Angioimmunoblastic T-cell LymphomaPhase 2NCT00006473
Oxaliplatin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase 2 study testing oxaliplatin in people with Angioimmunoblastic T-cell Lymphoma and Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase II trial to study the effectiveness of oxaliplatin in treating patients who have relapsed or refractory non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angioimmunoblastic T-cell Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma
- What is being tested?
- oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to Feb 2006
- 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
Who may be able to join
- Histologically or cytologically confirmed recurrent or refractory non-Hodgkin's lymphoma (NHL) of any histologic subtype
- Indolent
- Follicular small cleaved cell
- Follicular mixed cell
- Small lymphocytic
- Mucosa-associated lymphoid tissue (MALT)
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- Monocytoid B-cell
- Waldenstrom's macroglobulinemia
- Aggressive
- Follicular large cell
- Diffuse large cell
- Immunoblastic
- Mantle cell
- Ki-1+ NHL
- Peripheral T-cell
- Angiocentric and angioimmunoblastic
- Transformed lymphoma
- Bidimensionally measurable disease
- No more than 3 prior treatment regimens as follows:
- Primary radiotherapy is 1 regimen
- Combined therapy with radiotherapy and chemotherapy is 1 regimen
- Alternating therapy is 1 regimen
- No known brain metastases
- Performance status - ECOG 0-2
- Performance status - Karnofsky 50-100%
- WBC count at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin normal
- SGOT/SGPT no greater than 2.5 times upper limit of normal
- Creatinine normal
- Creatinine clearance at least 60 mL/min
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No neuropathy greater than grade 1
- No history of allergy to platinum compounds or antiemetics
- No uncontrolled illness
- No active infection
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No concurrent colony-stimulating factors during first course of therapy
- At least 4 weeks since prior chemotherapy
- At least 4 weeks since prior radiotherapy
- No other concurrent investigational drugs
- No concurrent antiretroviral therapy for HIV-positive patients
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Oxaliplatin in Relapsed and Refractory Non-Hodgkin's Lymphoma
Phase II trial to study the effectiveness of oxaliplatin in treating patients who have relapsed or refractory non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Read the detailed description
OBJECTIVES:
- Determine the response rate to oxaliplatin in patients with relapsed or refractory non-Hodgkin's lymphoma.
II. Determine the treatment-related toxicity of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to histologic subtype (indolent vs aggressive).
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A maximum of 72 patients will be accrued for this study within 2-3 years.
- Conditions
- Angioimmunoblastic T-cell Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma
- Being tested
- oxaliplatin
- Medical subject headings
- Immunoblastic Lymphadenopathy, Lymphoma, B-Cell, Marginal Zone, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Immunoblastic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatinDrug
Also called 1-OHP, Dacotin, Dacplat, Eloxatin
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (oxaliplatin) | Experimental | Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Using a Simon's two-stage model.
Measured: Up to 6 years
Secondary outcomes (1)
Duration of response
Analyzed using the Kaplan-Meier method.
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 2000
- Primary completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angioimmunoblastic T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Anas Younes, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006473
- Sponsor's protocol ID
- NCI-2012-02363
- Other IDs
- ID99-406, CDR0000068297
- Status last verified
- Jan 2013
- First submitted
- 6 Nov 2000
- Last updated
- 23 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Oxaliplatin in Relapsed and Refractory Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00006473
- Acronym / sponsor ID
- NCI-2012-02363
- Conditions
- Angioimmunoblastic T-cell Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Sep 2000
- Primary completion
- Feb 2006 (actual)
- First posted
- 27 Jan 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.
Phase II trial to study the effectiveness of oxaliplatin in treating patients who have relapsed or refractory non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed description
OBJECTIVES:
- Determine the response rate to oxaliplatin in patients with relapsed or refractory non-Hodgkin's lymphoma.
II. Determine the treatment-related toxicity of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to histologic subtype (indolent vs aggressive).
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A maximum of 72 patients will be accrued for this study within 2-3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (oxaliplatin) | Experimental | Drug: oxaliplatinPatients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (46 listed)
- Histologically or cytologically confirmed recurrent or refractory non-Hodgkin's lymphoma (NHL) of any histologic subtype
- Bidimensionally measurable disease
- No more than 3 prior treatment regimens as follows:
- No known brain metastases
- Performance status - ECOG 0-2
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| oxaliplatinAlso: 1-OHP, Dacotin, Dacplat, EloxatinGiven IV | Drug | Treatment (oxaliplatin) |
Primary outcome
Response rate
Time frame: Up to 6 years
Using a Simon's two-stage model.
1 secondary outcome
Duration of response
Time frame: Up to 6 years
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 23 Jan 2013.
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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.
Anas Younes principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oxaliplatin in people with Angioimmunoblastic T-cell Lymphoma and Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 46 inclusion and 0 exclusion criteria. 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 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does the primary outcome measure?
Response rate (time frame: Up to 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2013.