Monoclonal Antibody Therapy in Treating Patients With Advanced Cancer

University of Arizona logo

University of Arizona

Status and phase

Completed
Phase 1

Conditions

Multiple Myeloma and Plasma Cell Neoplasm
Unspecified Adult Solid Tumor, Protocol Specific
Chronic Myeloproliferative Disorders
Precancerous/Nonmalignant Condition
Lymphoma
Leukemia
Myelodysplastic Syndromes

Treatments

Biological: monoclonal antibody E2.3
Biological: monoclonal antibody A27.15

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00003082
P30CA023074 (U.S. NIH Grant/Contract)
UARIZ-HSC-95178
NCI-T96-0025
CDR0000065781

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems