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

Cancer Clinical Trial

Official title:

A Phase I Study of Intravenous (IV) Palifosfamide-tris Administered in Combination With IV Etoposide and IV Carboplatin in Patients With Malignancies for Which Etoposide and Carboplatin Are an Appropriate Choice

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01242072
• Other study ID #: IPM1004
• Status: Active, not recruiting
• Phase: Phase 1
• First received: November 12, 2010
• Last updated: July 17, 2012
• Start date: November 2010
• Est. completion date: December 2012

Study information

• Verified date: July 2012
• Source: Ziopharm
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Malignancy
• Neoplasms
• Non Small Cell Lung Cancer
• Osteosarcoma
• Ovarian Cancer
• Ovarian Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma
• Testicular Cancer
• Testicular Neoplasms
• Thymoma

Intervention

Drug:
• palifosfamide-tris
Intravenous on days 1, 2 and 3 of each 21-day cycle for up to 4 cycles

Locations

Country	Name	City	State
United States	Indiana University Simon Cancer Center	Indianapolis	Indiana
United States	Horizon Oncology Research	Lafayette	Indiana
United States	Medical Consultants, PC	Muncie	Indiana
United States	Washington University	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Ziopharm

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the safety profile	Adverse events, vital signs, physical examination, laboratory data and concomitant medications	21 Days	Yes
Secondary	Determine the maximum tolerated dose	Each dose level cohort will be 3 subjects. After 3 subjects have received a regimen, there will be a minimum observation period of 1 full cycle (21 days) for each of the 3 subjects before enrollment of the group of subjects at the next dose level.	Up to 21 days	Yes
Secondary	Assess early signs of efficacy	To assess early signs of efficacy using this investigational combination in this patient population	duration of study	No