulfate in people with Lymphoma, run by Inex Pharmaceuticals at 9 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- liposomal vincristine sulfate
- How many people
- Not given
- Where
- 9 sitesin 2 countries
- Study dates
- Jun 2000to Aug 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
Vermont Cancer Center
Burlington, Vermont, 05401-3498
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
University of Illinois at Chicago
Chicago, Illinois, 60612
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
University of Texas Health Center at Tyler
Tyler, Texas, 75708
About this study
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
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.
Read the 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
- Being tested
- liposomal vincristine sulfate
- Keywords
- recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult T-cell leukemia/lymphoma, anaplastic large cell lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large-Cell, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal vincristine sulfateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2003 (estimated)
- Study startJun 2000
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Inex Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Barbara Gallimore, PhD, Study chair, Inex Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006383
- Sponsor's protocol ID
- CDR0000068259
- Other IDs
- INEX-CA99002, UCLA-0002028
- Status last verified
- Dec 2002
- First submitted
- 4 Oct 2000
- Last updated
- 6 Nov 2013
- Results posted
- No
Publications
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.
PubMed 19536896
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00006383
- Acronym / sponsor ID
- CDR0000068259
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Inex PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2000
- Study completion
- Aug 2009 (actual)
- First posted
- 30 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liposomal vincristine sulfate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
- Results publication: PubMed 19536896Rodriguez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Gallimore, PhD study chair
Inex Pharmaceuticals
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing liposomal vincristine sulfate in people with Lymphoma, run by Inex Pharmaceuticals at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006383, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2013.