LymphomaPhase 1/2NCT00041379
Beta Alethine in Treating Patients With Waldenstrom's Macroglobulinemia
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 Waldenstrom's macroglobulinemia. 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
- Mar 2002to 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:
- Confirmed diagnosis of Waldenstrom's macroglobulinemia
- Urine or serum protein electrophoresis showing a measurable monoclonal spike
- Indolent disease not yet requiring therapy allowed
- Positive delayed-type hypersensitivity (DTH) response
- Induration greater than 2 mm for at least 1 antigen
- No clinical signs or evidence of active brain involvement or leptomeningeal disease
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:
- Albumin at least 3.5 g/dL
- Bilirubin less than 2.0 mg/dL
- Transaminases no greater than 2.5 times upper limit of normal
Renal:
- Creatinine no greater than 2.0 mg/dL
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No acute changes on EKG
- No uncontrolled angina
- No heart failure
- No arrhythmia
Other:
- Adequate nutritional intake as evidenced by total protein at least 60 g/L
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No concurrent gastrointestinal bleed
- No active bacterial infections such as abscess or with fistulae
- HIV negative
- No other concurrent non-malignant disease that would preclude study
- No history of alcoholism, drug addiction, or psychotic disorders that would preclude follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- More than 4 weeks since prior immunotherapy
- More than 4 weeks since prior cytokines
- More than 4 weeks since prior plasmapheresis or plasma exchange
- No prior stem cell or bone marrow transplant
Chemotherapy:
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or high-dose carboplatin)
- No prior intensive chemotherapy with stem cell support
Endocrine therapy:
- More than 4 weeks since prior corticosteroids
- No concurrent corticosteroids
Radiotherapy:
- More than 4 weeks since prior radiotherapy involving more than 25% of bone marrow
Surgery:
- Recovered from any prior surgery
- No prior organ transplant
Other:
- No other concurrent investigational agent
- No concurrent immunosuppressants
- No concurrent anti-inflammatory agents including aspirin and non-steroidal anti-inflammatory 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 Waldenstrom's Macroglobulinemia
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 Waldenstrom's macroglobulinemia.
Read the detailed description
OBJECTIVES:
- Determine the antitumor effects of low-dose beta alethine in patients with Waldenstrom's macroglobulinemia.
- Determine the effects of this drug on anemia, performance status, and disease symptoms in these patients.
- Determine the effects of this drug on the immune system of these patients.
- Determine the safety of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive beta alethine subcutaneously on days 1, 15, 29, 43, 57, and 71. Courses repeat every 85 days in the absence of disease progression or unacceptable toxicity.
Patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 13-37 patients will be accrued for this study.
- Conditions
- Lymphoma
- Being tested
- beta alethine
- Keywords
- Waldenström macroglobulinemia
- Medical subject headings
- Lymphoma, Waldenstrom Macroglobulinemia
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 posted27 Jan 2003 (estimated)
- Study startMar 2002
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
- NCT00041379
- Sponsor's protocol ID
- CDR0000069494
- Other IDs
- LIFETIME-LTP-01-03
- Status last verified
- Dec 2005
- First submitted
- 8 Jul 2002
- 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 Waldenstrom's Macroglobulinemia
- ClinicalTrials.gov ID
- NCT00041379
- Acronym / sponsor ID
- CDR0000069494
- Conditions
- Lymphoma
- Keywords
- Waldenström macroglobulinemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- LifeTime PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- 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.
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 Waldenstrom's macroglobulinemia.
Detailed description
OBJECTIVES:
- Determine the antitumor effects of low-dose beta alethine in patients with Waldenstrom's macroglobulinemia.
- Determine the effects of this drug on anemia, performance status, and disease symptoms in these patients.
- Determine the effects of this drug on the immune system of these patients.
- Determine the safety of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive beta alethine subcutaneously on days 1, 15, 29, 43, 57, and 71. Courses repeat every 85 days in the absence of disease progression or unacceptable toxicity.
Patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 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.