Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Recurrence

Breast Neoplasms

Breast Diseases

Skin Diseases

Disease Attributes

Antineoplastic Agents

All Drugs and Chemicals

Ifosfamide

Isophosphamide mustard

Mechlorethamine

Antineoplastic Agents, Alkylating

Alkylating Agents

Experimental study drug monotherapy arm (A)

Oral activator ligand with adenoviral vector injection of cancer lesions

Ad-RTS-hIL-12 and Veledimex

Small molecule chemotherapy, IV administration

Palifosfamide

Francois Lebel, MD

Phase II, randomized, safety and efficacy study in recurrent/metastatic breast cancer with accessible lesions.

Primary End point is rate of Progression Free Survival (PFS) at the 16 week treatment time point. Hypothesis: Adenoviral vector (Ad-RTS-hIL-12) alone and in combination with chemotherapy (palifosfamide) is safe and efficacious.

Multicenter, open-label, randomized study evaluating the safety and efficacy of INXN-1001 (veledimex) and INXN-2001 (Ad-RTS-hIL-12) alone and in combination with palifosfamide.

Part 1 is the safety run-in where a safety assessment will be made after 1 cycle of therapy.

Part 2, eligible subjects will be randomly assigned to active treatment Arms A or C.

Once the monotherapy (Arm A) is determined to be safe and tolerable, Part 1 combination therapy (Arm C) will begin.

Subjects should receive six cycles of study treatment, in the absence of meeting withdrawal criteria.

Adenoviral Vector Monotherapy or Combination With Chemotherapy in Subjects With Recurrent/Metastatic Breast Cancer.

A Phase II Randomized, Open Label Study of Ad-RTS-hIL-12 Monotherapy or Combination With Palifosfamide in Subjects With Recurrent/Metastatic Breast Cancer and Accessible Lesions

Proportion of subjects achieving a confirmed PR or CR according to modified RECIST v1.1

Alaunos Therapeutics

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Neuroendocrine Tumor

Neuroepithelioma

Antirheumatic Agents

Pharmaceutical Solutions

Cyclophosphamide

Treatments once a week with 2.5x10e11 VP AdCD40L, maximum 4 treatments (total dose 1x10e12 VP). If no effect in less than 2 out of 6 melanoma patients, the following 9 melanoma patients and 6 patients with other solid tumors will receive preconditioning therapy 1-2 days prior to first and last treatment with 300mg/m2 cyclophosphamid. The next 9 melanoma patients will receive one local radiotherapy.

Adenoviral serotype 5 vector, E1/E3 deleted. Human CD40L gene insert driven by RSV promoter. Vector diluted in infusion solution, 500uL solution containing 2.5x10e11 VP is intratumorally injected/treatment.

AdCD40L

Thomas H Tötterman, MD, PhD

Gustav Ullenhag, MD, PhD

Angelica SI Loskog, PhD

In this phase I/II trial, immunostimulatory gene therapy (AdCD40L) will be investigated. In Part 1 patients with melanoma will receive AdCD40L as mono therapy. In Part 2A, patients with melanoma and patients with other solid tumors will receive AdCD40L in combination with low dose cyclophosphamide. In Part 2B, patients with melanoma will receive AdCD40L in combination with one local radiotherapy and cyclophosphamide.

In this phase I/II trial, immunostimulatory gene therapy (AdCD40L) will be investigated. In Part 1 patients with melanoma (n=6) will receive AdCD40L as mono therapy. In Part 2A, patients with melanoma (n=9) and patients with other solid tumors (n=6) will receive AdCD40L in combination with low dose cyclophosphamide. In Part 2B, patients with melanoma will receive AdCD40L in combination with one local radiotherapy and cyclophosphamide. AdCD40L is given by weekly injections of 2.5x10e11 VP, 4x; total dose 1x10e12 VP. A maximum of 30 patients will be included in this trial.

AdCD40L is an adenoviral nonreplicating vector carrying the human CD40L gene. AdCD40L infects tumor cells upon intratumoral injection and deliver the CD40L gene into the cells whereupon the virus is destroyed. CD40L is then expressed as a membrane-bound protein and interacts with the CD40 receptor expressed by for example dendritic cells (DCs) in the tumor area. DCs mature upon CD40/CD40L interactions and activates tumor-specific T cell responses.

Phase I/IIa AdCD40L Immunogene Therapy for Malignant Melanoma and Other Solid Tumors

Phase I/IIa AdCD40L Immunogene Therapy for Patients With Advanced Malignant Disease.

