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| Sponsor: | Areva Med LLC |
|---|---|
| Information provided by (Responsible Party): | Areva Med LLC |
| ClinicalTrials.gov Identifier: | NCT01384253 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms Peritoneal Neoplasms Ovarian Neoplasms Pancreatic Neoplasms Stomach Neoplasms |
Other: ²¹²Pb-TCMC-Trastuzumab Biological: trastuzumab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Trial of Intraperitoneal ²¹²Pb-TCMC-Trastuzumab for HER-2 Expressing Malignancy |
Adverse events considered dose limiting toxicity:
| Estimated Enrollment: | 36 |
| Study Start Date: | July 2011 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Phase I: Dose escalation
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 potassium iodide (SSKI) and 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.
|
Other: ²¹²Pb-TCMC-Trastuzumab
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.
Biological: trastuzumab
4 mg/kg.
Other Name: Herceptin
|
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Poor organ function as defined by one of the following:
Any other severe underlying medical conditions that could impair the ability to participate in the study or the interpretation of its results related to the investigational product such as:
Contacts and Locations| United States, Alabama | |
| University Of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Ronda Carlisle, RN, BSN, OCN 205-975-2511 ronda.carlisle@ccc.uab.edu | |
| Principal Investigator: Ruby F. Meredith, M.D., Ph.D. | |
| Sub-Investigator: Sharon A. Spencer, M.D. | |
| Sub-Investigator: Ronald D. Alvarez, M.D. | |
| Sub-Investigator: Charles N. Landen, M.D., M.S. | |
| Sub-Investigator: Andres Forero-Torres, M.D. | |
| Sub-Investigator: John B. Fiveash, M.D. | |
| Principal Investigator: | Ruby F Meredith, M.D., Ph.D. | University of Alabama at Birmingham |
More Information
| Responsible Party: | Areva Med LLC |
| ClinicalTrials.gov Identifier: | NCT01384253 History of Changes |
| Other Study ID Numbers: | AREVAMED01 |
| Study First Received: | June 27, 2011 |
| Last Updated: | January 30, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
HER2+ HER-2 positive intraperitoneal intra-abdominal Lead 212 Radio Immunotherapy Alpha particle |
Antibodies Immunoglobulins Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions RIT |
|
Breast Neoplasms Neoplasms Stomach Neoplasms Ovarian Neoplasms Pancreatic Neoplasms Peritoneal Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Endocrine Gland Neoplasms |
Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Pancreatic Diseases Abdominal Neoplasms Peritoneal Diseases Trastuzumab Physiological Effects of Drugs Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |