Anaplastic Large Cell LymphomaPhase 2NCT00278382
Sorafenib in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
A Phase 2 study testing sorafenib tosylate and laboratory biomarker analysis in people with Anaplastic Large Cell Lymphoma and Recurrent Adult Diffuse Large Cell Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Sorafenib may stop the growth of cancer cells by blocking blood flow to the cancer and by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well sorafenib works in treating patients with chemosensitive recurrent aggressive non-Hodgkin's lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaplastic Large Cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Mantle Cell Lymphoma
- What is being tested?
- sorafenib tosylate and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Dec 2007
- 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 aggressive* non-Hodgkin's lymphoma by excisional-node biopsy or core needle biopsy and bone marrow biopsy, including 1 of the following types:
- Mantle cell lymphoma
- Primary mediastinal large B-cell lymphoma
- Diffuse large B-cell lymphoma
- Anaplastic large cell lymphoma (T-cell or null-cell type)
- Recurrent disease
Show all 50Show fewer
- Patients must have received ≥ 1 induction regimen containing anthracyclines (e.g., CHOP [with or without rituximab] or R-EPOCH)
- Chemosensitive disease at the time of relapse
- Patients who responded with a complete or partial remission that lasted at least 8 weeks after their last chemotherapy regimen are considered chemosensitive
- Measurable disease, defined as a lymph node or a nodal mass of > 1 cm in its longest transverse diameter on CT scan
- Ineligible for, refused, or relapsed after stem cell transplant (for patients with non-mantle cell lymphoma)
- No known brain metastases, including meningeal involvement
- ECOG performance status (PS) 0-2
- Karnofsky PS 60-100%
- Life expectancy > 3 months
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- Fertile patients must use effective contraception
- Not pregnant or nursing
- Negative pregnancy test
- No uncontrolled illness
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib
- No known positive HIV serology
- No inflammatory bowel disease
- No swallowing dysfunction that would prevent ingestion of pills
- No hemorrhagic diathesis
- No ongoing or active infection
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No uncontrolled hypertension
- No psychiatric or social situation that would limit compliance with study requirements
- No poorly controlled medical condition that would seriously complicate compliance with this study
- Patients with inflammatory or exfoliative skin disease are excluded (regardless of the extent of the involvement) unless the skin condition is lymphoma related
- See Disease Characteristics
- Previous treatment-related toxic effects should be resolved to grade 1 or better
- No chemotherapy or radiation therapy within the past 4 weeks
- 6 weeks for nitrosoureas or mitomycin C
- No prior antibody therapy for at least 3 months
- Prior radiation for localized disease or total body irradiation as part of a conditioning regimen prior to stem cell transplant allowed
- Prior radio-immunotherapy allowed
- No concurrent therapeutic anticoagulation
- Prophylactic anticoagulation (i.e., low-dose warfarin) of venous or arterial access devices are acceptable provided that the requirements for PT, INR, and PTT are met
- No concurrent use of another investigational agent
- No concurrent use of the following drugs: phenytoin, carbamazepine, phenobarbital, rifampin, or Hypericum perforatum (St. John's wort)
- No other concurrent anticancer therapy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201-1595
About this study
Official title: A Phase 2 Study of BAY 43-9006 (IND 69896) in Chemosensitive Relapsed Aggressive Non-Hodgkin's Lymphomas
Sorafenib may stop the growth of cancer cells by blocking blood flow to the cancer and by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well sorafenib works in treating patients with chemosensitive recurrent aggressive non-Hodgkin's lymphoma
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the overall response rate, including complete and partial responses, in patients with chemosensitive, relapsed, aggressive, non-Hodgkin's lymphoma treated with sorafenib.
SECONDARY OBJECTIVES:
- Determine progression-free and overall survival of patients treated with this drug.
II. Determine response duration in patients treated with this drug.
OUTLINE: This is an open-label study.
