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A Phase IA Trial of Combined Murine IgG Monoclonal Anti-Transferrin Receptor Antibodies E2.3 and A27.15 in Cancer Patients


Phase 1
18 Years
N/A
Not Enrolling
Both
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Precancerous/Nonmalignant Condition, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase IA Trial of Combined Murine IgG Monoclonal Anti-Transferrin Receptor Antibodies E2.3 and A27.15 in Cancer Patients


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael Lobell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arizona

Authority:

United States: Federal Government

Study ID:

CDR0000065781

NCT ID:

NCT00003082

Start Date:

December 1997

Completion Date:

February 2001

Related Keywords:

  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Precancerous/Nonmalignant Condition
  • Unspecified Adult Solid Tumor, Protocol Specific
  • 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
  • chronic myelomonocytic leukemia
  • T-cell large granular lymphocyte leukemia
  • acute undifferentiated leukemia
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt lymphoma
  • 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
  • stage III adult T-cell leukemia/lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • recurrent adult T-cell leukemia/lymphoma
  • secondary acute myeloid leukemia
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • prolymphocytic leukemia
  • AIDS-related peripheral/systemic lymphoma
  • AIDS-related primary CNS lymphoma
  • primary systemic amyloidosis
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • anaplastic large cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Precancerous Conditions
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Arizona Cancer CenterTucson, Arizona  85724