Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

NCT00014560 | Terminated Phase 1 Results

• 4 other identifiers: CDR0000068556P30CA023108DMS-9806NCI-G01-1936
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of antibody therapy in treating patients who have refractory or relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

Conditions

Leukemia; Lymphoma

Keywords

refractory chronic lymphocytic leukemia; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; recurrent adult Burkitt lymphoma; recurrent mantle cell lymphoma; recurrent small lymphocytic lymphoma

Outcome Measures

Primary Outcomes (2)

• Clinical Toxicity

  This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).

  day 1-29

• Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT) of BsAb 4G7 x 22

  This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).

  Day 1-29

Secondary Outcomes (1)

• Serum Markers of Macrophage Activation

  Day 1 Hours 0,2,4,6,24, day 15 Hours 0,2,4,6,24

Study Arms (1)

Single arm

EXPERIMENTAL

Antibody

Biological: bispecific antibody 4G7xH22; Biological: sargramostim

Interventions

bispecific antibody 4G7xH22 BIOLOGICAL

Single arm

sargramostim BIOLOGICAL

Single arm

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of CD19+ non-Hodgkin's lymphoma or chronic lymphocytic leukemia * Primary refractory or multiply relapsed (after at least 2 prior chemotherapy regimens) disease * Ineligible for bone marrow or peripheral blood stem cell transplantation PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-2 Life expectancy: * More than 3 months Hematopoietic: * WBC greater than 3,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Absolute neutrophil count greater than 1,500/mm\^3 Hepatic: * Bilirubin less than 1.5 mg/dL * Alkaline phosphatase less than 2 times normal * SGPT less than 2 times normal Renal: * Creatinine clearance greater than 50 mL/min Other: * No human-anti-murine-antibody response to prior murine monoclonal antibodies * No immunological or inflammatory disease (e.g., lupus erythematosus) * No active serious infection * No other serious medical condition that would limit survival to less than 2 years * No other active malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix * No psychiatric or addictive disorder that would preclude study * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior immunotherapy allowed Chemotherapy: * See Disease Characteristics * No concurrent chemotherapy Endocrine therapy: * Concurrent steroids for adrenal failure or adverse reactions to study drug allowed * Concurrent hormonal therapy for non-disease related conditions (e.g., insulin for diabetes) allowed Radiotherapy: * Not specified Surgery: * Not specified

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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756-0002, United States

Location

MeSH Terms

Conditions

Leukemia; Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Immunoblastic; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Burkitt Lymphoma; Lymphoma, Mantle-Cell

Interventions

Antibodies, Bispecific; sargramostim

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).

Results Point of Contact

• Title: Dr. Pamela Ely
• Organization: Dartmouth Hitchcock

603-653-9071

Study Officials

• Pamela Ely, MD

  Norris Cotton Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2001
• First Posted: July 30, 2003
• Study Start: September 28, 2000
• Primary Completion: February 14, 2003
• Study Completion: February 14, 2003
• Last Updated: May 3, 2018
• Results First Posted: August 5, 2013

Record last verified: 2018-04

Locations

US (1)