Non-Hodgkin's LymphomaPhase 1/2NCT00183950
Study of Noscapine for Patients With Low Grade Non Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia Refractory to Chemotherapy
A Phase 1/2 study testing Noscapine in people with Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia, run by University of Southern California at 1 site in United States.
Trial summary
This study is for patients with non-hodgkin's lymphoma or chronic lymphocytic leukemia, which has failed to shrink or has returned after previous treatment with chemotherapy. The purpose of this study is to find out whether patients with these types of cancer will have their tumor shrunk after treatment with a drug… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia
- What is being tested?
- Noscapine
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2000to Dec 2006
- Phase
- Phase 1/2
- 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
- Patients with low grade NHL (follicular lymphoma, small cell lymphocytic lymphoma, marginal cell lymphoma, monocytoid B-cell lymphoma, MALT lymphoma, plasmacytoid lymphocytic lymphoma) or chronic lymphocytic leukemia who have demonstrated chemotherapy resistance (have not achieved CR,CRu, PR)or who have relapsed at any time following a response (CR, CRu, PR) after at least one therapy regimen, including chemotherapy, Rituximab, or high dose chemotherapy with stem cell rescue.
- Karnofsky performance status 60 % or greater.
- Creatinine less or equal to 2.0 mg/dl, bilirubin less or equal to 2.0 mg/dl, SGPT/SGOT less or equal to 4 x upper normal range
Who cannot join
- Patients with unconfirmed complete response(CRu)after last treatment and who currently remain in CRu.
- Pregnant or lactating women.
- Disease-specific treatment less than 1 month prior to starting this study.
- CNS disease.
- HIV-positive patients.
- Other cancer, except basal cell or squamous cell cancer of the skin or carcinoma in-situ of cervix.
Trial locations and contacts
1 site in 1 country.
United States1 site
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033
About this study
Official title: Phase I/II Study of Noscapine for Patients With Low Grade Non Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia Refractory to Chemotherapy
This study is for patients with non-hodgkin's lymphoma or chronic lymphocytic leukemia, which has failed to shrink or has returned after previous treatment with chemotherapy. The purpose of this study is to find out whether patients with these types of cancer will have their tumor shrunk after treatment with a drug called Noscapine. The second purpose is to see what are the side effects of this drug. This drug is being used as an over-the-counter cough suppressor in Europe and Japan, but has also shown to be effective against cancer.
- Being tested
- Noscapine
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NoscapineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMar 2000
- Primary completionDec 2006
- Study completionDec 2006
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183950
- Sponsor's protocol ID
- 0C-99-16
- Status last verified
- May 2014
- First submitted
- 9 Sep 2005
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Noscapine for Patients With Low Grade Non Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia Refractory to Chemotherapy
- ClinicalTrials.gov ID
- NCT00183950
- Acronym / sponsor ID
- 0C-99-16
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No funding
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Mar 2000
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 16 Sep 2005 (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.
This study is for patients with non-hodgkin's lymphoma or chronic lymphocytic leukemia, which has failed to shrink or has returned after previous treatment with chemotherapy. The purpose of this study is to find out whether patients with these types of cancer will have their tumor shrunk after treatment with a drug called Noscapine. The second purpose is to see what are the side effects of this drug. This drug is being used as an over-the-counter cough suppressor in Europe and Japan, but has also shown to be effective against cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with low grade NHL (follicular lymphoma, small cell lymphocytic lymphoma, marginal cell lymphoma, monocytoid B-cell lymphoma, MALT lymphoma, plasmacytoid lymphocytic lymphoma) or chronic lymphocytic leukemia who have demonstrated chemotherapy resistance (have not achieved CR,CRu, PR)or who have relapsed at any time following a response (CR, CRu, PR) after at least one therapy regimen, including chemotherapy, Rituximab, or high dose chemotherapy with stem cell rescue.
- Karnofsky performance status 60 % or greater.
- Creatinine less or equal to 2.0 mg/dl, bilirubin less or equal to 2.0 mg/dl, SGPT/SGOT less or equal to 4 x upper normal range
Key exclusion criteria (6 listed)
- Patients with unconfirmed complete response(CRu)after last treatment and who currently remain in CRu.
- Pregnant or lactating women.
- Disease-specific treatment less than 1 month prior to starting this study.
- CNS disease.
- HIV-positive patients.
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 |
|---|---|---|
| Noscapine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: No funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Noscapine in people with Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia, run by University of Southern California 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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 22 May 2014. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: No funding). Results are not available in the source record.
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?
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 22 May 2014.