Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Breast Neoplasms

Pancreatic Neoplasms

Stomach Neoplasms

Ovarian Neoplasms

Peritoneal Neoplasms

Breast Diseases

Skin Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Stomach Diseases

Abdominal Neoplasms

Peritoneal Diseases

Pancreatic Cancer

Ovarian Cancer

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Natriuretic Agents

Trastuzumab

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Furosemide

Immunoglobulins

Immunoglobulins, Intravenous

Immunologic Factors

Antineoplastic Agents, Immunological

In preparation for the study, patients screened and eligible will have a peritoneal catheter placed and the evening prior to the injection of the labeled antibody will receive furosemide. Herceptin will be administered IV followed by a single IP infusion of ²¹²Pb-TCMC-Trastuzumab. Serial sampling of blood, urine, and dosimetry will be performed following treatment to determine the toxicity, pharmacokinetics, immunogenicity, and antitumor effects.

The starting dose level will be 200 μCi/m² of ²¹²Pb-TCMC-Trastuzumab. Three to six patients will be treated at each dose level, and dose escalation will proceed if no more than 1 out of 6 patients in a cohort experiences dose limiting toxicity. Six patients will be treated at the maximum tolerated dose.

²¹²Pb-TCMC-Trastuzumab

trastuzumab

Ruby F Meredith, M.D., Ph.D.

Monoclonal antibodies can transport and deliver radioactive elements capable of releasing sufficient amounts of energy to destroy tumor cells. In this clinical trial, we will study alpha particle radio immunotherapy using lead-212 (²¹²Pb), an isotope with a short path length targeted to malignant cells by the trastuzumab antibody, as a potential treatment for metastatic diseases.

This Phase I trial is designed to determine the toxicity profile of ²¹²Pb-TCMC-Trastuzumab, its dose-limiting toxicities, and its anti-tumor effects in patients with HER-2 positive intraperitoneal cancers.

Safety Study of ²¹²Pb-TCMC-Trastuzumab Radio Immunotherapy

Phase I Trial of Intraperitoneal ²¹²Pb-TCMC-Trastuzumab for HER-2 Expressing Malignancy

Adverse events considered dose limiting toxicity:

* Grade 3 elevations of ALP, bilirubin, ALT, or AST lasting ≥7 days
* Grade 3 elevations of serum creatinine within 6 weeks of treatment
* Grade 2 elevations of serum creatinine lasting ≥7 days that occur after 6 weeks
* Grade 3 proteinuria
* Any other Grade 3 or 4 non-hematologic toxicity
* Grade 4 neutropenia lasting ≥7 days or febrile neutropenia of any duration
* Grade 3 thrombocytopenia that fails to recover to ≤ Grade 2 at 6 weeks
* Grade 4 thrombocytopenia lasting ≥7 days or thrombocytopenia accompanied by bleeding

Orano Med LLC

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