Intravenous Palifosfamide-tris in Combination With Etoposide and Carboplatin in Patients With Malignancies
This study is ongoing, but not recruiting participants.
Sponsor:
ZIOPHARM
Information provided by (Responsible Party):
ZIOPHARM
ClinicalTrials.gov Identifier:
NCT01242072
First received: November 12, 2010
Last updated: July 17, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignancy Cancer Non Small Cell Lung Cancer Small Cell Lung Cancer Testicular Cancer Thymoma Ovarian Cancer Osteosarcoma |
Drug: palifosfamide-tris |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by ZIOPHARM:
Primary Outcome Measures:
- Assess the safety profile [ Time Frame: 21 Days ] [ Designated as safety issue: Yes ]Adverse events, vital signs, physical examination, laboratory data and concomitant medications
Secondary Outcome Measures:
- Determine the maximum tolerated dose [ Time Frame: Up to 21 days ] [ Designated as safety issue: Yes ]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.
- Assess early signs of efficacy [ Time Frame: duration of study ] [ Designated as safety issue: No ]To assess early signs of efficacy using this investigational combination in this patient population
| Estimated Enrollment: | 12 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PaCE
Palifosfamide, Carboplatin and Etoposide
|
Drug: palifosfamide-tris
Intravenous on days 1, 2 and 3 of each 21-day cycle for up to 4 cycles
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242072
Locations
| United States, Indiana | |
| Indiana University Simon Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| Horizon Oncology Research | |
| Lafayette, Indiana, United States, 47905 | |
| Medical Consultants, PC | |
| Muncie, Indiana, United States, 47303 | |
| United States, Missouri | |
| Washington University | |
| St. Louis, Missouri, United States, 63110 | |
Sponsors and Collaborators
ZIOPHARM
More Information
No publications provided
| Responsible Party: | ZIOPHARM |
| ClinicalTrials.gov Identifier: | NCT01242072 History of Changes |
| Other Study ID Numbers: | IPM1004 |
| Study First Received: | November 12, 2010 |
| Last Updated: | July 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by ZIOPHARM:
|
malignancy etoposide and carboplatin non small cell lung cancer small cell lung cancer |
testicular cancer thymoma ovarian cancer osteosarcoma |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma, Non-Small-Cell Lung Lung Neoplasms Osteosarcoma Ovarian Neoplasms Testicular Neoplasms Thymoma Small Cell Lung Carcinoma Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Sarcoma Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Genital Neoplasms, Male Genital Diseases, Male |
ClinicalTrials.gov processed this record on May 23, 2013