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

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

On Day 1 of each cycle (21 days), 150 mg/m2 IV (intravenous) palifosfamide tris and 75 mg/m2 IV doxorubicin are administered on the same day. Doxorubicin administration will be initiated approximately 60 minutes after the completion of palifosfamide tris dosing. Palifosfamide tris alone is administered on Days 2 and 3, every 3 weeks (one 21-day cycle).

On Day 1 of each cycle, 75 mg/m2 doxorubicin is administered IV.

Palifosfamide Tris and Doxorubicin

Jonathan J Lewis, MD, PhD

This is a randomized, controlled trial to evaluate the clinical benefit of palifosfamide tris administered with doxorubicin in combination, compared with single-agent doxorubicin administered in subjects diagnosed with unresectable or metastatic soft-tissue sarcoma (STS). Subjects who meet the entry criteria will be randomized into 1 of 2 arms: either to receive palifosfamide tris plus doxorubicin or treatment with single-agent doxorubicin. Subjects will be anthracyclin naïve.

A Study of Palifosfamide Tris Plus Doxorubicin Versus Doxorubicin in Unresectable or Metastatic Soft-tissue Sarcoma

A Phase II Multicenter, Parallel Group, Randomized Study of Palifosfamide Tris Plus Doxorubicin Versus Doxorubicin in Subjects With Unresectable or Metastatic Soft-tissue Sarcoma

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
A Study of Palifosfamide Tris Plus Doxorubicin Versus Doxorubicin in Unresectable or Metastatic Soft-tissue Sarcoma	NCT00718484	Soft Tissue Sar...	Palifosfamide T... Doxorubicin	18 Years -	Alaunos Therapeutics
A Study of Palifosfamide Tris Plus Doxorubicin Versus Doxorubicin in Unresectable or Metastatic Soft-tissue Sarcoma	NCT00718484	Soft Tissue Sar...	Palifosfamide T... Doxorubicin	18 Years -	Alaunos Therapeutics

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