A Phase IA Trial of Combined Murine IgG Monoclonal Anti-Transferrin Receptor Antibodies E2.3 and A27.15 in Cancer Patients
18 Years
N/A
Both
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Precancerous/Nonmalignant Condition, Unspecified Adult Solid Tumor, Protocol Specific
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 Center | Tucson, Arizona 85724 |