Patients receive oral sorafenib twice daily in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
- Conditions
- Anaplastic Large Cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Mantle Cell Lymphoma
- Being tested
- sorafenib tosylate, laboratory biomarker analysis
- Medical subject headings
- Lymphoma, Large-Cell, Anaplastic, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sorafenib tosylateDrug
Also called BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar
Given orally
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (sorafenib tosylate) | Experimental | Patients receive oral sorafenib twice daily in the absence of disease progression or unacceptable toxicity. Receives: Drug: sorafenib tosylate; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (complete and partial response)
Will be calculated as the percent of evaluable patients whose best response is a CR or PR. The exact binomial method will be used to determine the confidence interval of response rate.
Measured: Up to 2 years
Secondary outcomes (2)
Overall survival
The Kaplan-Meier product-limit method will be used in analysis of survival time.
Measured: Up to 2 years
Time to disease progression
The Kaplan-Meier product-limit method will be used in analysis of time to disease progression.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2006 (estimated)
- Study startOct 2005
- Primary completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaplastic Large 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Meyer Heyman, Principal investigator, University of Maryland Greenebaum Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00278382
- Sponsor's protocol ID
- NCI-2012-02682
- Other IDs
- GCC0508, CDR0000456442
- Status last verified
- Feb 2013
- First submitted
- 16 Jan 2006
- Last updated
- 7 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of BAY 43-9006 (IND 69896) in Chemosensitive Relapsed Aggressive Non-Hodgkin's Lymphomas
- ClinicalTrials.gov ID
- NCT00278382
- Acronym / sponsor ID
- NCI-2012-02682
- Conditions
- Anaplastic Large Cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Mantle Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Oct 2005
- Primary completion
- Dec 2007 (actual)
- First posted
- 18 Jan 2006 (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.
Sorafenib may stop the growth of cancer cells by blocking blood flow to the cancer and by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well sorafenib works in treating patients with chemosensitive recurrent aggressive non-Hodgkin's lymphoma
Detailed description
PRIMARY OBJECTIVES:
- Determine the overall response rate, including complete and partial responses, in patients with chemosensitive, relapsed, aggressive, non-Hodgkin's lymphoma treated with sorafenib.
SECONDARY OBJECTIVES:
- Determine progression-free and overall survival of patients treated with this drug.
II. Determine response duration in patients treated with this drug.
OUTLINE: This is an open-label study.
Patients receive oral sorafenib twice daily in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (sorafenib tosylate) | Experimental | Drug: sorafenib tosylate, Other: laboratory biomarker analysisPatients receive oral sorafenib twice daily 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 (50 listed)
- Histologically or cytologically confirmed aggressive* non-Hodgkin's lymphoma by excisional-node biopsy or core needle biopsy and bone marrow biopsy, including 1 of the following types:
- Recurrent disease
- Patients must have received ≥ 1 induction regimen containing anthracyclines (e.g., CHOP [with or without rituximab] or R-EPOCH)
- Chemosensitive disease at the time of relapse
- Measurable disease, defined as a lymph node or a nodal mass of > 1 cm in its longest transverse diameter on CT scan
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 |
|---|---|---|
| sorafenib tosylateAlso: BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, NexavarGiven orally | Drug | Treatment (sorafenib tosylate) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (sorafenib tosylate) |
Primary outcome
Objective response rate (complete and partial response)
Time frame: Up to 2 years
Will be calculated as the percent of evaluable patients whose best response is a CR or PR. The exact binomial method will be used to determine the confidence interval of response rate.
2 secondary outcomes
Overall survival
Time frame: Up to 2 years
Time to disease progression
Time frame: Up to 2 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 7 Feb 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.
Meyer Heyman principal investigator
University of Maryland Greenebaum 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 sorafenib tosylate and laboratory biomarker analysis in people with Anaplastic Large Cell Lymphoma and Recurrent Adult Diffuse Large Cell Lymphoma, 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 50 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 7 Feb 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?
Objective response rate (complete and partial response) (time frame: Up to 2 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 7 Feb 2013.