Beta Alethine in Treating Patients With Low-Grade Lymphoma | NCT00007839 | Trialant
NCT00007839
Sponsor
LifeTime Pharmaceuticals
Status
Unknown status
Last Update Posted
Dec 18, 2013Estimated
Enrollment
Not provided
Phase
Phase 1Phase 2
Conditions
Lymphoma
Interventions
beta alethine
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00007839
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000068279
Secondary IDs
ID
Type
Description
Link
LIFETIME-LTP-99-02
LIFETIME-IRB-0300202
NCI-V00-1628
Brief Title
Beta Alethine in Treating Patients With Low-Grade Lymphoma
Official Title
Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With B-Cell Lymphoma
Acronym
Not provided
Organization
National Cancer Institute (NCI)NIH
Status Module
Record Verification Date
Apr 2010
Overall Recruitment Status or Expanded Access Status
Unknown status
Last Known Status
Active, not recruiting
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2000
Primary Completion Date
Not provided
Completion Date
Not provided
First Submitted Date
Jan 6, 2001
First Submission Date that Met QC Criteria
Oct 7, 2003
First Posted Date
Oct 8, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 17, 2013
Last Update Posted Date
Dec 18, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
LifeTime PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief 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.
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 Module
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
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
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Suzin Mayerson, PhD
LifeTime Pharmaceuticals
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Victory Over Cancer
Rockville
Maryland
20852
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D008223
Lymphoma
D008224
Lymphoma, Follicular
D008228
Lymphoma, Non-Hodgkin
D018442
Lymphoma, B-Cell, Marginal Zone
D015451
Leukemia, Lymphocytic, Chronic, B-Cell
Ancestor Terms
ID
Term
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D008232
Lymphoproliferative Disorders
D008206
Lymphatic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C090058
alethine
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
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
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
stage I marginal zone lymphoma
stage I small lymphocytic lymphoma
stage III small lymphocytic lymphoma
stage III marginal zone lymphoma
stage IV small lymphocytic lymphoma
stage IV marginal zone lymphoma
contiguous stage II marginal zone lymphoma
contiguous stage II small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue