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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.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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 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.

  1. First posted8 Oct 2003 (estimated)
  2. Study startAug 2000

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
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

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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