Monoclonal Antibody Therapy in Treating Patients With Advanced Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Arizona
ClinicalTrials.gov Identifier:
NCT00003082
First received: November 1, 1999
Last updated: March 12, 2010
Last verified: May 2007
  Purpose

RATIONALE: Monoclonal 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 monoclonal antibodies in treating patients who have advanced cancer.


Condition Intervention Phase
Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Precancerous/Nonmalignant Condition
Unspecified Adult Solid Tumor, Protocol Specific
Biological: monoclonal antibody A27.15
Biological: monoclonal antibody E2.3
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase IA Trial of Combined Murine IgG Monoclonal Anti-Transferrin Receptor Antibodies E2.3 and A27.15 in Cancer Patients

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Lymphoma, Small Cleaved-cell, Diffuse Leukemia, Myeloid Chronic Myeloid Leukemia Myelodysplastic Syndromes Multiple Myeloma Chronic Myeloproliferative Disorders Acute Lymphoblastic Leukemia Hodgkin Lymphoma Waldenstrom Macroglobulinemia Acute Myelocytic Leukemia Acute Non Lymphoblastic Leukemia Acute Myeloid Leukemia, Adult Follicular Lymphoma B-cell Lymphomas Myelofibrosis Burkitt Lymphoma Lymphoma, Large-cell Lymphoma, Large-cell, Immunoblastic Plasmablastic Lymphoma Lymphoblastic Lymphoma Anaplastic Large Cell Lymphoma Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Chronic Myelomonocytic Leukemia Monoclonal Gammopathy of Undetermined Significance Central Nervous System Lymphoma, Primary Mantle Cell Lymphoma AL Amyloidosis Polycythemia Vera Essential Thrombocythemia Leukemia, T-cell, Chronic Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Hairy Cell Leukemia Anaplastic Plasmacytoma Large Granular Lymphocyte Leukemia
U.S. FDA Resources

Further study details as provided by University of Arizona:

Estimated Enrollment: 27
Study Start Date: December 1997
Study Completion Date: February 2001
Primary Completion Date: February 2001 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the toxicities associated with a 4-hour infusion of antitransferrin receptor antibodies with one antibody administered by itself for 1 hour before the second antibody infusion is started. II. Determine the pharmacokinetics of monoclonal antibodies E2.3 and A27.15.

OUTLINE: This is a dose escalating study. Patients receive antitransferrin antibody A27.15 IV over 4 hours. One hour after the initiation of the A27.15 infusion, infusion of antibody E2-3 is added by IV piggy back. In the absence of antimouse antibodies and toxic effects, treatment continues once every 4 weeks in patients achieving minimal, partial, or complete remission. Treatment ceases in patients experiencing stable or progressive disease. In the absence of dose limiting toxicity in the first 3 patients treated, subsequent cohorts of 6 patients each receive escalating doses of antitransferrin antibodies E2.3 and A27.15 on the same dose schedule. If dose limiting toxicity occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the MTD. Patients are followed for 3 weeks.

PROJECTED ACCRUAL: This study will accrue 18-27 patients within 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Refractory or recurrent advanced malignancy following known standard effective therapy or advanced malignancy for which no standard effective therapy exists Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: At least 2 months Hematopoietic: Absolute neutrophil count at least 1800/mm3 Hematocrit at least 30 mg/dL Platelet count at least 50,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal unless due to disease, then less than 3.5 times normal Transaminases less than 3 times upper limit of normal (ULN) (less than 5 times ULN if due to liver metastases) Renal: Creatinine no greater than 2.5 times normal Cardiovascular: No severe cardiac abnormalities Must have adequate venous access No history of sustained ventricular arrhythmia or unexplained syncope Pulmonary: No severe pulmonary abnormalities Other: Not pregnant or nursing Effective contraception required of fertile female patients No serious concurrent medical or psychiatric illness Adequate nutrition No human antimouse antibodies

PRIOR CONCURRENT THERAPY: At least 4 weeks since prior anticancer therapy and recovered If there was disease progression during therapy, at least 2 weeks since prior anticancer therapy and recovered Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy Endocrine therapy: Concurrent topical steroids used in the chronic management of cutaneous T cell lymphoma allowed No other concurrent hormone therapy Radiotherapy: No concurrent palliative radiotherapy Surgery: Not specified

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003082

Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Investigators
Study Chair: Michael Lobell, MD University of Arizona
  More Information

Additional Information:
No publications provided

Responsible Party: Michael Lobell, M.D., Arizona Cancer Center at University of Arizona Health Science Center
ClinicalTrials.gov Identifier: NCT00003082     History of Changes
Other Study ID Numbers: CDR0000065781, P30CA023074, UARIZ-HSC-95178, NCI-T96-0025
Study First Received: November 1, 1999
Last Updated: March 12, 2010
Health Authority: United States: Federal Government

Keywords provided by University of Arizona:
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
monoclonal gammopathy of undetermined significance
recurrent adult Hodgkin lymphoma
isolated plasmacytoma of bone
extramedullary plasmacytoma
refractory multiple myeloma
Waldenstrom macroglobulinemia
stage III multiple myeloma
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
unspecified adult solid tumor, protocol specific
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
untreated adult acute lymphoblastic leukemia
untreated adult acute myeloid leukemia
adult acute myeloid leukemia in remission
adult acute lymphoblastic leukemia in remission
polycythemia vera
chronic idiopathic myelofibrosis
essential thrombocythemia
untreated hairy cell leukemia
progressive hairy cell leukemia, initial treatment
refractory hairy cell leukemia

Additional relevant MeSH terms:
Neoplasms
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Precancerous Conditions
Lymphoma, Large-Cell, Immunoblastic
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2014