Adverse events will be documented such as inflammation, fever, pain, changes in blood pressure, pulse etc.

Immune reactions to adenovirus will be measured by evaluating the increase of anti-adenoviral antibodies in the patients at different time points using an ELISA. Spreading of vector will be evaluated by real time PCR to detect adenovirus vector copies in blood (plasma and erythrocyte fraction).

Uppsala University Hospital

Uppsala University

Blood and Lymph Conditions

Lymphedema

Neoplasm Metastasis

Neoplastic Processes

Lymphatic Diseases

Lymfactin® will be administered as a single dose via perinodal injection in a volume of 2 mL.

Placebo will be administered as a single dose via perinodal injection in a volume of 2 mL.

Lymfactin® (1x10E11 vp)

Placebo

Anne Saarikko, MD, PhD

Maria Mani, MD, PhD

This study evaluates the efficacy of Lymfactin® in patients with secondary lymphedema associated with the treatment of breast cancer by comparing the effects of active study treatment Lymfactin® to placebo. The study product will be administered in combination with a surgical lymph node transfer operation. In addition, the safety and tolerability of the Lymfactin® treatment will be evaluated.

This is a Phase II, double-blind, placebo-controlled, multi-centre clinical study, in which 40 patients with breast cancer associated secondary lymphedema will be randomized 1:1 either to Lymfactin® (1 x 10E11 viral particles, vp) or placebo (0.9% physiological saline) group.

The study product (Lymfactin® or placebo solution) will be administered as a single dose in a volume of two (2) mL, by ex vivo perinodal injection into the fat pad of a flap of tissue containing lymph nodes from the patient's own abdominal wall or the groin area. This flap of tissue will then be surgically implanted into the axillary region of the affected arm. This treatment with the study product is performed in combination with a surgical lymph node transfer, in conjunction with or without breast reconstruction surgery.

Patients will be followed-up for efficacy and safety according to a specified schedule up to 5 years post-treatment.

Double-blind, placebo-controlled, randomized

Clinical Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema (AdeLE)

Phase 2, Double-Blind, Placebo-Controlled, Randomized Efficacy, Safety and Tolerability Study of Lymfactin in Combination With Surgical Lymph Node Transfer To Patients With Secondary Lymphedema Associated With the Treatment of Breast Cancer

Changes in anatomy and functionality of lymphatic vessels by newly developed MRI lymphangiography and comparison of the correlation of the method to the already established lymphoscintigraphy in the assessment of lymphedema.

Changes in PWC measurement of water content and edema in affected arm and comparison to the unaffected arm.

Changes in the volume of the affected arm and comparison to the unaffected arm.

Assessment of the changes in the lymphatic flow.

Assessment of changes in the quality of life using Lymphedema Quality of Life Inventory (LQOLI) in which the patients assess how their lymphedema is affecting the activities of daily living. LQOLI consists of three dimensions: Physical, psychosocial and practical, which are reported separately as the mean score of that part. Each part of the LQOLI is scored from 0 to 3, where score 0 means "no impact", 1 means "a little bit impact", 2 means "somewhat impact" and score 3 means "significant impact" on the quality of life of the patient, the smaller score thus being the better.

Adverse Events as assessed by CTCAE v4.0 to evaluate the safety profile after administration of Lymfactin.

Changes in CT scans of chest and abdomen in order to detect malignancies.

Changes in Lymfactin genome copy number in blood.

Changes in Lymfactin genome copy number in wound secretion.

Changes in anti-Lymfactin antibody titer in blood.

Changes in the VEGF-C concentration in blood.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adenoviral Vector Monotherapy or Combination With Chemotherapy in Subjects With Recurrent/Metastatic Breast Cancer.	NCT01703754	Breast Cancer N...	Ad-RTS-hIL-12 a... Palifosfamide	18 Years -	Alaunos Therapeutics
Phase I/IIa AdCD40L Immunogene Therapy for Malignant Melanoma and Other Solid Tumors	NCT01455259	Malignant Melan...	AdCD40L	18 Years -	Uppsala University
Clinical Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema (AdeLE)	NCT03658967	Secondary Lymph...	Lymfactin® (1x1... Placebo	18 Years - 70 Years	Herantis Pharma Plc.
Clinical Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema (AdeLE)	NCT03658967	Secondary Lymph...	Lymfactin® (1x1... Placebo	18 Years - 70 Years	Herantis Pharma Plc.

Spots Global Cancer Trial Database for adenoviral vector