LymphomaPhase 1/2NCT00007839
Beta Alethine in Treating Patients With Low-Grade Lymphoma
A Phase 1/2 study testing beta alethine in people with Lymphoma, run by LifeTime Pharmaceuticals at 1 site in United States.
Trial summary
RATIONALE: Biological therapies such as beta alethine use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase I/II trial to study the effectiveness of beta alethine in treating patients who have low-grade 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?
- beta alethine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Aug 2000to not given
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed low grade B-cell lymphoma
- Measurable residual disease after maximal response to prior chemotherapy OR
- Indolent disease not yet requiring therapy
- No congenital immunodeficiency associated lymphoma
- No primary lymphoma of the brain
- No active brain involvement or leptomeningeal disease NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 50-100%
Life expectancy:
- At least 4 months
Hematopoietic:
- Neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 10 g/dL
Hepatic:
- Bilirubin less than 2.0 mg/dL
- SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present)
Renal:
- Creatinine no greater than 2.0 mg/dL
- Calculated creatinine clearance at least 60 mL/min
Cardiovascular:
- No uncontrolled angina, heart failure, or arrhythmia
- No acute changes on EKG
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- No AIDS
- Adequate nutritional status (total protein at least 60.0 g/L)
- No active bacterial infections (e.g., abscess or with fistula)
- No nonmalignant disease that would preclude study
- No history of alcoholism, drug addiction, or psychotic disorders that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Prior bone marrow transplantation allowed
- At least 4 weeks since prior immunotherapy or cytokines
Chemotherapy:
- See Disease Characteristics
- Prior intensive chemotherapy with stem cell support allowed
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or high dose carboplatin)
Endocrine therapy:
- No concurrent corticosteroids
Radiotherapy:
- At least 4 weeks since prior radiotherapy to more than 25% of bone marrow
Surgery:
- Recovered from prior surgery
- No prior solid organ transplantation
Other:
- No concurrent antiinflammatory agents including aspirin, or over the counter or prescription nonsteroidal antiinflammatory drugs
- No concurrent immunosuppressive agents
- No other concurrent investigational agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With B-Cell Lymphoma
RATIONALE: Biological therapies such as beta alethine use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: Phase I/II trial to study the effectiveness of beta alethine in treating patients who have low-grade lymphoma.
Read the detailed description
OBJECTIVES:
- Determine the antitumor effects of low-dose beta-alethine in patients with low grade B-cell lymphoma.
- Assess the effects of this regimen on delayed-type hypersensitivity in these patients.
- Assess the safety of this regimen in this patient population.
OUTLINE: This is an multicenter study.
Patients receive low-dose beta-alethine subcutaneously once every 2 weeks for a total of 6 doses in the absence of unacceptable toxicity. Patients with no evidence of tumor progression may receive additional courses of therapy.
Patients are followed for 2 weeks from the last dose or for a minimum of 30 days if they withdraw due to an adverse event.
PROJECTED ACCRUAL: Approximately 13-37 patients will be accrued for this study.
- Conditions
- Lymphoma
- Being tested
- beta alethine
- Keywords
- stage I grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma, stage I adult diffuse small cleaved cell lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV adult diffuse small cleaved cell lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II adult diffuse small cleaved cell lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II adult diffuse small cleaved cell lymphoma, noncontiguous stage II small lymphocytic lymphoma, noncontiguous stage II marginal zone lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Marginal Zone, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beta alethineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2003 (estimated)
- Study startAug 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- LifeTime Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Suzin Mayerson, PhD, Study chair, LifeTime Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00007839
- Sponsor's protocol ID
- CDR0000068279
- Other IDs
- LIFETIME-LTP-99-02, LIFETIME-IRB-0300202, NCI-V00-1628
- Status last verified
- Apr 2010
- First submitted
- 6 Jan 2001
- Last updated
- 18 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00007839
- Acronym / sponsor ID
- CDR0000068279
- Conditions
- Lymphoma
- Keywords
- stage I grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma, stage I adult diffuse small cleaved cell lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- LifeTime PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2000
- First posted
- 8 Oct 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: Biological therapies such as beta alethine use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: Phase I/II trial to study the effectiveness of beta alethine in treating patients who have low-grade lymphoma.
Detailed description
OBJECTIVES:
- Determine the antitumor effects of low-dose beta-alethine in patients with low grade B-cell lymphoma.
- Assess the effects of this regimen on delayed-type hypersensitivity in these patients.
- Assess the safety of this regimen in this patient population.
OUTLINE: This is an multicenter study.
Patients receive low-dose beta-alethine subcutaneously once every 2 weeks for a total of 6 doses in the absence of unacceptable toxicity. Patients with no evidence of tumor progression may receive additional courses of therapy.
Patients are followed for 2 weeks from the last dose or for a minimum of 30 days if they withdraw due to an adverse event.
PROJECTED ACCRUAL: Approximately 13-37 patients will be accrued for this study.
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 |
|---|---|---|
| beta alethine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 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.
Suzin Mayerson, PhD study chair
LifeTime Pharmaceuticals
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 beta alethine in people with Lymphoma, run by LifeTime Pharmaceuticals 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?
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: status not confirmed, as of the sponsor's last update on 18 Dec 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 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?
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 18 Dec 2013.