Trial of an Intratumoral Injections of INXN-3001 in Subjects With Stage III or IV Melanoma

NCT00815607 | Completed Phase 1

• 2 other identifiers: RTS-M101B'NIH OBA 0710-881
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 8

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.

Conditions

Melanoma

Keywords

melanoma; biologic; immunotherapy; cancer

Outcome Measures

Primary Outcomes (1)

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

  throughout the study

Secondary Outcomes (1)

• 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

Interventions

INXN-1001 DRUG

Capsules given once daily for 14 days for 3 treatment cycles.

INXN-3001 BIOLOGICAL

Intratumoral injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Less than 30 days (before the first dose of study medication) have elapsed since the completion of prior chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any first line therapy;
• Clinically significant cerebrovascular disease;
• History of or concurrent severe cardiac insufficiency (New York Heart Association Class III or IV) or coronary artery disease;
• QTc interval of \>470 ms on screening;
• Inability to measure the QT interval due to conduction abnormalities such as Bundle Branch Block (left or right) or persistent cardiac arrhythmia e.g. atrial fibrillation, or cardiac pacemaker;

Sponsors & Collaborators

• Alaunos Therapeutics: lead

Study Sites (8)

The Angeles Clinic and Research Institute

Santa Monica, California, 90404, United States

Location

Helen F. Graham Cancer Center

Newark, Delaware, 19713, United States

Location

• Nancy N. and J.C. Lewis Cancer Center & Research Pavilion at St. Joseph/Candles

Savannah, Georgia, 31405, United States

Location

Oncology Specialists, S.C.

Park Ridge, Illinois, 60068, United States

Location

Goshen Clinic

Goshen, Indiana, 46526, United States

Location

Billings Clinic

Billings, Montana, 59101, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Mary Crowley Cancer Research Centers

Dallas, Texas, 75201, United States

Location

MeSH Terms

Conditions

Melanoma; Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Andrew Marsh

  Ziopharm Oncology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2008
• First Posted: December 30, 2008
• Study Start: April 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: July 18, 2013

Record last verified: 2013-07

Locations

US (8)