Phase 1b' Open Label, Single Arm, Multicenter Trial to Evaluate the Safety, Tolerance, Response Rate and Immunological Effects of Repeated Intratumoral Injections of Adenoviral Transduced Autologous Dendritic Cells Engineered to Express hIL-12(INXN-3001) in Response to an Oral Activator Ligand in Patients With Unresectable Stage III C or IV Malignant Melanoma

Alaunos Therapeutics8 sites in 1 country12 target enrollmentApril 2009

ConditionsMelanoma

DrugsINXN-1001

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Melanoma
Sponsor: Alaunos Therapeutics
Enrollment: 12
Locations: 8
Primary Endpoint: Physical examinations, vital signs, serum chemistry, urinalysis, hematology, adverse events, and objective response rate, as assessed by diagnostic CT scans
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to test the safety of an investigational combination drug/immunotherapy for the treatment of Stage III/IV melanoma.

Detailed Description

This study will examine the effects of an oral Activator Ligand administration to modulate the timing of gene expression of human IL-12 by adenovirus-transduced dendritic cells injected into tumors.

Registry

clinicaltrials.gov

Start Date

April 2009

End Date

January 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Alaunos Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males or females of all races ≥ 18 years of age and ≤ 75 years of age;
•Unresectable Stage III C (in transit) or Stage IV melanoma (M1a, M1b, M1c with LDH ≤ 2x ULN), arising from primary cutaneous, mucosal, or subungual melanoma of any tumor thickness or from an unknown primary site;
•A minimum of 2-3 accessible nonvisceral lesions (longest diameter ≤3 cm) or palpable tumor-involved lymph nodes (longest diameter ≤5 cm) for intratumoral injections (INXN-3001) and biopsies;
•ECOG performance status of 0 or 1;
•Patients without visible brain metastases as assessed by contrast-enhanced MRI scan within 6 weeks prior to receiving study treatment;
•Adequate baseline hematological and organ function, assessed by laboratory values within 42 days (6 weeks) prior to study entry and prior to repeat treatment cycles with INXN-1001 as follows: hemoglobin ≥ 10 g/L, granulocytes \> 2500/mm3, lymphocytes \> 1000/ mm3, platelets \> 100,000/ mm3, serum creatinine \< 1.5 x ULN, AST, ALT, alkaline phosphatase \< 2.5 x ULN, LDH ≤ 2 x ULN, serum bilirubin \< 1.5 x ULN, absolute neutrophils \> 500/ mm3;
•An expected survival of at least approximately 6 months in the opinion of the investigator (as assessed mainly by performance status);
•Females must be post-menopausal or surgically sterile or practice effective contraception; Men who are not surgically sterile and whose partners are not post-menopausal or surgically sterile must practice effective contraception;
•Normal coagulation parameters as measured by PT/PTT;
•Signed, IRB-approved voluntary written informed consent.

Exclusion Criteria

•Active, acute viral, bacterial, or fungal infections requiring specific therapy;
•HIV-infection due to concerns about ability to mount an effective immune response;
•Active autoimmune disease requiring steroids (\>10 mg prednisolone or comparable) or other immunosuppressive therapy;
•Patients with detectable brain metastases at the time of screening (or within 6 weeks prior to receiving study treatment), as assessed by contrast-enhanced MRI scans;
•Patients with one or more lesion(s) \> 3cm (LD) or palpable, tumor-involved lymph node(s) \>5 cm (LD);
•Patients with a hemoglobin of \< 10 g/L;
•Presence of Stage IV visceral metastases or other distant metastases if LDH \>2 x ULN;
•Patients who have previously been treated with INXN-3001 and INXN-1001;
•Recipients of organ allografts;
•Other concurrent, clinically active malignant disease, with the exception of other cancers of the skin;

Outcomes

Primary Outcomes

Physical examinations, vital signs, serum chemistry, urinalysis, hematology, adverse events, and objective response rate, as assessed by diagnostic CT scans

Time Frame: throughout the study

Secondary Outcomes

PK of oral Activator Ligand, Immunologic responses, particularly frequency of CTLs and Tregs and hIL-12 and other cytokine levels in injected target tumor(s) and in peripheral blood, Efficacy.(throughout the study)