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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

United States1 site
  • Victory Over Cancer

    Rockville, Maryland, 20852

Other trials in United States

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.

  1. First posted27 Jan 2003 (estimated)
  2. Study startMar 2002

Resources

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
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

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.

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