Intravenous Palifosfamide-tris in Combination With Etoposide and Carboplatin in Patients With Malignancies

Alaunos Therapeutics

Status and phase: Unknown; Phase 1

Conditions: Osteosarcoma; Testicular Cancer; Thymoma; Small Cell Lung Cancer; Non Small Cell Lung Cancer; Cancer; Ovarian Cancer; Malignancy

Treatments: Drug: palifosfamide-tris

Study type: Interventional

Funder types: Industry

Identifiers

NCT01242072

IPM1004

Details and patient eligibility

About

This an an open-label study to define the safety profile and the maximum tolerated dose and confirm the clinical effective dose of palifosfamide-tris given intravenously in combination with etoposide and carboplatin in a wide range of cancers which etoposide and carboplatin are normally given. Once the maximum dose of palifosfamide-tris is determined,a Phase II study using the 3 agents combined will begin.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years old or greater
• Malignancy scheduled to receive etoposide and carboplatin therapy
• Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1
• Adequate bone marrow, liver, renal function and coagulation status
• Informed consent
• Agree to use birth control through 28 days of last treatment dose
• Pregnancy test for women of child-bearing potential
• No available standard therapy

Exclusion criteria

• Allergy to the the study treatment drugs
• Unstable current medical condition
• Presence or history of injury to the urinary tract
• Active infection
• Major surgery within 4 weeks prior to treatment
• Minor surgery within 2 weeks prior to treatment
• Current acute steroid therapy or taper
• Currently pregnant or nursing
• Substance abuse or condition that may interfere with participation
• Received other investigational drugs within 30 days
• Within 4 weeks of their last chemotherapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

PaCE

Experimental group

Description:

Palifosfamide, Carboplatin and Etoposide

Treatment:

Drug: palifosfamide-tris