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

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ziopharm
• Treatments: Carboplatin; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard

Criteria

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