Beta Alethine in Treating Patients With Low-Grade Lymphoma

NCT00007839 | Unknown Phase 1

• 4 other identifiers: CDR0000068279LIFETIME-LTP-99-02LIFETIME-IRB-0300202NCI-V00-1628
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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; 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; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma

Interventions

beta alethine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• LifeTime Pharmaceuticals: lead

Study Sites (1)

Victory Over Cancer

Rockville, Maryland, 20852, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell, Marginal Zone; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

alethine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Suzin Mayerson, PhD

  LifeTime Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 6, 2001
• First Posted: October 8, 2003
• Study Start: August 1, 2000
• Last Updated: December 18, 2013

Record last verified: 2010-04

Locations

US (1)