Trial record 2 of 6 for:    tocagen

A Study of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC in Subjects With Solid Tumors (Toca6)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2016 by Tocagen Inc.
Sponsor:
Information provided by (Responsible Party):
Tocagen Inc.
ClinicalTrials.gov Identifier:
NCT02576665
First received: October 12, 2015
Last updated: January 20, 2016
Last verified: January 2016
  Purpose
This is a multicenter, open label, single arm study of Toca 511 and Toca FC. Based on their cancer diagnosis (brain metastases from non small cell lung cancer or breast cancer; colorectal cancer with liver metastases; metastatic renal cell carcinoma; locally advanced or recurrent melanoma) subjects will receive Toca 511 either intravenously (IV) or intralesionally (IL). At least 3 subjects will be enrolled for each disease group. In all but the melanoma group, Toca 511 will be administered by IV injection for 5 consecutive days (27 mL per day); in the melanoma group, at least 3 subjects will receive Toca 511 by IV injection (same dosing regimen as the other 3 groups), and at least 3 subjects will receive Toca 511 by IL injection (approximately 0.1 mL to 4 mL for 5 consecutive days). Based on the disease group, subjects will have either multiple core biopsies or a resection of a metastatic lesion (primary for renal cell carcinoma), approximately 14 to 28 days after Toca 511 administration. A portion of the resected or biopsied tumor sample will be evaluated for the presence of Toca 511 vector sequences and markers for disease characteristics. After recovery from the biopsy or surgery (approximately 6 weeks from Toca 511 treatment start), subjects will begin oral Toca FC (7 day courses at 220 mg/kg/day, to be repeated approximately every 6 weeks), alone or in conjunction with standard therapy (other investigational treatments prohibited). One or more disease groups may be expanded to allow replacement of subjects or to provide a better assessment of efficacy. Subjects will be followed for safety for up to 15 years as required by regulatory authorities. In addition, subjects will be followed for efficacy (objective response and survival).

Condition Intervention Phase
Metastatic Colorectal Cancer
Metastatic Renal Cell Carcinoma
Metastatic Melanoma
Brain Metastasis
Biological: Toca 511
Drug: Toca FC
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1b Study of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC in Subjects With Solid Tumors

Resource links provided by NLM:


Further study details as provided by Tocagen Inc.:

Primary Outcome Measures:
  • Number of patients with vector deposition detected in the resected tumor specimens following administration of Toca 511 [ Time Frame: Assessment of virus deposition 6 months after FPFV ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients who received Toca 511 and Toca FC with treatment related adverse events as assessed by CTCAE v4.0 [ Time Frame: Assessment of safety 6 months after FPFV ] [ Designated as safety issue: Yes ]
  • Number of surviving patients who do not have documented tumor progression following treatment [ Time Frame: Evaluate response 2 years after FPFV ] [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: February 2016
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Toca 511/Toca FC

Toca 511: For subjects allocated to intravenous administration of Toca 511, 27 mL will be administered daily for 5 consecutive days. For subjects allocated to intralesional administration of Toca 511, 0.1 mL to 4 mL will be administered to the same lesion(s) daily for 5 days.

Toca FC: After recovery from resection or biopsy (approximately 6 weeks from Toca 511), subjects will begin a 7 day course of oral Toca FC at 220 mg/kg/day, to be repeated approximately every 6 weeks.

Biological: Toca 511
Toca 511 consists of a purified retroviral replicating vector encoding a modified yeast cytosine deaminase (CD) gene. The CD gene converts the antifungal 5-flurocytosine (5FC) to the anticancer drug 5-FU in cells that have been infected by the Toca 511 vector
Other Names:
  • vocimagene amiretrorepvec
  • RRV
  • retroviral replicating viral
Drug: Toca FC
Toca FC is an extended-release formulation of flucytosine. Toca FC is supplied as 500 mg white, oblong tablets with "TOCA FC" embossed on one side and "500" embossed on the other side
Other Names:
  • Flucytosine
  • 5-FC
  • 5-Fluorocytosine

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Metastatic solid tumor, including:

    • Subjects with brain metastases with a primary tumor of non small cell lung cancer (NSCLC) or breast cancer, suitable for planned resection of brain metastasis
    • Subjects with metastatic colorectal cancer with liver metastases suitable for core biopsy
    • Subjects with renal cell carcinoma presenting with metastatic disease, with primary planned for resection
    • Subjects with locally advanced/recurrent melanoma with skin or nodal disease suitable for resection
  2. Subject has given written informed consent
  3. Subject is between 18 years old and 90 years old, inclusive
  4. Laboratory values adequate for subject to undergo surgery or biopsy, including:

    • Platelet count ≥ 100,000/mm3
    • Hgb ≥ 10 g/dL
    • Absolute neutrophil count (ANC) ≥ 1,500/mm3
    • Normal PT/PTT (subnormal PT/PTT acceptable)
    • Adequate liver function, including: total bilirubin ≤ 1.5 x ULN (unless known Gilbert's syndrome); ALT ≤ 2.5 x ULN
  5. The subject has an ECOG Performance Status ≤ 2
  6. The subject must be a candidate for biopsy or resection of at least one lesion
  7. Subject must have a life expectancy of > 3 months

Exclusion Criteria:

  1. History of other malignancy, unless the patient has been disease free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment.
  2. The subject has or had any active infection requiring antibiotic, antifungal or antiviral therapy within the past 4 weeks
  3. The subject has any bleeding diathesis, or must take anticoagulants, or antiplatelet agents, including nonsteroidal anti inflammatory drugs (NSAIDs), at the time of the scheduled resection that cannot be stopped for surgery
  4. The subject received cytotoxic chemotherapy within the past 4 weeks (6 weeks for nitrosoureas)
  5. The subject received any investigational treatment within the past 30 days or prior immunotherapy or antibody therapy within the past 45 days
  6. Severe pulmonary, cardiac or other systemic disease, specifically:

    New York Heart Association > Grade 2 congestive heart failure which is not controlled on standard therapy within 6 months prior to study entry Uncontrolled or significant cardiovascular disease, clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation, or Torsades des pointes), clinically significant pulmonary disease (such as ≥ Grade 2 dyspnea, according to CTCAE 4.03)

  7. Subjects who have any other disease, either metabolic or psychological, which as per Investigator assessment may affect the subject's compliance or place the subject at higher risk of potential treatment complications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02576665

Contacts
Contact: Asha Das, MD 858-412-8468 adas@tocagen.com
Contact: Mary Lovely 858-412-8473 mlovely@tocagen.com

Sponsors and Collaborators
Tocagen Inc.
Investigators
Principal Investigator: Joel Randolph Hecht, MD University of California, Los Angeles
Principal Investigator: Manmeet Ahluwallia, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Tocagen Inc.
ClinicalTrials.gov Identifier: NCT02576665     History of Changes
Other Study ID Numbers: Tg 511-15-02 
Study First Received: October 12, 2015
Last Updated: January 20, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on February 04, 2016