Phase 2 Study of Thermodox as Adjuvant Therapy With Thermal Ablation (RFA) in Treatment of Metastatic Colorectal Cancer(mCRC)

NCT01464593 | Terminated Phase 2 Results DMC

• 1 other identifier: 104-10-201
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to determine the safety and efficacy of Thermodox, a thermally sensitive liposomal doxorubicin, in combination with thermal ablation in the treatment of hepatic colorectal liver metastases (CRLM).

Conditions

Colon Cancer Liver Metastasis

Keywords

Colorectal Liver Metastasis; Colon Cancer; Liver Cancer; Liver Metastasis; Liver metastases

Outcome Measures

Primary Outcomes (1)

• Determine the Local Tumor Control at 1 Year Post Randomization

  Subject's treated with thermal ablation in conjunction with Thermodox to evaluate local tumor control defined as complete ablation and does not experience recurrence within 1 cm of the ablation site.

  1 year

Secondary Outcomes (3)

• Evaluation of Safety

  1 month

• Time to Local Recurrence

  2 years

• Overall Survival

  3 years

Study Arms (1)

Thermodox

EXPERIMENTAL

Thermodox 50 mg/m2 intravenous infusion over 30 minutes starting 15 minutes before thermal ablation.

Drug: Lyso-Thermosensitive Liposomal Doxorubicin; Other: 5% Dextrose Solution; Drug: ThermoDox

Interventions

Lyso-Thermosensitive Liposomal Doxorubicin DRUG

Thermally sensitive liposomal doxorubicin 50 mg/m2 single 30 minute intravenous infusion.

Also known as: Liposomal doxorubicin, Doxorubicin, Thermodox

Thermodox

5% Dextrose Solution OTHER

Single 30 minute intravenous infusion

Thermodox

ThermoDox DRUG

ThermoDox is a Lyso-thermosensitive Liposomal Doxorubicin designed to be used in conjunction with thermal ablation.

Thermodox

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologic diagnosis of colorectal cancer.
• A minimum of 1 unresectable mCRC liver lesion at baseline clinically indicated for radiofrequency ablation (RFA) or microwave ablation (MWA).
• Recurrent lesions may have been treated previously by resection or ablation.
• Anticipated ablation volume will be no larger than either removal of 3 hepatic segments or removal of more than 30% of total liver volume (as per maximum surgical limit).
• Patients may have resectable lesions that are treated surgically.
• If additional lesions are discovered during the ablation treatment procedure that were undetectable at screening will be treated at the discretion of the physician and guided by local standard of care.
• Confirm the lesions are malignant by a pretreatment biopsy or by a biopsy obtained during the ablation procedure.
• Subjects with suspected or limited extra-hepatic mCRC are eligible provided thermal ablation is clinically indicated. Chemotherapy is not permitted within 5 half-lives or 30 days if shorter prior to initial study treatment through 30 days following final study treatment.
• Male or female 18 years of age or older.
• Are willing to sign an informed consent form.
• Left Ventricular Ejection Fraction(LVEF) ≥ 50%
• Willing to return to the study site for study visits.
• Have ECOG performance status ≤ 2 and life expectancy of ≥ 6 months.

You may not qualify if:

• Concomitant bowel surgery and/or synchronous colon resection.
• Have serious illnesses including, but not limited to, congestive heart failure;life threatening cardiac arrhythmia; or myocardial infarction or cerebral vascular accident within the last 6 months.
• Have previously received any doxorubicin (study subjects being considered for completion of treatment may have received ThermoDox previously).
• Are pregnant or breast-feeding. In women of childbearing potential, a negative pregnancy test (serum) is required within 14 days prior to study treatment.
• Women and men of childbearing potential who are not practicing an acceptable form of birth control (i.e. diaphragm, cervical cap, condom, surgical sterility or birth control pills.
• Have any known allergic reactions to any of the drugs or liposomal components or intravenous imaging agents to be used in this study.
• Have portal or hepatic vein tumor invasion/thrombosis.
• Have INR \> 1.5 times the institution's upper normal limit (UNL), except in subjects who are therapeutically anticoagulated for medical conditions unrelated to CRLM such as atrial fibrillation. Subjects may be re-screened after condition is treated or anticoagulant is withheld.
• Have platelet count \< 75,000/mm3, absolute neutrophil count \< 1500/mm3, or Hgb \< 10.0 g/dL (unless the hemoglobin value has been stable, the subject is cardiovascularly stable, asymptomatic, and judged able to withstand the RFA procedure).
• Have serum creatinine ≥ 2.5 mg/dL or calculated creatinine clearance (CrCl) ≤ 25.0 mL/min.
• Have serum bilirubin \> 3.0 mg/dL.
• Have serum albumin \< 2.8 g/dL.
• Have body temperature \> 38.3°C immediately prior to study treatment.
• Have contraindications to receiving doxorubicin HCl.
• Are being treated with other investigational agents or use of an investigational agent within 5 half-lives or 30 days whichever is longer preceding the first dose of study medication.

Sponsors & Collaborators

• Imunon: lead

Study Sites (4)

UCLA

Los Angeles, California, 90095, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Cleveland Clinic Hospital

Cleveland, Ohio, 44195, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Liver Neoplasms

Interventions

liposomal doxorubicin; Doxorubicin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Celsion Corporation

nborys@celsion.com

609-896-9100

Study Officials

• Nicholas Borys, M.D.

  Imunon

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2011
• First Posted: November 3, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 13, 2022
• Results First Posted: October 13, 2022

Record last verified: 2022-09

Locations

US (4)